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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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
Experimental: COMBIVENT Respimat 20/100 mcg -

Experimental: COMBIVENT CFC-MDI 36/206 mcg -

Experimental: Ipratropium Respimat 20 mcg -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
FEV1 AUC0-6 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
Timepoint [54] 0 0
During the 12-week on-treatment period
Secondary outcome [55] 0 0
COPD Exacerbation Rate During the On-treatment Period
Timepoint [55] 0 0
During the 12-week on-treatment period
Secondary outcome [56] 0 0
COPD Exacerbation During the On-treatment Period
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
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
Timepoint [59] 0 0
12 weeks
Secondary outcome [60] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left
Timepoint [60] 0 0
12 weeks
Secondary outcome [61] 0 0
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably
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
Timepoint [62] 0 0
12 weeks
Secondary outcome [63] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use
Timepoint [63] 0 0
12 weeks
Secondary outcome [64] 0 0
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable
Timepoint [64] 0 0
12 weeks
Secondary outcome [65] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler
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
Timepoint [66] 0 0
12 weeks
Secondary outcome [67] 0 0
Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler
Timepoint [67] 0 0
12 weeks
Secondary outcome [68] 0 0
Device Preference (Respimat or MDI)
Timepoint [68] 0 0
12 weeks
Secondary outcome [69] 0 0
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
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
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
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
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
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
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
Sex
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
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
1480
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
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Rhode Island
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
West Virginia
Country [32] 0 0
Argentina
State/province [32] 0 0
Capital Federal
Country [33] 0 0
Argentina
State/province [33] 0 0
La Plata
Country [34] 0 0
Argentina
State/province [34] 0 0
Lanús
Country [35] 0 0
Argentina
State/province [35] 0 0
Mar del Plata
Country [36] 0 0
Argentina
State/province [36] 0 0
Mendoza
Country [37] 0 0
Argentina
State/province [37] 0 0
Monte Grande
Country [38] 0 0
Argentina
State/province [38] 0 0
Paraná
Country [39] 0 0
Argentina
State/province [39] 0 0
Rosario
Country [40] 0 0
Argentina
State/province [40] 0 0
San Miguel de Tucumán
Country [41] 0 0
France
State/province [41] 0 0
Béthune
Country [42] 0 0
France
State/province [42] 0 0
Lille Cedex
Country [43] 0 0
France
State/province [43] 0 0
Marseille
Country [44] 0 0
France
State/province [44] 0 0
Nantes
Country [45] 0 0
France
State/province [45] 0 0
Nice
Country [46] 0 0
Greece
State/province [46] 0 0
Athens
Country [47] 0 0
Greece
State/province [47] 0 0
Heraklion
Country [48] 0 0
Greece
State/province [48] 0 0
Komotini
Country [49] 0 0
Greece
State/province [49] 0 0
Korinthos
Country [50] 0 0
Greece
State/province [50] 0 0
Larissa
Country [51] 0 0
Greece
State/province [51] 0 0
Nafplio
Country [52] 0 0
Greece
State/province [52] 0 0
Thessaloniki
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Daegu
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Geonggi-Do
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Gyeonggi-Do
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul
Country [57] 0 0
New Zealand
State/province [57] 0 0
Dunedin
Country [58] 0 0
New Zealand
State/province [58] 0 0
Grafton / Auckland
Country [59] 0 0
New Zealand
State/province [59] 0 0
Hamilton
Country [60] 0 0
New Zealand
State/province [60] 0 0
Tauranga
Country [61] 0 0
New Zealand
State/province [61] 0 0
Wellington
Country [62] 0 0
Poland
State/province [62] 0 0
Bydgoszcz
Country [63] 0 0
Poland
State/province [63] 0 0
Krakow
Country [64] 0 0
Poland
State/province [64] 0 0
Ostrow Wielkopolska
Country [65] 0 0
Poland
State/province [65] 0 0
Poznan
Country [66] 0 0
Poland
State/province [66] 0 0
Proszowice
Country [67] 0 0
Poland
State/province [67] 0 0
Radom
Country [68] 0 0
Poland
State/province [68] 0 0
Warsaw
Country [69] 0 0
Poland
State/province [69] 0 0
Wroclaw
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Kazan
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Moscow
Country [72] 0 0
Russian Federation
State/province [72] 0 0
St. Petersburg
Country [73] 0 0
Russian Federation
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St.Petersburg
Country [74] 0 0
South Africa
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Bellville
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South Africa
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Boksburg
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South Africa
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Cape Town
Country [77] 0 0
South Africa
State/province [77] 0 0
Johannesburg
Country [78] 0 0
South Africa
State/province [78] 0 0
Orange Grove
Country [79] 0 0
South Africa
State/province [79] 0 0
Paarl
Country [80] 0 0
South Africa
State/province [80] 0 0
Park Town West
Country [81] 0 0
Taiwan
State/province [81] 0 0
Keelong Town
Country [82] 0 0
Taiwan
State/province [82] 0 0
Taichung
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taipei
Country [84] 0 0
Taiwan
State/province [84] 0 0
Taoyuan
Country [85] 0 0
Turkey
State/province [85] 0 0
Ankara
Country [86] 0 0
Turkey
State/province [86] 0 0
Antalya
Country [87] 0 0
Turkey
State/province [87] 0 0
Istanbul
Country [88] 0 0
Turkey
State/province [88] 0 0
Mersin
Country [89] 0 0
Ukraine
State/province [89] 0 0
Dnyepropyetrovsk
Country [90] 0 0
Ukraine
State/province [90] 0 0
Donetsk
Country [91] 0 0
Ukraine
State/province [91] 0 0
Kiev
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Ballieston, Glasgow
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Bury St Edmonds
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Cambridge
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Colchester
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Doncaster
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Manchester
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Soham
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Swansea
Country [100] 0 0
United Kingdom
State/province [100] 0 0
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/study/NCT00400153
Trial related presentations / publications
Zuwallack R, De Salvo MC, Kaelin T, Bateman ED, Park CS, Abrahams R, Fakih F, Sachs P, Pudi K, Zhao Y, Wood CC; Combivent Respimat Inhaler Study Group. Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. Respir Med. 2010 Aug;104(8):1179-88. doi: 10.1016/j.rmed.2010.01.017. Epub 2010 Feb 20.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00400153