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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Atrovent Respimat (20 mcg); Drug: COMBIVENT MDI (36/206 mcg); Drug: Placebo via corresponding inhaler for blinding purposes; Drug: Combivent Respimat (20 mcg/100 mcg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00400153

1012.56

Details and patient eligibility

About

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.

Enrollment: 1,480 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,480 participants in 3 patient groups

COMBIVENT Respimat 20/100 mcg

Experimental group

Treatment:

Drug: Placebo via corresponding inhaler for blinding purposes

Drug: Combivent Respimat (20 mcg/100 mcg)

COMBIVENT CFC-MDI 36/206 mcg

Experimental group

Treatment:

Drug: Placebo via corresponding inhaler for blinding purposes

Drug: COMBIVENT MDI (36/206 mcg)

Ipratropium Respimat 20 mcg

Experimental group

Treatment:

Drug: Atrovent Respimat (20 mcg)

Drug: Placebo via corresponding inhaler for blinding purposes