<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02207829</url>
  </required_header>
  <id_info>
    <org_study_id>201316</org_study_id>
    <nct_id>NCT02207829</nct_id>
  </id_info>
  <brief_title>A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>A Randomized, Blinded, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Tiotropium 18 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate&#xD;
      the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)]&#xD;
      when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD)&#xD;
      administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in&#xD;
      Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the&#xD;
      run-in period, subjects who meet the randomization criteria will be randomized to receive&#xD;
      UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via&#xD;
      HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo&#xD;
      administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an&#xD;
      outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in&#xD;
      period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28&#xD;
      (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in&#xD;
      Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day&#xD;
      168 (Visit 10). The total duration of subject participation in the study will be&#xD;
      approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic&#xD;
      visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects&#xD;
      will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be&#xD;
      obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits&#xD;
      3 to 7.&#xD;
&#xD;
      HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH &amp; Co. KG.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 1, 2014</start_date>
  <completion_date type="Actual">June 15, 2015</completion_date>
  <primary_completion_date type="Actual">May 25, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85</measure>
    <time_frame>Baseline (BL) and Day 85</time_frame>
    <description>FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1017</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Umeclidinium 62.5 mcg + placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive UMEC Inhalation Powder 62.5 mcg once daily via nDPI plus placebo once daily via HANDIHALER inhaler for 12 weeks (24 weeks in Germany). Subjects will be instructed to take one inhalation each morning from both the nDPI and the HANDIHALER inhaler</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tiotropium 18mcg + placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive Tiotropium 18 mcg once daily via HANDIHALER inhaler plus placebo once daily via nDPI for 12 weeks (24 weeks in Germany). Subjects will be instructed to take one inhalation each morning from both the nDPI and the HANDIHALER inhaler</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Umeclidinium</intervention_name>
    <description>Umeclidinium 62.5 mcg once daily in the morning via nDPI</description>
    <arm_group_label>Umeclidinium 62.5 mcg + placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Umeclidinium matching placebo</intervention_name>
    <description>Umeclidinium matching placebo once daily in the morning via nDPI</description>
    <arm_group_label>Umeclidinium 62.5 mcg + placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tiotropium</intervention_name>
    <description>Tiotropium 18 mcg once daily in the morning via HANDIHALER inhaler</description>
    <arm_group_label>Tiotropium 18mcg + placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tiotropium matching placebo</intervention_name>
    <description>Tiotropium matching placebo once daily in the morning via HANDIHALER inhaler</description>
    <arm_group_label>Tiotropium 18mcg + placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type of subject: outpatient.&#xD;
&#xD;
          -  Informed Consent: A signed and dated written informed consent prior to study&#xD;
             participation.&#xD;
&#xD;
          -  Age: Subjects 40 years of age or older at Visit 1.&#xD;
&#xD;
          -  Gender: Male and female subjects are eligible to participate in the study. A female is&#xD;
             eligible to enter and participate in the study if she is of:&#xD;
&#xD;
        Non-child bearing potential (i.e., physiologically incapable of becoming pregnant,&#xD;
        including any female who is post-menopausal or surgically sterile). Surgically sterile&#xD;
        females are defined as those with a documented hysterectomy and/or bilateral oophorectomy&#xD;
        or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater&#xD;
        than 1 year with an appropriate clinical profile, e.g., age appropriate, &gt; 45 years, in the&#xD;
        absence of hormone replacement therapy. OR Child bearing potential, has a negative&#xD;
        pregnancy test at screening, and agrees to one of the acceptable contraceptive methods used&#xD;
        consistently and correctly (i.e., in accordance with the approved product label and the&#xD;
        instructions of the physician for the duration of the study - screening to follow-up&#xD;
        contact). - Diagnosis: An established clinical history of COPD in accordance with the&#xD;
        definition by the American Thoracic Society/European Respiratory Society&#xD;
&#xD;
          -  Smoking History: Current or former cigarette smokers with a history of cigarette&#xD;
             smoking of &gt;=10 pack-years [number of pack years = (number of cigarettes per day / 20)&#xD;
             x number of years smoked (e.g. 20 cigarettes per day for 10 years, or 10 cigarettes&#xD;
             per day for 20 years both equal 10 pack-years)]. Former smokers are defined as those&#xD;
             who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use&#xD;
             cannot be used to calculate pack-year history.&#xD;
&#xD;
          -  Severity of Disease: A pre and post-albuterol/salbutamol FEV1/ Forced Vital Capacity&#xD;
             (FVC) ratio of &lt;0.70 and a post-albuterol/salbutamol FEV1 of &gt;=30% and &lt;=70% of&#xD;
             predicted normal values at Visit 1. Predicted values will be based upon the ERS Global&#xD;
             Lung Function Initiative&#xD;
&#xD;
          -  Dyspnea: A score of &gt;=2 on the Modified Medical Research Council Dyspnea Scale (mMRC)&#xD;
             at Visit 1.&#xD;
&#xD;
          -  French subjects: In France, a subject will be eligible for inclusion in this study&#xD;
             only if either affiliated to or a beneficiary of a social security category.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant&#xD;
             during the study.&#xD;
&#xD;
          -  Asthma: A current diagnosis of asthma.&#xD;
&#xD;
          -  Other Respiratory Disorders: Known Alpha-1 antitrypsin deficiency, active lung&#xD;
             infections (such as tuberculosis), and lung cancer are absolute exclusionary&#xD;
             conditions. A subject who, in the opinion of the investigator, has any other&#xD;
             significant respiratory conditions in addition to COPD should be excluded. Examples&#xD;
             may include clinically significant bronchiectasis, pulmonary hypertension,&#xD;
             sarcoidosis, or interstitial lung disease.&#xD;
&#xD;
          -  Other Diseases/Abnormalities: Any subject who is considered unlikely to survive the&#xD;
             duration of the study period or has any rapidly progressing disease or immediate&#xD;
             life-threatening illness (e.g. cancer). In addition, any subject who has any condition&#xD;
             (e.g. neurological condition) that is likely to affect respiratory function should not&#xD;
             be included in the study.&#xD;
&#xD;
          -  Severe Hepatic Impairment: Patients with severe hepatic impairment (Child-Pugh class&#xD;
             C) should be excluded unless, in the opinion of the investigator, the benefit is&#xD;
             likely to outweigh the risk.&#xD;
&#xD;
          -  Moderate to severe Renal Impairment: Patients with moderate to severe renal impairment&#xD;
             (e.g., end-stage renal disease requiring dialysis) should be excluded, unless in the&#xD;
             opinion of the investigator, the benefit is likely to outweigh the risk.&#xD;
&#xD;
          -  Unstable or life threatening cardiac disease: Long-acting muscarinic antagonists&#xD;
             (LAMAs) should be used with caution in subjects with severe cardiovascular disease. In&#xD;
             the opinion of the investigator, use should only be considered if the benefit is&#xD;
             likely to outweigh the risk in conditions such as: Myocardial infarction or unstable&#xD;
             angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring&#xD;
             intervention in the last 3 months; New York Heart Association Class IV heart failure&#xD;
&#xD;
          -  Contraindications: Any history of allergy or hypersensitivity to any&#xD;
             anticholinergic/muscarinic receptor antagonist, sympathomimetic, lactose/milk protein&#xD;
             or magnesium stearate.&#xD;
&#xD;
          -  Antimuscarinic effects: Subjects with medical conditions such as narrow-angle&#xD;
             glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction should&#xD;
             only be included if, in the opinion of the study physician, the benefit outweighs the&#xD;
             risk.&#xD;
&#xD;
          -  Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit&#xD;
             1.&#xD;
&#xD;
          -  Lung Resection: Lung volume reduction surgery within the 12 months prior to Visit 1.&#xD;
&#xD;
          -  12-Lead electrocardiogram (ECG): Investigators will be provided with ECG reviews&#xD;
             conducted by a centralized independent cardiologist to assist in evaluation of subject&#xD;
             eligibility. The Investigator will determine the clinical significance of each&#xD;
             abnormal ECG finding in relation to the subject's medical history and exclude subjects&#xD;
             who would be at undue risk by participating in the trial. Subjects with the following&#xD;
             abnormalities are excluded from participation in the study: Atrial fibrillation with&#xD;
             rapid ventricular rate &gt;120 beats per minute; Sustained or nonsustained ventricular&#xD;
             tachycardia; Second degree heart block Mobitz type II or third degree heart block&#xD;
             (unless pacemaker or defibrillator had been inserted)&#xD;
&#xD;
          -  Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour&#xD;
             period required prior to spirometry testing at each study visit.&#xD;
&#xD;
          -  Medications Prior to Screening: Use of the following medications according to the&#xD;
             following defined time intervals prior to Visit 1: Depot corticosteroids-12 weeks;&#xD;
             Systemic, oral or parenteral corticosteroids- 6 weeks; Antibiotics (for lower&#xD;
             respiratory tract infection)- 6 weeks ; long-acting beta2-agonists/inhaled&#xD;
             corticosteroids (LABA/ICS) combination products if LABA/ICS therapy is discontinued&#xD;
             completely-30 days; LABA/ICS combination products only If discontinuing ICS/LABA&#xD;
             therapy and switching to ICS monotherapy- 48 hours for the salmeterol or formoterol&#xD;
             component, 14 days for the vilanterol component [The dose of ICS must be a dose of&#xD;
             fluticasone propionate (FP) or equivalent but not to exceed 1000 mcg/day] ; Use of ICS&#xD;
             at a dose &gt;1000 mcg/day of FP or equivalent- 30 days; Initiation or discontinuation of&#xD;
             ICS use-30 days (Use of ICS is permitted provided the dose does not exceed 1000mcg of&#xD;
             FP or equivalent; ICS use not to be initiated or discontinued within 30 days prior to&#xD;
             Visit 1, except for subjects on LABA/ICS therapy who may discontinue the ICS/LABA&#xD;
             product as indicated in the table above and switch to ICS monotherapy);&#xD;
             Phosphodiesterase 4 (PDE4) Inhibitor (roflumilast)- 14 days; Inhaled long acting beta2&#xD;
             agonists (LABAs): salmeterol, formoterol-48 hours, olodaterol, indacaterol,&#xD;
             vilanterol- 14 days; LAMAs: tiotropium, aclidinium, glycopyrronium, umeclidinium- 7&#xD;
             days; LAMA/LABA combination products if LAMA/LABA therapy is discontinued completely-&#xD;
             Apply whichever mono component has the longest washout; Theophyllines- 48 hours; Oral&#xD;
             beta2-agonists: Long-acting- 48 hours, Short-acting 12 hours; Inhaled short acting&#xD;
             beta2-agonists- 4 hours (Use of study provided albuterol/salbutamol is permitted&#xD;
             during the study, except in the 4-hour period prior to spirometry testing) ; Inhaled&#xD;
             short-acting anticholinergics- 4 hours; Inhaled short-acting&#xD;
             anticholinergic/short-acting beta2-agonist combination products- 4 hours; Any other&#xD;
             investigational medication - 30 days or within 5 drug half lives (whichever is&#xD;
             longer).&#xD;
&#xD;
          -  Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed&#xD;
             for greater than 12 hours a day. As-needed oxygen use (i.e. &lt;=12 hours per day) is not&#xD;
             exclusionary.&#xD;
&#xD;
          -  Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use)&#xD;
             of short-acting bronchodilators (e.g. albuterol/salbutamol) via nebulized therapy.&#xD;
&#xD;
          -  Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary&#xD;
             rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the&#xD;
             maintenance phase of a pulmonary rehabilitation program are not excluded.&#xD;
&#xD;
          -  Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2&#xD;
             years prior to Visit 1.&#xD;
&#xD;
          -  Affiliation with Investigator Site: Is an investigator, sub-investigator, study&#xD;
             coordinator, employee of a participating investigator or study site, or immediate&#xD;
             family member of the aforementioned that is involved in this study.&#xD;
&#xD;
          -  Inability to read: In the opinion of the investigator, any subject who is unable to&#xD;
             read and/or write would not be able to complete a questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1425BEN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aires</city>
        <zip>C1426ABP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R2K 3S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1A 3R5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Truro</city>
        <state>Nova Scotia</state>
        <zip>B2N 1L2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3E 1H5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M3J 2C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2R 1V6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St-Charles-Borromée</city>
        <state>Quebec</state>
        <zip>J6E 2B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Quebec</city>
        <zip>G1W 4R4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santiago</city>
        <state>Región Metro De Santiago</state>
        <zip>7500692</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santiago</city>
        <state>Región Metro De Santiago</state>
        <zip>7860406</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santiago</city>
        <state>Región Metro De Santiago</state>
        <zip>8360160</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valparaiso</city>
        <state>Valparaíso</state>
        <zip>2341131</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Talcahuano</city>
        <zip>4270918</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aarhus C</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kobenhavn NV</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Odense</city>
        <zip>DK-5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bletterans</city>
        <zip>39140</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nantes cedex 2</city>
        <zip>44277</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toulon</city>
        <zip>83000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tours</city>
        <zip>37100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vieux Condé</city>
        <zip>59690</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Aschaffenburg</city>
        <state>Bayern</state>
        <zip>63739</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Neu-Isenburg</city>
        <state>Hessen</state>
        <zip>63263</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rodgau</city>
        <state>Hessen</state>
        <zip>63110</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wiesbaden</city>
        <state>Hessen</state>
        <zip>65187</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Teuchern</city>
        <state>Sachsen-Anhalt</state>
        <zip>06682</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dresden</city>
        <state>Sachsen</state>
        <zip>01069</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Schmoelln</city>
        <state>Thueringen</state>
        <zip>04626</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10717</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>13156</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Riccione (RN)</city>
        <state>Emilia-Romagna</state>
        <zip>47838</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Torrette (AN)</city>
        <state>Marche</state>
        <zip>60020</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pisa</city>
        <state>Toscana</state>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Negrar</city>
        <state>Veneto</state>
        <zip>37024</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucheon-Si, Gyeonggi-Do</city>
        <zip>420-767</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>130-709</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>134-814</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>136-705</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>156-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wonju-si, Gangwon-do</city>
        <zip>220-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bacau</city>
        <zip>600252</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Braila</city>
        <zip>810003</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <zip>030303</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Codlea</city>
        <zip>505100</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Comuna Alexandru Cel Bun</city>
        <zip>617507</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Deva</city>
        <zip>330084</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Focsani</city>
        <zip>620043</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Galati</city>
        <zip>800189</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ploiesti</city>
        <zip>100379</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Timisoara</city>
        <zip>300310</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>153000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163001</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barnaul</city>
        <zip>656 045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Irkutsk</city>
        <zip>664003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Izhevsk</city>
        <zip>426063</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kemerovo</city>
        <zip>650002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>115 280</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>117997</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630102</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194356</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>196084</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>198260</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sestroretsk</city>
        <zip>197706</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sochi</city>
        <zip>354057</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194356</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>198216</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St.Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stavropol</city>
        <zip>355017</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tomsk</city>
        <zip>634050</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ufa</city>
        <zip>450071</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vladimir</city>
        <zip>600023</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Port Elizabeth</city>
        <state>Eastern Cape</state>
        <zip>6001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boksburg</city>
        <state>Gauteng</state>
        <zip>1459</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bellville</city>
        <zip>7530</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Durban</city>
        <zip>4001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Korsten</city>
        <zip>6014</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lynnwood Ridge, Pretoria</city>
        <zip>0040</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mowbray</city>
        <zip>7700</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Somerset West</city>
        <zip>7130</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sophiatown</city>
        <zip>2129</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Welkom</city>
        <zip>9460</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dnipropetrovsk</city>
        <zip>49074</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61039</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kiev</city>
        <zip>03680</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kryvyi Rig</city>
        <zip>50096</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>03038</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Poltava</city>
        <zip>36038</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69050</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>January 11, 2016</results_first_submitted>
  <results_first_submitted_qc>January 11, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 9, 2016</results_first_posted>
  <last_update_submitted>January 18, 2018</last_update_submitted>
  <last_update_submitted_qc>January 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>inhaler critical errors</keyword>
  <keyword>double-dummy</keyword>
  <keyword>novel dry powder inhaler</keyword>
  <keyword>inhaler preference</keyword>
  <keyword>tiotropium</keyword>
  <keyword>umeclidinium</keyword>
  <keyword>long-acting muscarinic antagonist</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tiotropium Bromide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>201316</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201316</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201316</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201316</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201316</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201316</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201316</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants (Par.), with clinical history of chronic obstructive pulmonary disease, who met eligibility criteria at screening were enrolled in a 7 to 14 days run-in period. Eligible par. were randomized (1:1) to receive umeclidinium or tiotropium. A total of 1214 par. were screened; 1017 par. were randomized and entered into the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Umeclidinium 62.5 mcg+Placebo QD</title>
          <description>Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.</description>
        </group>
        <group group_id="P2">
          <title>Tiotropium 18 mcg+Placebo QD</title>
          <description>Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="509"/>
                <participants group_id="P2" count="508"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="467"/>
                <participants group_id="P2" count="474"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Umeclidinium 62.5 mcg+Placebo QD</title>
          <description>Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.</description>
        </group>
        <group group_id="B2">
          <title>Tiotropium 18 mcg+Placebo QD</title>
          <description>Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="509"/>
            <count group_id="B2" value="508"/>
            <count group_id="B3" value="1017"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.4" spread="8.12"/>
                    <measurement group_id="B2" value="64.1" spread="8.28"/>
                    <measurement group_id="B3" value="64.2" spread="8.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="145"/>
                    <measurement group_id="B2" value="137"/>
                    <measurement group_id="B3" value="282"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="364"/>
                    <measurement group_id="B2" value="371"/>
                    <measurement group_id="B3" value="735"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>African American/African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Central/South Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japanese/East Asian/South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="458"/>
                    <measurement group_id="B2" value="457"/>
                    <measurement group_id="B3" value="915"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American/African Heritage &amp; White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85</title>
        <description>FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.</description>
        <time_frame>Baseline (BL) and Day 85</time_frame>
        <population>Per Protocol(PP) Population(pop): Participants(par) in the Intent-To-Treat pop who did not have a full protocol deviation considered to impact efficacy. Par represent those with data available at time point presented; however, all par. in the PP pop. without missing covariate information and &gt;=1 post BL measurement are included in analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Umeclidinium 62.5 mcg+Placebo QD</title>
            <description>Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.</description>
          </group>
          <group group_id="O2">
            <title>Tiotropium 18 mcg+Placebo QD</title>
            <description>Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85</title>
          <description>FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.</description>
          <population>Per Protocol(PP) Population(pop): Participants(par) in the Intent-To-Treat pop who did not have a full protocol deviation considered to impact efficacy. Par represent those with data available at time point presented; however, all par. in the PP pop. without missing covariate information and &gt;=1 post BL measurement are included in analysis</population>
          <units>Liter</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="392"/>
                <count group_id="O2" value="416"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.154" spread="0.0107"/>
                    <measurement group_id="O2" value="0.095" spread="0.0106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Alternate hypothesis: the difference between the trt means (umeclidinium minus tiotropium) would be &gt; -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to tiotropium.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.059</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.029</ci_lower_limit>
            <ci_upper_limit>0.088</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>On-treatment(trt) non-serious adverse events(AEs) and serious AEs are events occurring while par were on trt or events with an onset during follow-up period(up to 13 weeks). AE data for German subjects are only included for the first 12 weeks of trt.</time_frame>
      <desc>On-treatment non-serious AEs and SAEs were reported for the ITT Population comprised all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Umeclidinium 62.5 mcg+Placebo QD</title>
          <description>Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.</description>
        </group>
        <group group_id="E2">
          <title>Tiotropium 18 mcg+Placebo QD</title>
          <description>Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Congestive cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Lobar pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airway disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Non-Hodgkin's lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Bronchial carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="508"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="509"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="508"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02207829
org study id: 201316
nct id: NCT02207829
lead sponsor: 
has dmc: No
This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate
      the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)]
      when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD)
      administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in
      Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the
      run-in period, subjects who meet the randomization criteria will be randomized to receive
      UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via
      HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo
      administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an
      outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in
      period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28
      (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in
      Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day
      168 (Visit 10). The total duration of subject participation in the study will be
      approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic
      visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects
      will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be
      obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits
      3 to 7.

      HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85
time frame: Baseline (BL) and Day 85
description: FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.
arm group label: Umeclidinium 62.5 mcg + placebo
arm group type: Experimental
description: Subjects will receive UMEC Inhalation Powder 62.5 mcg once daily via nDPI plus placebo once daily via HANDIHALER inhaler for 12 weeks (24 weeks in Germany). Subjects will be instructed to take one inhalation each morning from both the nDPI and the HANDIHALER inhaler
arm group label: Tiotropium 18mcg + placebo
arm group type: Active Comparator
description: Subjects will receive Tiotropium 18 mcg once daily via HANDIHALER inhaler plus placebo once daily via nDPI for 12 weeks (24 weeks in Germany). Subjects will be instructed to take one inhalation each morning from both the nDPI and the HANDIHALER inhaler
intervention type: Drug
intervention name: Umeclidinium
description: Umeclidinium 62.5 mcg once daily in the morning via nDPI
arm group label: Umeclidinium 62.5 mcg + placebo
intervention type: Drug
intervention name: Umeclidinium matching placebo
description: Umeclidinium matching placebo once daily in the morning via nDPI
arm group label: Umeclidinium 62.5 mcg + placebo
intervention type: Drug
intervention name: Tiotropium
description: Tiotropium 18 mcg once daily in the morning via HANDIHALER inhaler
arm group label: Tiotropium 18mcg + placebo
intervention type: Drug
intervention name: Tiotropium matching placebo
description: Tiotropium matching placebo once daily in the morning via HANDIHALER inhaler
arm group label: Tiotropium 18mcg + placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Argentina
country: Canada
country: Chile
country: Denmark
country: France
country: Germany
country: Italy
country: Korea, Republic of
country: Romania
country: Russian Federation
country: South Africa
country: Ukraine
country: United States
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Tiotropium Bromide
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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