Official Title: “Safety and Efficacy of Combivent Respimat in COPD”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Intervention(s) in this Clinical Trial

• 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

Primary Measures

• There are three co-primary endpoints: (1) FEV1 AUC (0-6) Combivent Respimat? compared to COMBIVENT? MDI (2) FEV1 AUC (0-4) Combivent Respimat? compared to Atrovent Respimat? (3) FEV1 AUC (4-6) Combivent Respimat? compared to Atrovent Respimat

Secondary Measures

• (1) AM Peak Flow, (2) Beta agonist and steroid use, (3) COPD Daily Symptom Scores, (4) Physician Global Assessment (PGA) and (5) COPD Exacerbations.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00400153

Study ID Number: 1012.56

ClinicalTrials.gov Identifier: NCT00400153

Health Authority: United States: Food and Drug Administration