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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00400153




Registration number
NCT00400153
Ethics application status
Date submitted
15/11/2006
Date registered
15/11/2006
Date last updated
9/06/2014

Titles & IDs
Public title
Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)
Secondary ID [1] 0 0
1012.56
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
FEV1 AUC0-6 at 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
Timepoint [1] 0 0
Before drug administration to 6 hours after drug administration on Day 85
Primary outcome [2] 0 0
FEV1 AUC0-4 at 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
Timepoint [2] 0 0
Before drug administration to 4 hours after drug administration on Day 85
Primary outcome [3] 0 0
FEV1 AUC4-6 at 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
Timepoint [3] 0 0
Between 4 hours and 6 hours after drug administration on Day 85
Secondary outcome [1] 0 0
FEV1 AUC0-6 at 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
Timepoint [1] 0 0
Before drug administration to 6 hours after drug administration on Day 1
Secondary outcome [2] 0 0
FEV1 AUC0-6 at 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
Timepoint [2] 0 0
Before drug administration to 6 hours after drug administration on Day 29
Secondary outcome [3] 0 0
FEV1 AUC0-6 at 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
Timepoint [3] 0 0
Before drug administration to 6 hours after drug administration on Day 57
Secondary outcome [4] 0 0
FEV1 AUC0-4 at 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
Timepoint [4] 0 0
Before drug administration to 4 hours after drug administration on Day 1
Secondary outcome [5] 0 0
FEV1 AUC0-4 at 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
Timepoint [5] 0 0
Before drug administration to 4 hours after drug administration on Day 29
Secondary outcome [6] 0 0
FEV1 AUC0-4 at 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
Timepoint [6] 0 0
Before drug administration to 4 hours after drug administration on Day 57
Secondary outcome [7] 0 0
FEV1 AUC4-6 at 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
Timepoint [7] 0 0
Between 4 hours and 6 hours after drug administration on Day 1
Secondary outcome [8] 0 0
FEV1 AUC4-6 at 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
Timepoint [8] 0 0
Between 4 hours and 6 hours after drug administration on Day 29
Secondary outcome [9] 0 0
FEV1 AUC4-6 at 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
Timepoint [9] 0 0
Between 4 hours and 6 hours after drug administration on Day 57
Secondary outcome [10] 0 0
Peak FEV1 Response at 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
Timepoint [10] 0 0
Within the first 2-hour post-treatment interval on Day 1
Secondary outcome [11] 0 0
Peak FEV1 Response at 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
Timepoint [11] 0 0
Within the first 2-hour post-treatment interval on Day 29
Secondary outcome [12] 0 0
Peak FEV1 Response at 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
Timepoint [12] 0 0
Within the first 2-hour post-treatment interval on Day 57
Secondary outcome [13] 0 0
Peak FEV1 Response at 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
Timepoint [13] 0 0
Within the first 2-hour post-treatment interval on Day 85
Secondary outcome [14] 0 0
Time to Onset of Therapeutic FEV1 Response 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
Timepoint [14] 0 0
Within the first 2-hour post-treatment interval at Day 1
Secondary outcome [15] 0 0
Time to Onset of Therapeutic FEV1 Response 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
Timepoint [15] 0 0
Within the first 2-hour post-treatment interval at Day 29
Secondary outcome [16] 0 0
Time to Onset of Therapeutic FEV1 Response 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
Timepoint [16] 0 0
Within the first 2-hour post-treatment interval at Day 57
Secondary outcome [17] 0 0
Time to Onset of Therapeutic FEV1 Response 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
Timepoint [17] 0 0
Within the first 2-hour post-treatment interval at Day 85
Secondary outcome [18] 0 0
Duration of Therapeutic FEV1 Response 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
Timepoint [18] 0 0
During the 6-hour observation period after drug administration at Day 1
Secondary outcome [19] 0 0
Duration of Therapeutic FEV1 Response 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
Timepoint [19] 0 0
During the 6-hour observation period after drug administration at Day 29
Secondary outcome [20] 0 0
Duration of Therapeutic FEV1 Response 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
Timepoint [20] 0 0
During the 6-hour observation period after drug administration at Day 57
Secondary outcome [21] 0 0
Duration of Therapeutic FEV1 Response 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
Timepoint [21] 0 0
During the 6-hour observation period after drug administration at Day 85
Secondary outcome [22] 0 0
Time to Peak FEV1 Response 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
Timepoint [22] 0 0
Within the 6-hour post-treatment observation period at Day 1
Secondary outcome [23] 0 0
Time to Peak FEV1 Response 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
Timepoint [23] 0 0
Within the 6-hour post-treatment observation period at Day 29
Secondary outcome [24] 0 0
Time to Peak FEV1 Response 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
Timepoint [24] 0 0
Within the 6-hour post-treatment observation period at Day 57
Secondary outcome [25] 0 0
Time to Peak FEV1 Response 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
Timepoint [25] 0 0
Within the 6-hour post-treatment observation period at Day 85
Secondary outcome [26] 0 0
FVC AUC0-6 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
Timepoint [26] 0 0
Before drug administration to 6 hours after drug administration at Day 1
Secondary outcome [27] 0 0
FVC AUC0-6 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
Timepoint [27] 0 0
Before drug administration to 6 hours after drug administration at Day 29
Secondary outcome [28] 0 0
FVC AUC0-6 at 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
Timepoint [28] 0 0
Before drug administration to 6 hours after drug administration on Day 57
Secondary outcome [29] 0 0
FVC AUC0-6 at 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
Timepoint [29] 0 0
Before drug administration to 6 hours after drug administration on Day 85
Secondary outcome [30] 0 0
FVC AUC0-4 at 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
Timepoint [30] 0 0
Before drug administration to 4 hours after drug administration on Day 1
Secondary outcome [31] 0 0
FVC AUC0-4 at 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
Timepoint [31] 0 0
Before drug administration to 4 hours after drug administration on Day 29
Secondary outcome [32] 0 0
FVC AUC0-4 at 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
Timepoint [32] 0 0
Before drug administration to 4 hours after drug administration on Day 57
Secondary outcome [33] 0 0
FVC AUC0-4 at 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
Timepoint [33] 0 0
Before drug administration to 4 hours after drug administration on Day 85
Secondary outcome [34] 0 0
FVC AUC4-6 at 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
Timepoint [34] 0 0
Between 4 hours and 6 hours after drug administration on Day 1
Secondary outcome [35] 0 0
FVC AUC4-6 at 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
Timepoint [35] 0 0
Between 4 hours and 6 hours after drug administration on Day 29
Secondary outcome [36] 0 0
FVC AUC4-6 at 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
Timepoint [36] 0 0
Between 4 hours and 6 hours after drug administration on Day 57
Secondary outcome [37] 0 0
FVC AUC4-6 at 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
Timepoint [37] 0 0
Between 4 hours and 6 hours after drug administration on Day 85
Secondary outcome [38] 0 0
Peak FVC Response 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
Timepoint [38] 0 0
Within the first 2-hour post-treatment interval at Day 1
Secondary outcome [39] 0 0
Peak FVC Response 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
Timepoint [39] 0 0
Within the first 2-hour post-treatment interval at Day 29
Secondary outcome [40] 0 0
Peak FVC Response 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
Timepoint [40] 0 0
Within the first 2-hour post-treatment interval at Day 57
Secondary outcome [41] 0 0
Peak FVC Response 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
Timepoint [41] 0 0
Within the first 2-hour post-treatment interval at Day 85
Secondary outcome [42] 0 0
Rescue Medication Use on Pulmonary Test Day 1 - Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1
Timepoint [42] 0 0
During the 6-hour pulmonary function testing after drug administration on Day 1
Secondary outcome [43] 0 0
Rescue Medication Use on Pulmonary Test Day 29 - Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29
Timepoint [43] 0 0
During the 6-hour pulmonary function testing after drug administration on Day 29
Secondary outcome [44] 0 0
Rescue Medication Use on Pulmonary Test Day 57 - Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57
Timepoint [44] 0 0
During the 6-hour pulmonary function testing after drug administration on Day 57
Secondary outcome [45] 0 0
Rescue Medication Use on Pulmonary Test Day 85 - Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85
Timepoint [45] 0 0
During the 6-hour pulmonary function testing after drug administration on Day 85
Secondary outcome [46] 0 0
Night-time Rescue Medication Use - 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)
Timepoint [46] 0 0
During the 2-week baseline washout period and the 12-week treatment period
Secondary outcome [47] 0 0
Daytime Rescue Medication Use - The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)
Timepoint [47] 0 0
During the 2-week baseline washout period and the 12-week treatment period
Secondary outcome [48] 0 0
Night-time Symptom Score - 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
Timepoint [48] 0 0
During the 2-week baseline washout period and the 12-week treatment period
Secondary outcome [49] 0 0
Daytime Symptom Score - 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
Timepoint [49] 0 0
During the 2-week baseline washout period and the 12-week treatment period
Secondary outcome [50] 0 0
Trough Peak Expiratory Flow Rate (PEFR) - The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
Timepoint [50] 0 0
During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication
Secondary outcome [51] 0 0
Physician's Global Evaluation Score on Pulmonary Function Testing 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.
Timepoint [51] 0 0
Prior to pulmonary function test on Day 29
Secondary outcome [52] 0 0
Physician's Global Evaluation Score on Pulmonary Function Testing 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.
Timepoint [52] 0 0
Prior to pulmonary function test on Day 57
Secondary outcome [53] 0 0
Physician's Global Evaluation Score on Pulmonary Function Testing 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.
Timepoint [53] 0 0
Prior to pulmonary function test on Day 85
Secondary outcome [54] 0 0
Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the 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.
Timepoint [54] 0 0
During the 12-week on-treatment period
Secondary outcome [55] 0 0
COPD Exacerbation Rate During the 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.
Timepoint [55] 0 0
During the 12-week on-treatment period
Secondary outcome [56] 0 0
COPD Exacerbation During the 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.
Timepoint [56] 0 0
During the 12-week on-treatment period
Secondary outcome [57] 0 0
Frequency Distribution of Satisfaction Rating With Inhaler Attributes
Timepoint [57] 0 0
12 weeks
Secondary outcome [58] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine - 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.
Timepoint [58] 0 0
12 weeks
Secondary outcome [59] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung - 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.
Timepoint [59] 0 0
12 weeks
Secondary outcome [60] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left - 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.
Timepoint [60] 0 0
12 weeks
Secondary outcome [61] 0 0
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably - 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.
Timepoint [61] 0 0
12 weeks
Secondary outcome [62] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler - 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.
Timepoint [62] 0 0
12 weeks
Secondary outcome [63] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use - 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.
Timepoint [63] 0 0
12 weeks
Secondary outcome [64] 0 0
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable - 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.
Timepoint [64] 0 0
12 weeks
Secondary outcome [65] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler - 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.
Timepoint [65] 0 0
12 weeks
Secondary outcome [66] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler - 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.
Timepoint [66] 0 0
12 weeks
Secondary outcome [67] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler - 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.
Timepoint [67] 0 0
12 weeks
Secondary outcome [68] 0 0
Device Preference (Respimat or MDI) - Frequency of patients due to device preference
Timepoint [68] 0 0
12 weeks
Secondary outcome [69] 0 0
Rating of Action of Turning Clear Base of Respimat - Frequency of patients due to rating of action of turning clear base of Respimat
Timepoint [69] 0 0
12 weeks
Secondary outcome [70] 0 0
Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State - 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).
Timepoint [70] 0 0
Before drug administration to 6 hours after drug administration on Day 29
Secondary outcome [71] 0 0
Noncompartmental Parameters of Albuterol at Steady State - 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).
Timepoint [71] 0 0
Before drug administration to 6 hours after drug administration on Day 29
Secondary outcome [72] 0 0
Cumulative Amounts of Ipratropium [µg] Excreted in Urine for 0-2 Hours - Cumulative amounts of Ipratropium [µg] excreted in urine - Planned time intervals 0-2, ss
Timepoint [72] 0 0
Before drug administration to 2 hours after drug administration on Day 29
Secondary outcome [73] 0 0
Cumulative Amounts of Albuterol [µg] Excreted in Urine for 0-2 Hours - Cumulative amounts of Albuterol [µg] excreted in urine - Planned time intervals 0-2,ss.
Timepoint [73] 0 0
Before drug administration to 2 hours after drug administration on Day 29
Secondary outcome [74] 0 0
Cumulative Amounts of Ipratropium [µg] Excreted in Urine for 0-6 Hours - Cumulative amounts of Ipratropium [µg] excreted in urine - Planned time intervals 0-6,ss
Timepoint [74] 0 0
Before drug administration to 6 hours after drug administration on Day 26
Secondary outcome [75] 0 0
Cumulative Amounts of Albuterol [µg] Excreted in Urine for 0-6 Hours - Cumulative amounts of Albuterol [µg] excreted in urine - Planned time intervals 0-6, ss
Timepoint [75] 0 0
Before drug administration to 6 hours after drug administration on Day 29

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%).
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
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Windsor

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00400153
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Other publications