<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/NCT02242227</url>
  </required_header>
  <id_info>
    <org_study_id>1184.10</org_study_id>
    <nct_id>NCT02242227</nct_id>
  </id_info>
  <brief_title>Efficacy, Pharmacokinetics and Safety Comparison of Salmeterol Inhalation Powder Administered Via the HandiHaler® 2 and Serevent® Diskus® in Patients With Chronic Obstructive Pulmonary Disease (COPD)</brief_title>
  <official_title>A Single Dose, Placebo-controlled, Randomized, Double-blind, Double-dummy, Crossover Efficacy, Pharmacokinetics and Safety Comparison of Salmeterol Inhalation Powder (25 μg Salmeterol), Administered as the Xinafoate Salt From a Hard Polyethylene Capsule Via the HandiHaler® 2, and Serevent® Diskus® (50 μg Salmeterol) in Patients With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The primary objective of this trial was to establish non-inferiority of lung function&#xD;
      response to 25 μg salmeterol, administered as the xinafoate salt, in an inhalation powder&#xD;
      delivered from hard polyethylene (PE) capsules via the HandiHaler® 2 compared to Serevent®&#xD;
      Diskus® (salmeterol 50 μg, administered as the xinafoate salt) following single dose&#xD;
      inhalation in patients with COPD.&#xD;
&#xD;
      The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation&#xD;
      powder delivered by HandiHaler® 2 from the PE hard capsule and salmeterol xinafoate delivered&#xD;
      by Serevent® Diskus®, and to compare the safety of the two pharmaceutical forms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2005</start_date>
  <primary_completion_date type="Actual">February 2006</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in area under the curve for the time period 0 to 12 hours (AUC0-12h) of the forced expiratory volume in one second (FEV1)</measure>
    <time_frame>Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, and 12 hours post-dosing</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in peak FEV1</measure>
    <time_frame>within 3 hours post-dosing</time_frame>
    <description>Peak FEV1 is defined as the maximum FEV1 obtained within the first three hours post dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FEV1 AUC12-24h</measure>
    <time_frame>12, 14, 22, 23 and 24 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FEV1 AUC0-24h</measure>
    <time_frame>Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual FEV1 measurements at each time point</measure>
    <time_frame>Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forced vital capacity (FVC) AUC0-12h</measure>
    <time_frame>Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, and 12 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in peak FVC</measure>
    <time_frame>Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FVC AUC12-24h</measure>
    <time_frame>12, 14, 22, 23 and 24 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FVC AUC0-24h</measure>
    <time_frame>Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual FVC measurements at each time point</measure>
    <time_frame>Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 23 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)</measure>
    <time_frame>pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2; a time interval from 0 - 8 h is appropriate)</measure>
    <time_frame>pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ (terminal half-life of the analyte in plasma)</measure>
    <time_frame>pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRTih (mean residence time of the analyte in the body after inhalational administration)</measure>
    <time_frame>pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (apparent clearance of the analyte in the plasma after extravascular administration)</measure>
    <time_frame>pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)</measure>
    <time_frame>pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2 (amount of analyte that is eliminated in urine from the time interval t1 to t2)</measure>
    <time_frame>0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)</measure>
    <time_frame>0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)</measure>
    <time_frame>0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Salmeterol xinafoate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 μg Salmeterol inhalation powder administered via HandiHaler®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serevent® Diskus®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 μg Salmeterol (dry powder inhaler) administered via Diskus®</description>
  </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>Salmeterol xinafoate</intervention_name>
    <arm_group_label>Salmeterol xinafoate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Serevent® Diskus®</intervention_name>
    <arm_group_label>Serevent® Diskus®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (HandiHaler®)</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Serevent® Diskus®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (Diskus®)</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Salmeterol xinafoate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients must sign an informed consent consistent with International Conference on&#xD;
             Harmonization Good Clinical Practice (ICH-GCP) guidelines and local legislations prior&#xD;
             to any study-related procedures, which includes medication washout and restrictions&#xD;
&#xD;
          -  All patients must have a diagnosis of chronic obstructive pulmonary disease and must&#xD;
             meet the following spirometric criteria:&#xD;
&#xD;
               -  Patients must have relatively stable* airway obstruction with a pre-dose FEV1 ≤&#xD;
                  60% of predicted normal and FEV1 ≤ 70% of FVC at Visits 1 and 2.&#xD;
&#xD;
                    -  *The enrolment of patients who have had an exacerbation within six weeks&#xD;
                       prior to planned study entry should be postponed&#xD;
&#xD;
          -  At Visit 1, patients must demonstrate an improvement in FEV1 of ≥ 12% over the&#xD;
             pre-bronchodilator value 45 minutes after inhalation of 4 puffs of 100 μg salbutamol&#xD;
             (Sultanol® MDI)&#xD;
&#xD;
          -  Male or female patients 40 years of age or older&#xD;
&#xD;
          -  Patients must be current or ex-smokers with a smoking history of more than 10&#xD;
             pack-years ((Patients who have never smoked cigarettes must be excluded)&#xD;
&#xD;
          -  Patients must be able to perform technically acceptable pulmonary function tests&#xD;
             during the study period as required in the protocol&#xD;
&#xD;
          -  Patients must be able to inhale medication in a competent manner from the HandiHaler®&#xD;
             2 device and the Diskus® device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with significant diseases other than COPD will be excluded. A significant&#xD;
             disease is defined as a disease which in the opinion of the investigator may either&#xD;
             put the patient at risk because of participation in the study or a disease which may&#xD;
             influence the results of the study or the patient's ability to participate in the&#xD;
             study&#xD;
&#xD;
          -  Patients with a recent history (i.e., six months or less) of myocardial infarction&#xD;
&#xD;
          -  Patients who have been hospitalized for heart failure (New York Heart Association&#xD;
             (NYHA) class III or IV) within the past year&#xD;
&#xD;
          -  Patients with any unstable or life threatening cardiac arrhythmia or cardiac&#xD;
             arrhythmia requiring intervention or a change in drug therapy within the past year&#xD;
&#xD;
          -  Patients with malignancy for which the patient has undergone resection, radiation&#xD;
             therapy or chemotherapy within the last five years. Patients with treated basal cell&#xD;
             carcinoma are allowed&#xD;
&#xD;
          -  Patients with a history of asthma, allergic rhinitis or atopy or who have a total&#xD;
             blood eosinophil count ≥600/mm3&#xD;
&#xD;
          -  Patients with a history of life threatening pulmonary obstruction, or a history of&#xD;
             cystic fibrosis or clinically evident bronchiectasis&#xD;
&#xD;
          -  Patients with known active tuberculosis&#xD;
&#xD;
          -  Patients with significant alcohol or drug abuse within the past two years&#xD;
&#xD;
          -  Patients who have undergone thoracotomy with pulmonary resection. Patients with a&#xD;
             history of thoracotomy for other reasons should be evaluated as per exclusion&#xD;
             criterion No. 1&#xD;
&#xD;
          -  Patients who have completed a pulmonary rehabilitation program in the six weeks prior&#xD;
             to the Screening Visit (Visit 1) or patients who are currently in a pulmonary&#xD;
             rehabilitation program that will not be maintained throughout the duration of the&#xD;
             study&#xD;
&#xD;
          -  Patients who regularly use daytime oxygen therapy for more than one hour per day and&#xD;
             in the investigator's opinion will be unable to abstain from the use of oxygen therapy&#xD;
&#xD;
          -  Patients who are being treated with antihistamines (H1 receptor antagonists),&#xD;
             antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic&#xD;
             conditions&#xD;
&#xD;
          -  Patients who have been treated with cromolyn sodium or nedocromil sodium within one&#xD;
             month prior to Visit 1 or during the run-in period&#xD;
&#xD;
          -  Patients using oral corticosteroid medication at unstable doses (i.e., less than six&#xD;
             weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone&#xD;
             per day or 20 mg every other day&#xD;
&#xD;
          -  Patients with known hypersensitivity to beta-adrenergics, lactose or any other&#xD;
             components of the inhalation capsule delivery system or the Diskus®&#xD;
&#xD;
          -  Pregnant or nursing women or women of childbearing potential not using a medically&#xD;
             approved means of contraception for the previous three months (i.e. oral&#xD;
             contraceptives, intrauterine devices, diaphragm or subdermal implants, e.g.:&#xD;
             Norplant®)&#xD;
&#xD;
          -  Patients who have taken an investigational drug within one month or six half lives&#xD;
             (whichever is greater) prior to Visit 1&#xD;
&#xD;
          -  Patients who have been treated with oral beta-adrenergics within one month prior to&#xD;
             Visit 1 or during the run-in period&#xD;
&#xD;
          -  Patients who have been treated with theophylline preparations within one month prior&#xD;
             to Visit 1 or during the run-in period&#xD;
&#xD;
          -  Patients who have been treated with the long-acting anticholinergic tiotropium&#xD;
             (Spiriva®) within one month prior to Visit 1 or during the run-in period&#xD;
&#xD;
          -  Patients with any respiratory infections in the six weeks prior to the Screening Visit&#xD;
             (Visit 1) or during the run-in period. In the case of a respiratory infection during&#xD;
             the run-in period the latter may be extended up to six weeks&#xD;
&#xD;
          -  Patients who are currently participating in another study&#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 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salmeterol Xinafoate</mesh_term>
  </intervention_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/NCT02242227
org study id: 1184.10
nct id: NCT02242227
lead sponsor: 
The primary objective of this trial was to establish non-inferiority of lung function
      response to 25 μg salmeterol, administered as the xinafoate salt, in an inhalation powder
      delivered from hard polyethylene (PE) capsules via the HandiHaler® 2 compared to Serevent®
      Diskus® (salmeterol 50 μg, administered as the xinafoate salt) following single dose
      inhalation in patients with COPD.

      The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation
      powder delivered by HandiHaler® 2 from the PE hard capsule and salmeterol xinafoate delivered
      by Serevent® Diskus®, and to compare the safety of the two pharmaceutical forms.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: Change in area under the curve for the time period 0 to 12 hours (AUC0-12h) of the forced expiratory volume in one second (FEV1)
time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, and 12 hours post-dosing
measure: Change in peak FEV1
time frame: within 3 hours post-dosing
description: Peak FEV1 is defined as the maximum FEV1 obtained within the first three hours post dosing
measure: Change in FEV1 AUC12-24h
time frame: 12, 14, 22, 23 and 24 hours post-dosing
measure: Change in FEV1 AUC0-24h
time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
measure: Individual FEV1 measurements at each time point
time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
measure: Change in forced vital capacity (FVC) AUC0-12h
time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, and 12 hours post-dosing
measure: Change in peak FVC
time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
measure: Change in FVC AUC12-24h
time frame: 12, 14, 22, 23 and 24 hours post-dosing
measure: Change in FVC AUC0-24h
time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
measure: Individual FVC measurements at each time point
time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
measure: Number of patients with adverse events
time frame: up to 23 days
measure: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
measure: AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2; a time interval from 0 - 8 h is appropriate)
time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
measure: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
measure: Cmax (maximum measured concentration of the analyte in plasma)
time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
measure: tmax (time from dosing to the maximum concentration of the analyte in plasma)
time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
measure: λz (terminal rate constant in plasma)
time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
measure: t½ (terminal half-life of the analyte in plasma)
time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
measure: MRTih (mean residence time of the analyte in the body after inhalational administration)
time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
measure: CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
measure: Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
measure: Aet1-t2 (amount of analyte that is eliminated in urine from the time interval t1 to t2)
time frame: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
measure: fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
time frame: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
measure: CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
time frame: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
arm group label: Salmeterol xinafoate
arm group type: Experimental
description: 25 μg Salmeterol inhalation powder administered via HandiHaler®
arm group label: Serevent® Diskus®
arm group type: Active Comparator
description: 50 μg Salmeterol (dry powder inhaler) administered via Diskus®
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Salmeterol xinafoate
arm group label: Salmeterol xinafoate
intervention type: Drug
intervention name: Serevent® Diskus®
arm group label: Serevent® Diskus®
intervention type: Drug
intervention name: Placebo (HandiHaler®)
arm group label: Placebo
arm group label: Serevent® Diskus®
intervention type: Drug
intervention name: Placebo (Diskus®)
arm group label: Placebo
arm group label: Salmeterol xinafoate
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
mesh term: Salmeterol Xinafoate