<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/NCT02249247</url>
  </required_header>
  <id_info>
    <org_study_id>543.17</org_study_id>
    <nct_id>NCT02249247</nct_id>
  </id_info>
  <brief_title>Effect of Treatment With BIIL 284 BS on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Effect of 12-week Treatment of 5, 25 or 75 mg BIIL 284 BS on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (Double-blind, Double Dummy, Placebo-controlled, Randomized, Parallel Group, Dose Ranging Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to investigate the effect of 12-week treatment with three doses (5, 25 and 75 mg) BIIL&#xD;
      284 BS on exercise endurance, lung function, quality of life, spontaneous sputum and safety&#xD;
      in patients with chronic obstructive pulmonary disease (COPD)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2001</start_date>
  <primary_completion_date type="Actual">August 2002</primary_completion_date>
  <phase>Phase 2</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in exercise endurance</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>evaluated by constant work load test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in breathlessness during constant work load test</measure>
    <time_frame>Week 4 and week 12 weeks after start of treatment</time_frame>
    <description>measured by Modified Borg scale: Dyspnea score, leg discomfort</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in forced expiratory volume in one second (FEV1)</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>assessed by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in forced vital capacity (FVC)</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>assessed by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in forced expiratory flow at 25%-75% of FVC (FEF25-75%)</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>assessed by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in inspiratory capacity (IC)</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>assessed by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in slow vital capacity (SVC)</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>assessed by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in thoracic gas volume</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>assessed by body plethysmography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in total lung capacity</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>assessed by body plethysmography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in residual volume</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>assessed by body plethysmography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in specific airway conductance</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>assessed by body plethysmography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Mahler dyspnoea questionnaire</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>Baseline dyspnoea index / transitional dyspnoea index (BDI/TDI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in chronic respiratory disease questionnaire (CRDQ)</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in carbon monoxide diffusing capacity (DLco)</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in diffusing capacity of carbon monoxide corrected for alveolar volume (DLco/VA)</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in peak expiratory flow rate (PEFR) daily patient record</measure>
    <time_frame>Pre-dose, up to 14 weeks after start of treatment</time_frame>
    <description>assessed a.m. and p.m. in daily patient record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in 24-hours spontaneous sputum wet weight</measure>
    <time_frame>Pre-dose, up 12 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in oxygen saturation during constant work load test</measure>
    <time_frame>Pre-dose, up to 12 weeks after start of treatment</time_frame>
    <description>assessed by pulse oximetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in global evaluation assessed by investigator on a 4-point scale</measure>
    <time_frame>Pre-dose, up to 14 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically relevant changes in vital signs (pulse rate, blood pressure)</measure>
    <time_frame>Pre-dose, up to 14 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically relevant changes in ECG</measure>
    <time_frame>Pre-dose, up to 14 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically relevant changes in laboratory tests</measure>
    <time_frame>Pre-dose, up to 14 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 17 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with acute COPD exacerbations</measure>
    <time_frame>Up to 17 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">577</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Low dose of BIIL 284 BS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium dose of BIIL 284 BS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose of BIIL 284 BS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low dose of BIIL 284 BS tablets</intervention_name>
    <arm_group_label>Low dose of BIIL 284 BS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medium dose of BIIL 284 BS tablets</intervention_name>
    <arm_group_label>Medium dose of BIIL 284 BS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>High dose of BIIL 284 BS tablets</intervention_name>
    <arm_group_label>High dose of BIIL 284 BS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of COPD as defined by the American Thoracic Society (ATS) criteria.&#xD;
             Patients had to have relatively stable airway obstruction with a FEV1 ≥ 20 % and ≤ 70&#xD;
             % of predicted value and FEV1/ FVC ≤ 70 % at screening Visit 1. Predicted normal&#xD;
             values were based on the guidelines for standardised lung function testing of the&#xD;
             European Community for Steel and Coal (ECSC) for patients of the Caucasian race and on&#xD;
             the predicted equations for patients belonging to the Black race. Patients had to have&#xD;
             lung hyperinflation as demonstrated by thoracic gas volume box (TGVbox) ≥ 100 % of&#xD;
             predicted value (same as predicted value for functional residual capacity (FRC)&#xD;
             measured by body plethysmography)&#xD;
&#xD;
          -  Males or females aged 40 years or older. Female patients of childbearing potential&#xD;
             could not participate in this study. Female patients had to be either:&#xD;
&#xD;
               -  surgically sterilised by hysterectomy or bilateral tubal ligation, or&#xD;
&#xD;
               -  post-menopausal for at least two years&#xD;
&#xD;
          -  A smoking history of more than ten pack-years (p.y.). A p.y. was defined as the&#xD;
             equivalent of smoking one pack of 20 cigarettes per day for a year&#xD;
&#xD;
          -  Patients had to be able to perform pulmonary function testings (PFTs), exercise&#xD;
             endurance test not terminated due to leg discomfort alone or other restrictions&#xD;
             diseases (e.g. claudicatio intermittens, etc.) only and maintain records during the&#xD;
             study period as required in the protocol&#xD;
&#xD;
          -  All patients had to sign both informed consent forms (one on specific study&#xD;
             procedures, one related to DNA derived determinations) prior to participation in the&#xD;
             trial i.e., prior to pre-study washout of their usual pulmonary medications if they&#xD;
             agreed to participate in both portions of the trial. The patient was not obligated to&#xD;
             participate in the DNA collection portion of the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical and/or radiographic evidence and/or antibiotic treatment of an upper or lower&#xD;
             respiratory tract infection within the previous four weeks or during the screening&#xD;
             period of this study&#xD;
&#xD;
          -  Significant diseases other than COPD were excluded. A significant disease was defined&#xD;
             as a disease which in the opinion of the investigator could either put the patient at&#xD;
             risk because of participation in the study or a disease which could influence the&#xD;
             results of the study or the patient's ability to participate in the study. Patients&#xD;
             with inflammatory diseases, e.g., Rheumatoid Arthritis (RA), osteoarthritis, and those&#xD;
             with autoimmune diseases were excluded&#xD;
&#xD;
          -  Clinically significant abnormal baseline haematology, liver function, blood chemistry&#xD;
             or urinalysis. If the abnormality defined a disease listed as an exclusion criterion&#xD;
             the patient was excluded&#xD;
&#xD;
          -  A recent history (i.e., within six months) of myocardial infarction&#xD;
&#xD;
          -  A recent history (i.e., within three months) of refractory heart failure or unstable&#xD;
             arrhythmia requiring treatment&#xD;
&#xD;
          -  Patients with known tuberculosis&#xD;
&#xD;
          -  A history of cancer within the last five years. Patients with treated basal cell&#xD;
             carcinoma or cutaneous squamous cell carcinoma were allowed&#xD;
&#xD;
          -  A history of life-threatening airway obstruction or a history of cystic fibrosis&#xD;
&#xD;
          -  Previous thoracotomy with pulmonary resection. Patients with a history of a&#xD;
             thoracotomy without pulmonary resection were evaluated as per exclusion criterion No.&#xD;
             2&#xD;
&#xD;
          -  A change in pulmonary therapy, including rehabilitation therapy, within the four weeks&#xD;
             prior to the first screening Visit (Visit 1) in order to control the patient's COPD&#xD;
&#xD;
          -  A history of asthma or a total blood eosinophil count ≥ 600/mm3. A repeat eosinophil&#xD;
             count was not conducted in these patients&#xD;
&#xD;
          -  A history (within the past five years) of and/or current alcohol abuse and/or drug&#xD;
             abuse&#xD;
&#xD;
          -  Use of an investigational drug within one month or six half lives (which ever is&#xD;
             greater) of the first Screening Visit (Visit 1)&#xD;
&#xD;
          -  Patients requiring oxygen therapy 24 hours a day or requiring oxygen during exercise.&#xD;
             Patients that desaturated during exercise were only excluded upon medical judgement of&#xD;
             the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02249247
org study id: 543.17
nct id: NCT02249247
lead sponsor: 
Study to investigate the effect of 12-week treatment with three doses (5, 25 and 75 mg) BIIL
      284 BS on exercise endurance, lung function, quality of life, spontaneous sputum and safety
      in patients with chronic obstructive pulmonary disease (COPD)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Changes in exercise endurance
time frame: Pre-dose, up to 12 weeks after start of treatment
description: evaluated by constant work load test
measure: Changes in breathlessness during constant work load test
time frame: Week 4 and week 12 weeks after start of treatment
description: measured by Modified Borg scale: Dyspnea score, leg discomfort
measure: Changes in forced expiratory volume in one second (FEV1)
time frame: Pre-dose, up to 12 weeks after start of treatment
description: assessed by spirometry
measure: Changes in forced vital capacity (FVC)
time frame: Pre-dose, up to 12 weeks after start of treatment
description: assessed by spirometry
measure: Changes in forced expiratory flow at 25%-75% of FVC (FEF25-75%)
time frame: Pre-dose, up to 12 weeks after start of treatment
description: assessed by spirometry
measure: Changes in inspiratory capacity (IC)
time frame: Pre-dose, up to 12 weeks after start of treatment
description: assessed by spirometry
measure: Changes in slow vital capacity (SVC)
time frame: Pre-dose, up to 12 weeks after start of treatment
description: assessed by spirometry
measure: Change in thoracic gas volume
time frame: Pre-dose, up to 12 weeks after start of treatment
description: assessed by body plethysmography
measure: Changes in total lung capacity
time frame: Pre-dose, up to 12 weeks after start of treatment
description: assessed by body plethysmography
measure: Changes in residual volume
time frame: Pre-dose, up to 12 weeks after start of treatment
description: assessed by body plethysmography
measure: Changes in specific airway conductance
time frame: Pre-dose, up to 12 weeks after start of treatment
description: assessed by body plethysmography
measure: Changes in Mahler dyspnoea questionnaire
time frame: Pre-dose, up to 12 weeks after start of treatment
description: Baseline dyspnoea index / transitional dyspnoea index (BDI/TDI)
measure: Changes in chronic respiratory disease questionnaire (CRDQ)
time frame: Pre-dose, up to 12 weeks after start of treatment
measure: Changes in carbon monoxide diffusing capacity (DLco)
time frame: Pre-dose, up to 12 weeks after start of treatment
measure: Changes in diffusing capacity of carbon monoxide corrected for alveolar volume (DLco/VA)
time frame: Pre-dose, up to 12 weeks after start of treatment
measure: Changes in peak expiratory flow rate (PEFR) daily patient record
time frame: Pre-dose, up to 14 weeks after start of treatment
description: assessed a.m. and p.m. in daily patient record
measure: Changes in 24-hours spontaneous sputum wet weight
time frame: Pre-dose, up 12 weeks after start of treatment
measure: Changes in oxygen saturation during constant work load test
time frame: Pre-dose, up to 12 weeks after start of treatment
description: assessed by pulse oximetry
measure: Changes in global evaluation assessed by investigator on a 4-point scale
time frame: Pre-dose, up to 14 weeks after start of treatment
measure: Clinically relevant changes in vital signs (pulse rate, blood pressure)
time frame: Pre-dose, up to 14 weeks after start of treatment
measure: Clinically relevant changes in ECG
time frame: Pre-dose, up to 14 weeks after start of treatment
measure: Clinically relevant changes in laboratory tests
time frame: Pre-dose, up to 14 weeks after start of treatment
measure: Number of patients with adverse events
time frame: Up to 17 weeks
measure: Number of patients with acute COPD exacerbations
time frame: Up to 17 weeks
arm group label: Low dose of BIIL 284 BS
arm group type: Experimental
arm group label: Medium dose of BIIL 284 BS
arm group type: Experimental
arm group label: High dose of BIIL 284 BS
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Low dose of BIIL 284 BS tablets
arm group label: Low dose of BIIL 284 BS
intervention type: Drug
intervention name: Medium dose of BIIL 284 BS tablets
arm group label: Medium dose of BIIL 284 BS
intervention type: Drug
intervention name: High dose of BIIL 284 BS tablets
arm group label: High dose of BIIL 284 BS
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive