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

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00400153

First received: November 15, 2006

Last updated: June 9, 2014

Last verified: June 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	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	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

MedlinePlus related topics: COPD Lung Diseases

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:

FEV1 AUC0-6 at Day 85 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 85 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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

Secondary Outcome Measures:

FEV1 AUC0-6 at Day 1 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 1 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Frequency of patients due to device preference
Rating of Action of Turning Clear Base of Respimat [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0−6, ss


Enrollment:	1480
Study Start Date:	November 2006
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: COMBIVENT Respimat 20/100 mcg	Drug: Combivent Respimat (20 mcg/100 mcg) Drug: Placebo via corresponding inhaler for blinding purposes
Experimental: COMBIVENT CFC-MDI 36/206 mcg	Drug: COMBIVENT MDI (36/206 mcg) Drug: Placebo via corresponding inhaler for blinding purposes
Experimental: Ipratropium Respimat 20 mcg	Drug: Atrovent Respimat (20 mcg) Drug: Placebo via corresponding inhaler for blinding purposes

Eligibility


Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400153

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Sponsors and Collaborators

Boehringer Ingelheim

Investigators


Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00400153 History of Changes
Other Study ID Numbers:	1012.56
Study First Received:	November 15, 2006
Results First Received:	April 3, 2009
Last Updated:	June 9, 2014
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) New Zealand: Multicentre Ethics Committee/Medsafe United States: Food and Drug Administration France: AFSSAPS Greece: National Organization for Medicines (EOF) National Ethics Committee Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología) Taiwan: Department of Health, Executive Yuan, Taiwan Korea, Republic of: Korea Food and Drug Administration Turkey: Ministry of Health Central Ethics Committee Great Britain: MHRA South Africa: MCC (Medicines Control Council)

Additional relevant MeSH terms:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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