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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00400153
Registration number
NCT00400153
Ethics application status
Date submitted
15/11/2006
Date registered
16/11/2006
Date last updated
13/06/2014
Titles & IDs
Public title
Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
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Scientific title
Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)
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Secondary ID [1]
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1012.56
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atrovent Respimat (20 mcg)
Treatment: Drugs - COMBIVENT MDI (36/206 mcg)
Treatment: Drugs - Combivent Respimat (20 mcg/100 mcg)
Treatment: Drugs - Placebo via corresponding inhaler for blinding purposes
Experimental: COMBIVENT Respimat 20/100 mcg -
Experimental: COMBIVENT CFC-MDI 36/206 mcg -
Experimental: Ipratropium Respimat 20 mcg -
Treatment: Drugs: Atrovent Respimat (20 mcg)
Treatment: Drugs: COMBIVENT MDI (36/206 mcg)
Treatment: Drugs: Combivent Respimat (20 mcg/100 mcg)
Treatment: Drugs: Placebo via corresponding inhaler for blinding purposes
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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FEV1 AUC0-6 at Day 85
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Assessment method [1]
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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
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Timepoint [1]
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Before drug administration to 6 hours after drug administration on Day 85
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Primary outcome [2]
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FEV1 AUC0-4 at Day 85
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Assessment method [2]
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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
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Timepoint [2]
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Before drug administration to 4 hours after drug administration on Day 85
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Primary outcome [3]
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FEV1 AUC4-6 at Day 85
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Assessment method [3]
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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
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Timepoint [3]
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Between 4 hours and 6 hours after drug administration on Day 85
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Secondary outcome [1]
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FEV1 AUC0-6 at Day 1
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Assessment method [1]
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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
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Timepoint [1]
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Before drug administration to 6 hours after drug administration on Day 1
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Secondary outcome [2]
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FEV1 AUC0-6 at Day 29
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Assessment method [2]
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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
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Timepoint [2]
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Before drug administration to 6 hours after drug administration on Day 29
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Secondary outcome [3]
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FEV1 AUC0-6 at Day 57
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Assessment method [3]
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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
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Timepoint [3]
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Before drug administration to 6 hours after drug administration on Day 57
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Secondary outcome [4]
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FEV1 AUC0-4 at Day 1
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Assessment method [4]
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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
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Timepoint [4]
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Before drug administration to 4 hours after drug administration on Day 1
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Secondary outcome [5]
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FEV1 AUC0-4 at Day 29
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Assessment method [5]
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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
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Timepoint [5]
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Before drug administration to 4 hours after drug administration on Day 29
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Secondary outcome [6]
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FEV1 AUC0-4 at Day 57
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Assessment method [6]
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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
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Timepoint [6]
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Before drug administration to 4 hours after drug administration on Day 57
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Secondary outcome [7]
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FEV1 AUC4-6 at Day 1
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Assessment method [7]
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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
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Timepoint [7]
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Between 4 hours and 6 hours after drug administration on Day 1
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Secondary outcome [8]
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FEV1 AUC4-6 at Day 29
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Assessment method [8]
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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
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Timepoint [8]
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Between 4 hours and 6 hours after drug administration on Day 29
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Secondary outcome [9]
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FEV1 AUC4-6 at Day 57
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Assessment method [9]
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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
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Timepoint [9]
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Between 4 hours and 6 hours after drug administration on Day 57
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Secondary outcome [10]
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Peak FEV1 Response at Day 1
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Assessment method [10]
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Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
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Timepoint [10]
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Within the first 2-hour post-treatment interval on Day 1
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Secondary outcome [11]
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Peak FEV1 Response at Day 29
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Assessment method [11]
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Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
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Timepoint [11]
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Within the first 2-hour post-treatment interval on Day 29
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Secondary outcome [12]
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Peak FEV1 Response at Day 57
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Assessment method [12]
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Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
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Timepoint [12]
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Within the first 2-hour post-treatment interval on Day 57
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Secondary outcome [13]
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Peak FEV1 Response at Day 85
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Assessment method [13]
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Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
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Timepoint [13]
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Within the first 2-hour post-treatment interval on Day 85
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Secondary outcome [14]
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Time to Onset of Therapeutic FEV1 Response at Day 1
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Assessment method [14]
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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
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Timepoint [14]
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Within the first 2-hour post-treatment interval at Day 1
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Secondary outcome [15]
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Time to Onset of Therapeutic FEV1 Response at Day 29
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Assessment method [15]
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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
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Timepoint [15]
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Within the first 2-hour post-treatment interval at Day 29
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Secondary outcome [16]
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Time to Onset of Therapeutic FEV1 Response at Day 57
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Assessment method [16]
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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
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Timepoint [16]
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Within the first 2-hour post-treatment interval at Day 57
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Secondary outcome [17]
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Time to Onset of Therapeutic FEV1 Response at Day 85
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Assessment method [17]
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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
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Timepoint [17]
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Within the first 2-hour post-treatment interval at Day 85
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Secondary outcome [18]
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Duration of Therapeutic FEV1 Response at Day 1
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Assessment method [18]
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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
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Timepoint [18]
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During the 6-hour observation period after drug administration at Day 1
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Secondary outcome [19]
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Duration of Therapeutic FEV1 Response at Day 29
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Assessment method [19]
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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
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Timepoint [19]
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During the 6-hour observation period after drug administration at Day 29
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Secondary outcome [20]
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Duration of Therapeutic FEV1 Response at Day 57
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Assessment method [20]
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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
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Timepoint [20]
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During the 6-hour observation period after drug administration at Day 57
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Secondary outcome [21]
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Duration of Therapeutic FEV1 Response at Day 85
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Assessment method [21]
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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
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Timepoint [21]
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During the 6-hour observation period after drug administration at Day 85
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Secondary outcome [22]
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Time to Peak FEV1 Response at Day 1
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Assessment method [22]
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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
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Timepoint [22]
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Within the 6-hour post-treatment observation period at Day 1
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Secondary outcome [23]
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0
Time to Peak FEV1 Response at Day 29
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Assessment method [23]
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0
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
Query!
Timepoint [23]
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Within the 6-hour post-treatment observation period at Day 29
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Secondary outcome [24]
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0
Time to Peak FEV1 Response at Day 57
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Assessment method [24]
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0
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
Query!
Timepoint [24]
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Within the 6-hour post-treatment observation period at Day 57
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Secondary outcome [25]
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0
Time to Peak FEV1 Response at Day 85
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Assessment method [25]
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0
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
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Timepoint [25]
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Within the 6-hour post-treatment observation period at Day 85
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Secondary outcome [26]
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FVC AUC0-6 at Day 1
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Assessment method [26]
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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
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Timepoint [26]
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Before drug administration to 6 hours after drug administration at Day 1
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Secondary outcome [27]
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FVC AUC0-6 at Day 29
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Assessment method [27]
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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
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Timepoint [27]
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Before drug administration to 6 hours after drug administration at Day 29
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Secondary outcome [28]
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FVC AUC0-6 at Day 57
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Assessment method [28]
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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
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Timepoint [28]
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Before drug administration to 6 hours after drug administration on Day 57
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Secondary outcome [29]
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FVC AUC0-6 at Day 85
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Assessment method [29]
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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
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Timepoint [29]
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Before drug administration to 6 hours after drug administration on Day 85
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Secondary outcome [30]
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FVC AUC0-4 at Day 1
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Assessment method [30]
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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
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Timepoint [30]
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Before drug administration to 4 hours after drug administration on Day 1
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Secondary outcome [31]
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FVC AUC0-4 at Day 29
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Assessment method [31]
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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
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Timepoint [31]
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Before drug administration to 4 hours after drug administration on Day 29
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Secondary outcome [32]
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0
FVC AUC0-4 at Day 57
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Assessment method [32]
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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
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Timepoint [32]
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Before drug administration to 4 hours after drug administration on Day 57
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Secondary outcome [33]
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FVC AUC0-4 at Day 85
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Assessment method [33]
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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
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Timepoint [33]
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Before drug administration to 4 hours after drug administration on Day 85
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Secondary outcome [34]
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FVC AUC4-6 at Day 1
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Assessment method [34]
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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
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Timepoint [34]
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Between 4 hours and 6 hours after drug administration on Day 1
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Secondary outcome [35]
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0
FVC AUC4-6 at Day 29
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Assessment method [35]
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0
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
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Timepoint [35]
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Between 4 hours and 6 hours after drug administration on Day 29
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Secondary outcome [36]
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0
FVC AUC4-6 at Day 57
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Assessment method [36]
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0
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
Query!
Timepoint [36]
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Between 4 hours and 6 hours after drug administration on Day 57
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Secondary outcome [37]
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0
FVC AUC4-6 at Day 85
Query!
Assessment method [37]
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0
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
Query!
Timepoint [37]
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Between 4 hours and 6 hours after drug administration on Day 85
Query!
Secondary outcome [38]
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0
Peak FVC Response at Day 1
Query!
Assessment method [38]
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0
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
Query!
Timepoint [38]
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Within the first 2-hour post-treatment interval at Day 1
Query!
Secondary outcome [39]
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0
Peak FVC Response at Day 29
Query!
Assessment method [39]
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0
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
Query!
Timepoint [39]
0
0
Within the first 2-hour post-treatment interval at Day 29
Query!
Secondary outcome [40]
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0
Peak FVC Response at Day 57
Query!
Assessment method [40]
0
0
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
Query!
Timepoint [40]
0
0
Within the first 2-hour post-treatment interval at Day 57
Query!
Secondary outcome [41]
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0
Peak FVC Response at Day 85
Query!
Assessment method [41]
0
0
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
Query!
Timepoint [41]
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Within the first 2-hour post-treatment interval at Day 85
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Secondary outcome [42]
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Rescue Medication Use on Pulmonary Test Day 1
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Assessment method [42]
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Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1
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Timepoint [42]
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During the 6-hour pulmonary function testing after drug administration on Day 1
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Secondary outcome [43]
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Rescue Medication Use on Pulmonary Test Day 29
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Assessment method [43]
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Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29
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Timepoint [43]
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During the 6-hour pulmonary function testing after drug administration on Day 29
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Secondary outcome [44]
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Rescue Medication Use on Pulmonary Test Day 57
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Assessment method [44]
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Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57
Query!
Timepoint [44]
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During the 6-hour pulmonary function testing after drug administration on Day 57
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Secondary outcome [45]
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Rescue Medication Use on Pulmonary Test Day 85
Query!
Assessment method [45]
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0
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85
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Timepoint [45]
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During the 6-hour pulmonary function testing after drug administration on Day 85
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Secondary outcome [46]
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Night-time Rescue Medication Use
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Assessment method [46]
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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)
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Timepoint [46]
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During the 2-week baseline washout period and the 12-week treatment period
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Secondary outcome [47]
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Daytime Rescue Medication Use
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Assessment method [47]
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0
The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)
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Timepoint [47]
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During the 2-week baseline washout period and the 12-week treatment period
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Secondary outcome [48]
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Night-time Symptom Score
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Assessment method [48]
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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
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Timepoint [48]
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During the 2-week baseline washout period and the 12-week treatment period
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Secondary outcome [49]
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Daytime Symptom Score
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Assessment method [49]
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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
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Timepoint [49]
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0
During the 2-week baseline washout period and the 12-week treatment period
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Secondary outcome [50]
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0
Trough Peak Expiratory Flow Rate (PEFR)
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Assessment method [50]
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0
The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
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Timepoint [50]
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0
During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication
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Secondary outcome [51]
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0
Physician's Global Evaluation Score on Pulmonary Function Testing Day 29
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Assessment method [51]
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0
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.
Query!
Timepoint [51]
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0
Prior to pulmonary function test on Day 29
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Secondary outcome [52]
0
0
Physician's Global Evaluation Score on Pulmonary Function Testing Day 57
Query!
Assessment method [52]
0
0
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.
Query!
Timepoint [52]
0
0
Prior to pulmonary function test on Day 57
Query!
Secondary outcome [53]
0
0
Physician's Global Evaluation Score on Pulmonary Function Testing Day 85
Query!
Assessment method [53]
0
0
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.
Query!
Timepoint [53]
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0
Prior to pulmonary function test on Day 85
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Secondary outcome [54]
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0
Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period
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Assessment method [54]
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0
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.
Query!
Timepoint [54]
0
0
During the 12-week on-treatment period
Query!
Secondary outcome [55]
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0
COPD Exacerbation Rate During the On-treatment Period
Query!
Assessment method [55]
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0
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.
Query!
Timepoint [55]
0
0
During the 12-week on-treatment period
Query!
Secondary outcome [56]
0
0
COPD Exacerbation During the On-treatment Period
Query!
Assessment method [56]
0
0
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.
Query!
Timepoint [56]
0
0
During the 12-week on-treatment period
Query!
Secondary outcome [57]
0
0
Frequency Distribution of Satisfaction Rating With Inhaler Attributes
Query!
Assessment method [57]
0
0
Query!
Timepoint [57]
0
0
12 weeks
Query!
Secondary outcome [58]
0
0
Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine
Query!
Assessment method [58]
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0
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.
Query!
Timepoint [58]
0
0
12 weeks
Query!
Secondary outcome [59]
0
0
Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung
Query!
Assessment method [59]
0
0
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.
Query!
Timepoint [59]
0
0
12 weeks
Query!
Secondary outcome [60]
0
0
Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left
Query!
Assessment method [60]
0
0
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.
Query!
Timepoint [60]
0
0
12 weeks
Query!
Secondary outcome [61]
0
0
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably
Query!
Assessment method [61]
0
0
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.
Query!
Timepoint [61]
0
0
12 weeks
Query!
Secondary outcome [62]
0
0
Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler
Query!
Assessment method [62]
0
0
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.
Query!
Timepoint [62]
0
0
12 weeks
Query!
Secondary outcome [63]
0
0
Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use
Query!
Assessment method [63]
0
0
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.
Query!
Timepoint [63]
0
0
12 weeks
Query!
Secondary outcome [64]
0
0
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable
Query!
Assessment method [64]
0
0
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.
Query!
Timepoint [64]
0
0
12 weeks
Query!
Secondary outcome [65]
0
0
Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler
Query!
Assessment method [65]
0
0
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.
Query!
Timepoint [65]
0
0
12 weeks
Query!
Secondary outcome [66]
0
0
Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler
Query!
Assessment method [66]
0
0
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.
Query!
Timepoint [66]
0
0
12 weeks
Query!
Secondary outcome [67]
0
0
Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler
Query!
Assessment method [67]
0
0
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.
Query!
Timepoint [67]
0
0
12 weeks
Query!
Secondary outcome [68]
0
0
Device Preference (Respimat or MDI)
Query!
Assessment method [68]
0
0
Frequency of patients due to device preference
Query!
Timepoint [68]
0
0
12 weeks
Query!
Secondary outcome [69]
0
0
Rating of Action of Turning Clear Base of Respimat
Query!
Assessment method [69]
0
0
Frequency of patients due to rating of action of turning clear base of Respimat
Query!
Timepoint [69]
0
0
12 weeks
Query!
Secondary outcome [70]
0
0
Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State
Query!
Assessment method [70]
0
0
Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCt). 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).
Query!
Timepoint [70]
0
0
Before drug administration to 6 hours after drug administration on Day 29
Query!
Secondary outcome [71]
0
0
Noncompartmental Parameters of Albuterol at Steady State
Query!
Assessment method [71]
0
0
Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCt). 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).
Query!
Timepoint [71]
0
0
Before drug administration to 6 hours after drug administration on Day 29
Query!
Secondary outcome [72]
0
0
Cumulative Amounts of Ipratropium [µg] Excreted in Urine for 0-2 Hours
Query!
Assessment method [72]
0
0
Cumulative amounts of Ipratropium [µg] excreted in urine - Planned time intervals 0-2, ss
Query!
Timepoint [72]
0
0
Before drug administration to 2 hours after drug administration on Day 29
Query!
Secondary outcome [73]
0
0
Cumulative Amounts of Albuterol [µg] Excreted in Urine for 0-2 Hours
Query!
Assessment method [73]
0
0
Cumulative amounts of Albuterol [µg] excreted in urine - Planned time intervals 0-2,ss.
Query!
Timepoint [73]
0
0
Before drug administration to 2 hours after drug administration on Day 29
Query!
Secondary outcome [74]
0
0
Cumulative Amounts of Ipratropium [µg] Excreted in Urine for 0-6 Hours
Query!
Assessment method [74]
0
0
Cumulative amounts of Ipratropium [µg] excreted in urine - Planned time intervals 0-6,ss
Query!
Timepoint [74]
0
0
Before drug administration to 6 hours after drug administration on Day 26
Query!
Secondary outcome [75]
0
0
Cumulative Amounts of Albuterol [µg] Excreted in Urine for 0-6 Hours
Query!
Assessment method [75]
0
0
Cumulative amounts of Albuterol [µg] excreted in urine - Planned time intervals 0-6, ss
Query!
Timepoint [75]
0
0
Before drug administration to 6 hours after drug administration on Day 29
Query!
Eligibility
Key inclusion criteria
Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted
normal and FEV1/FVC 70%).
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1480
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Minnesota
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Mexico
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New York
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
North Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Ohio
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oklahoma
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oregon
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Pennsylvania
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Rhode Island
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
South Carolina
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Tennessee
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Texas
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Virginia
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Washington
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
West Virginia
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Capital Federal
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
La Plata
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Lanús
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Mar del Plata
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Mendoza
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Monte Grande
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
Paraná
Query!
Country [39]
0
0
Argentina
Query!
State/province [39]
0
0
Rosario
Query!
Country [40]
0
0
Argentina
Query!
State/province [40]
0
0
San Miguel de Tucumán
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Béthune
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Lille Cedex
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Marseille
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Nantes
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Nice
Query!
Country [46]
0
0
Greece
Query!
State/province [46]
0
0
Athens
Query!
Country [47]
0
0
Greece
Query!
State/province [47]
0
0
Heraklion
Query!
Country [48]
0
0
Greece
Query!
State/province [48]
0
0
Komotini
Query!
Country [49]
0
0
Greece
Query!
State/province [49]
0
0
Korinthos
Query!
Country [50]
0
0
Greece
Query!
State/province [50]
0
0
Larissa
Query!
Country [51]
0
0
Greece
Query!
State/province [51]
0
0
Nafplio
Query!
Country [52]
0
0
Greece
Query!
State/province [52]
0
0
Thessaloniki
Query!
Country [53]
0
0
Korea, Republic of
Query!
State/province [53]
0
0
Daegu
Query!
Country [54]
0
0
Korea, Republic of
Query!
State/province [54]
0
0
Geonggi-Do
Query!
Country [55]
0
0
Korea, Republic of
Query!
State/province [55]
0
0
Gyeonggi-Do
Query!
Country [56]
0
0
Korea, Republic of
Query!
State/province [56]
0
0
Seoul
Query!
Country [57]
0
0
New Zealand
Query!
State/province [57]
0
0
Dunedin
Query!
Country [58]
0
0
New Zealand
Query!
State/province [58]
0
0
Grafton / Auckland
Query!
Country [59]
0
0
New Zealand
Query!
State/province [59]
0
0
Hamilton
Query!
Country [60]
0
0
New Zealand
Query!
State/province [60]
0
0
Tauranga
Query!
Country [61]
0
0
New Zealand
Query!
State/province [61]
0
0
Wellington
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Bydgoszcz
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Krakow
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Ostrow Wielkopolska
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Poznan
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Proszowice
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Radom
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Warsaw
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Wroclaw
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Kazan
Query!
Country [71]
0
0
Russian Federation
Query!
State/province [71]
0
0
Moscow
Query!
Country [72]
0
0
Russian Federation
Query!
State/province [72]
0
0
St. Petersburg
Query!
Country [73]
0
0
Russian Federation
Query!
State/province [73]
0
0
St.Petersburg
Query!
Country [74]
0
0
South Africa
Query!
State/province [74]
0
0
Bellville
Query!
Country [75]
0
0
South Africa
Query!
State/province [75]
0
0
Boksburg
Query!
Country [76]
0
0
South Africa
Query!
State/province [76]
0
0
Cape Town
Query!
Country [77]
0
0
South Africa
Query!
State/province [77]
0
0
Johannesburg
Query!
Country [78]
0
0
South Africa
Query!
State/province [78]
0
0
Orange Grove
Query!
Country [79]
0
0
South Africa
Query!
State/province [79]
0
0
Paarl
Query!
Country [80]
0
0
South Africa
Query!
State/province [80]
0
0
Park Town West
Query!
Country [81]
0
0
Taiwan
Query!
State/province [81]
0
0
Keelong Town
Query!
Country [82]
0
0
Taiwan
Query!
State/province [82]
0
0
Taichung
Query!
Country [83]
0
0
Taiwan
Query!
State/province [83]
0
0
Taipei
Query!
Country [84]
0
0
Taiwan
Query!
State/province [84]
0
0
Taoyuan
Query!
Country [85]
0
0
Turkey
Query!
State/province [85]
0
0
Ankara
Query!
Country [86]
0
0
Turkey
Query!
State/province [86]
0
0
Antalya
Query!
Country [87]
0
0
Turkey
Query!
State/province [87]
0
0
Istanbul
Query!
Country [88]
0
0
Turkey
Query!
State/province [88]
0
0
Mersin
Query!
Country [89]
0
0
Ukraine
Query!
State/province [89]
0
0
Dnyepropyetrovsk
Query!
Country [90]
0
0
Ukraine
Query!
State/province [90]
0
0
Donetsk
Query!
Country [91]
0
0
Ukraine
Query!
State/province [91]
0
0
Kiev
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Ballieston, Glasgow
Query!
Country [93]
0
0
United Kingdom
Query!
State/province [93]
0
0
Bury St Edmonds
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Cambridge
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Colchester
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
Doncaster
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Manchester
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Soham
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Swansea
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Windsor
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00400153
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Boehringer Ingelheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00400153
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