Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00400153
Recruitment Status : Completed
First Posted : November 16, 2006
Results First Posted : June 1, 2009
Last Update Posted : June 13, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE November 15, 2006
First Posted Date  ICMJE November 16, 2006
Results First Submitted Date  ICMJE April 3, 2009
Results First Posted Date  ICMJE June 1, 2009
Last Update Posted Date June 13, 2014
Study Start Date  ICMJE November 2006
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2011)
  • FEV1 AUC0-6 at Day 85 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 85 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
  • FEV1 AUC0-4 at Day 85 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 85 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
  • FEV1 AUC4-6 at Day 85 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 85 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2006)
There are three co-primary endpoints: (1) FEV1 AUC (0-6) Combivent Respimat compared to COMBIVENT MDI (2) FEV1 AUC (0-4) Combivent Respimat compared to Atrovent Respimat (3) FEV1 AUC (4-6) Combivent Respimat compared to Atrovent Respimat
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2014)
  • FEV1 AUC0-6 at Day 1 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 1 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
  • FEV1 AUC0-6 at Day 29 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 29 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
  • FEV1 AUC0-6 at Day 57 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 57 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
  • FEV1 AUC0-4 at Day 1 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 1 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
  • FEV1 AUC0-4 at Day 29 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 29 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
  • FEV1 AUC0-4 at Day 57 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 57 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
  • FEV1 AUC4-6 at Day 1 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 1 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
  • FEV1 AUC4-6 at Day 29 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 29 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
  • FEV1 AUC4-6 at Day 57 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 57 ]
    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
  • Peak FEV1 Response at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval on Day 1 ]
    Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
  • Peak FEV1 Response at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval on Day 29 ]
    Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
  • Peak FEV1 Response at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval on Day 57 ]
    Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
  • Peak FEV1 Response at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval on Day 85 ]
    Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
  • Time to Onset of Therapeutic FEV1 Response at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval at Day 1 ]
    Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1
  • Time to Onset of Therapeutic FEV1 Response at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval at Day 29 ]
    Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29
  • Time to Onset of Therapeutic FEV1 Response at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval at Day 57 ]
    Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57
  • Time to Onset of Therapeutic FEV1 Response at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval at Day 85 ]
    Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85
  • Duration of Therapeutic FEV1 Response at Day 1 [ Time Frame: During the 6-hour observation period after drug administration at Day 1 ]
    The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1
  • Duration of Therapeutic FEV1 Response at Day 29 [ Time Frame: During the 6-hour observation period after drug administration at Day 29 ]
    The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29
  • Duration of Therapeutic FEV1 Response at Day 57 [ Time Frame: During the 6-hour observation period after drug administration at Day 57 ]
    The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57
  • Duration of Therapeutic FEV1 Response at Day 85 [ Time Frame: During the 6-hour observation period after drug administration at Day 85 ]
    The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85
  • Time to Peak FEV1 Response at Day 1 [ Time Frame: Within the 6-hour post-treatment observation period at Day 1 ]
    The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1
  • Time to Peak FEV1 Response at Day 29 [ Time Frame: Within the 6-hour post-treatment observation period at Day 29 ]
    The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29
  • Time to Peak FEV1 Response at Day 57 [ Time Frame: Within the 6-hour post-treatment observation period at Day 57 ]
    The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57
  • Time to Peak FEV1 Response at Day 85 [ Time Frame: Within the 6-hour post-treatment observation period at Day 85 ]
    The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85
  • FVC AUC0-6 at Day 1 [ Time Frame: Before drug administration to 6 hours after drug administration at Day 1 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
  • FVC AUC0-6 at Day 29 [ Time Frame: Before drug administration to 6 hours after drug administration at Day 29 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
  • FVC AUC0-6 at Day 57 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 57 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
  • FVC AUC0-6 at Day 85 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 85 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
  • FVC AUC0-4 at Day 1 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 1 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
  • FVC AUC0-4 at Day 29 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 29 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
  • FVC AUC0-4 at Day 57 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 57 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
  • FVC AUC0-4 at Day 85 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 85 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
  • FVC AUC4-6 at Day 1 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 1 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
  • FVC AUC4-6 at Day 29 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 29 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
  • FVC AUC4-6 at Day 57 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 57 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
  • FVC AUC4-6 at Day 85 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 85 ]
    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85
  • Peak FVC Response at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval at Day 1 ]
    Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
  • Peak FVC Response at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval at Day 29 ]
    Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
  • Peak FVC Response at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval at Day 57 ]
    Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
  • Peak FVC Response at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval at Day 85 ]
    Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
  • Rescue Medication Use on Pulmonary Test Day 1 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 1 ]
    Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1
  • Rescue Medication Use on Pulmonary Test Day 29 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 29 ]
    Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29
  • Rescue Medication Use on Pulmonary Test Day 57 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 57 ]
    Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57
  • Rescue Medication Use on Pulmonary Test Day 85 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 85 ]
    Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85
  • Night-time Rescue Medication Use [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
    The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)
  • Daytime Rescue Medication Use [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
    The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)
  • Night-time Symptom Score [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
    The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period). Night−time COPD symptoms: 0=none 1=some − slept well 2=woke once 3=woke several times 4=woke most of night
  • Daytime Symptom Score [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
    The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period). Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities
  • Trough Peak Expiratory Flow Rate (PEFR) [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]
    The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
  • Physician's Global Evaluation Score on Pulmonary Function Testing Day 29 [ Time Frame: Prior to pulmonary function test on Day 29 ]
    Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
  • Physician's Global Evaluation Score on Pulmonary Function Testing Day 57 [ Time Frame: Prior to pulmonary function test on Day 57 ]
    Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
  • Physician's Global Evaluation Score on Pulmonary Function Testing Day 85 [ Time Frame: Prior to pulmonary function test on Day 85 ]
    Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
  • Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period [ Time Frame: During the 12-week on-treatment period ]
    COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
  • COPD Exacerbation Rate During the On-treatment Period [ Time Frame: During the 12-week on-treatment period ]
    Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
  • COPD Exacerbation During the On-treatment Period [ Time Frame: During the 12-week on-treatment period ]
    COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
  • Frequency Distribution of Satisfaction Rating With Inhaler Attributes [ Time Frame: 12 weeks ]
  • Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine [ Time Frame: 12 weeks ]
    Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
  • Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung [ Time Frame: 12 weeks ]
    Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
  • Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left [ Time Frame: 12 weeks ]
    Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
  • Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably [ Time Frame: 12 weeks ]
    Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
  • Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler [ Time Frame: 12 weeks ]
    Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
  • Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use [ Time Frame: 12 weeks ]
    Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
  • Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable [ Time Frame: 12 weeks ]
    Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
  • Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler [ Time Frame: 12 weeks ]
    Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
  • Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler [ Time Frame: 12 weeks ]
    Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
  • Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler [ Time Frame: 12 weeks ]
    Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
  • Device Preference (Respimat or MDI) [ Time Frame: 12 weeks ]
    Frequency of patients due to device preference
  • Rating of Action of Turning Clear Base of Respimat [ Time Frame: 12 weeks ]
    Frequency of patients due to rating of action of turning clear base of Respimat
  • Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State [ Time Frame: Before drug administration to 6 hours after drug administration on Day 29 ]
    Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).
  • Noncompartmental Parameters of Albuterol at Steady State [ Time Frame: Before drug administration to 6 hours after drug administration on Day 29 ]
    Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).
  • Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours [ Time Frame: Before drug administration to 2 hours after drug administration on Day 29 ]
    Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss
  • Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours [ Time Frame: Before drug administration to 2 hours after drug administration on Day 29 ]
    Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0−2,ss.
  • Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours [ Time Frame: Before drug administration to 6 hours after drug administration on Day 26 ]
    Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0−6,ss
  • Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours [ Time Frame: Before drug administration to 6 hours after drug administration on Day 29 ]
    Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0−6, ss
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2006)
(1) AM Peak Flow, (2) Beta agonist and steroid use, (3) COPD Daily Symptom Scores, (4) Physician Global Assessment (PGA) and (5) COPD Exacerbations.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: Atrovent Respimat (20 mcg)
  • Drug: COMBIVENT MDI (36/206 mcg)
  • Drug: Combivent Respimat (20 mcg/100 mcg)
  • Drug: Placebo via corresponding inhaler for blinding purposes
Study Arms  ICMJE
  • Experimental: COMBIVENT Respimat 20/100 mcg
    Interventions:
    • Drug: Combivent Respimat (20 mcg/100 mcg)
    • Drug: Placebo via corresponding inhaler for blinding purposes
  • Experimental: COMBIVENT CFC-MDI 36/206 mcg
    Interventions:
    • Drug: COMBIVENT MDI (36/206 mcg)
    • Drug: Placebo via corresponding inhaler for blinding purposes
  • Experimental: Ipratropium Respimat 20 mcg
    Interventions:
    • Drug: Atrovent Respimat (20 mcg)
    • Drug: Placebo via corresponding inhaler for blinding purposes
Publications * Zuwallack R, De Salvo MC, Kaelin T, Bateman ED, Park CS, Abrahams R, Fakih F, Sachs P, Pudi K, Zhao Y, Wood CC; Combivent Respimat Inhaler Study Group. Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. Respir Med. 2010 Aug;104(8):1179-88. doi: 10.1016/j.rmed.2010.01.017. Epub 2010 Feb 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2008)
1480
Original Enrollment  ICMJE
 (submitted: November 15, 2006)
1440
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).

Exclusion Criteria:

Patients with significant diseases other than COPD that may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   France,   Greece,   Korea, Republic of,   New Zealand,   Poland,   Russian Federation,   South Africa,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Brazil
 
Administrative Information
NCT Number  ICMJE NCT00400153
Other Study ID Numbers  ICMJE 1012.56
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP