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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00400153

Run by

Boehringer Ingelheim

People needed

1480

Starts

2006-11-01

Last updated by the study team

2014-06-13

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).

You may not qualify if…

• 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.

Where it is running

• 1012.56.01051 Boehringer Ingelheim Investigational Site — Jasper, Alabama, United States
• 1012.56.01071 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 1012.56.01039 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• 1012.56.01012 Boehringer Ingelheim Investigational Site — Lakewood, California, United States
• 1012.56.01029 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1012.56.01043 Boehringer Ingelheim Investigational Site — Palo Alto, California, United States
• 1012.56.01089 Boehringer Ingelheim Investigational Site — Rancho Mirage, California, United States
• 1012.56.01021 Boehringer Ingelheim Investigational Site — Riverside, California, United States
• 1012.56.01033 Boehringer Ingelheim Investigational Site — San Jose, California, United States
• 1012.56.01020 Boehringer Ingelheim Investigational Site — Sepulveda, California, United States
• 1012.56.01045 Boehringer Ingelheim Investigational Site — Torrence, California, United States
• 1012.56.01040 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 1012.56.01050 Boehringer Ingelheim Investigational Site — Fort Collins, Colorado, United States
• 1012.56.01018 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
• 1012.56.01062 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
• 1012.56.01036 Boehringer Ingelheim Investigational Site — Hartford, Connecticut, United States
• 1012.56.01025 Boehringer Ingelheim Investigational Site — Stamford, Connecticut, United States
• 1012.56.01088 Boehringer Ingelheim Investigational Site — Waterbury, Connecticut, United States
• 1012.56.01007 Boehringer Ingelheim Investigational Site — Bay Pines, Florida, United States
• 1012.56.01058 Boehringer Ingelheim Investigational Site — Brandon, Florida, United States
• 1012.56.01010 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1012.56.01065 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1012.56.01024 Boehringer Ingelheim Investigational Site — DeLand, Florida, United States
• 1012.56.01001 Boehringer Ingelheim Investigational Site — Melbourne, Florida, United States
• 1012.56.01006 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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