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| 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 b e 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 |
| MedlinePlus related topics: | COPD (Chronic Obstructive Pulmonary Disease) |
| ChemIDplus related topics: | Ipratropium Ipratropium bromide |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment |
| Official Title: | Safety and Efficacy of Combivent Respimat in COPD |
| Estimated Enrollment: | 1440 |
| Estimated Study Completion Date: | July 2008 |
Eligibility
| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 |
Show 164 Study Locations |
| Boehringer Ingelheim Pharmaceuticals |
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
| Study ID Numbers: | 1012.56, EudraCT No.: 2006-002694-52 |
| First Received: | November 15, 2006 |
| Last Updated: | May 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00400153 |
| Health Authority: | United States: Food and Drug Administration |
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