Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00400153

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) plus placebo COMBIVENT MDI Drug: COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat Drug: Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT	Phase III

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Combivent

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Area Between the Test-Day Baseline Forced Expiratory Volume in One Second (FEV1) and the FEV1 Change From the Test-Day Baseline Curve From 0 to 6 Hours Divided by 6 at Day 85 (FEV1 AUC0-6 at Day 85) [ Time Frame: Before drug administration to 6 hours after drug administration on Day 85 ]
FEV1 AUC0-4 at Day 85 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 85 ]
FEV1 AUC4-6 at Day 85 [ Time Frame: Between 4 hours and 6 hours after drug administration on 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 ]
FEV1 AUC0-6 at Day 29 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 29 ]
FEV1 AUC0-6 at Day 57 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 57 ]
FEV1 AUC0-4 at Day 1 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 1 ]
FEV1 AUC0-4 at Day 29 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 29 ]
FEV1 AUC0-4 at Day 57 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 57 ]
FEV1 AUC4-6 at Day 1 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 1 ]
FEV1 AUC4-6 at Day 29 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 29 ]
FEV1 AUC4-6 at Day 57 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 57 ]
Peak FEV1 Response at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval on Day 1 ]
Peak FEV1 Response at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval on Day 29 ]
Peak FEV1 Response at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval on Day 57 ]
Peak FEV1 Response at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval on Day 85 ]
Time to Onset of Therapeutic FEV1 Resposne at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval at Day 1 ]
Time to Onset of Therapeutic FEV1 Resposne at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval at Day 29 ]
Time to Onset of Therapeutic FEV1 Resposne at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval at Day 57 ]
Time to Onset of Therapeutic FEV1 Resposne at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval at Day 85 ]
Duration of Therapeutic FEV1 Resposne at Day 1 [ Time Frame: During the 6-hour observation period after drug administration at Day 1 ]
Duration of Therapeutic FEV1 Resposne at Day 29 [ Time Frame: During the 6-hour observation period after drug administration at Day 29 ]
Duration of Therapeutic FEV1 Resposne at Day 57 [ Time Frame: During the 6-hour observation period after drug administration at Day 57 ]
Duration of Therapeutic FEV1 Resposne at Day 85 [ Time Frame: During the 6-hour observation period after drug administration at Day 85 ]
Time to Peak FEV1 Resposne at Day 1 [ Time Frame: Within the 6-hour post-treatment observation period at Day 1 ]
Time to Peak FEV1 Resposne at Day 29 [ Time Frame: Within the 6-hour post-treatment observation period at Day 29 ]
Time to Peak FEV1 Resposne at Day 57 [ Time Frame: Within the 6-hour post-treatment observation period at Day 57 ]
Time to Peak FEV1 Resposne at Day 85 [ Time Frame: Within the 6-hour post-treatment observation period at Day 85 ]
FVC AUC0-6 at Day 1 [ Time Frame: Before drug administration to 6 hours after drug administration at Day 1 ]
FVC AUC0-6 at Day 29 [ Time Frame: Before drug administration to 6 hours after drug administration at Day 29 ]
FVC AUC0-6 at Day 57 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 57 ]
FVC AUC0-6 at Day 85 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 85 ]
FVC AUC0-4 at Day 1 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 1 ]
FVC AUC0-4 at Day 29 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 29 ]
FVC AUC0-4 at Day 57 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 57 ]
FVC AUC0-4 at Day 85 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 85 ]
FVC AUC4-6 at Day 1 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 1 ]
FVC AUC4-6 at Day 29 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 29 ]
FVC AUC4-6 at Day 57 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 57 ]
FVC AUC4-6 at Day 85 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 85 ]
Peak FVC Response at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval at Day 1 ]
Peak FVC Response at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval at Day 29 ]
Peak FVC Response at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval at Day 57 ]
Peak FVC Response at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval at 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 ]
Rescue Medication Use on Pulmonary Test Day 29 [ Time Frame: 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 ]
Rescue Medication Use on Pulmonary Test Day 85 [ Time Frame: 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 ]
Daytime Rescue Medication Use [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
Night-Time Symptom Score [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
Daytime Symptom Score [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
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 ]
Trough PEFR [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]
Physician's Global Evaluation Score on Pulmonary Function Testing Day 29 [ Time Frame: Prior to pulmonary function test on Day 29 ]
Physician's Global Evaluation Score on Pulmonary Function Testing Day 57 [ Time Frame: Prior to pulmonary function test on Day 57 ]
Physician's Global Evaluation Score on Pulmonary Function Testing Day 85 [ Time Frame: Prior to pulmonary function test on Day 85 ]
Chronic Obstructive Pulmonary Disease (COPD) Excerbation During the on-Treatment Period [ Time Frame: During the 12-week on-treatment period ]
COPD Excerbation During the on-Treatment Period [ Time Frame: During the 12-week on-treatment period ]

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

Arms	Assigned Interventions
COMBIVENT Respimat 20/100 mcg: Experimental	Drug: Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT
COMBIVENT CFC-MDI 36/206 mcg: Experimental	Drug: COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
Ipratropium Respimat 20 mcg: Experimental	Drug: Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI

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

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

Show 180 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1012.56
Study First Received:	November 15, 2006
Results First Received:	April 3, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00400153 History of Changes
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)

Study placed in the following topic categories:

Lung Diseases, Obstructive
Ipratropium
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Chronic Disease
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on July 02, 2009