A Single Dose, Randomized, Double-blind Crossover Comparison of Combivent CFC MDI and Albuterol HFA MDI in Patients With Moderate to Severe Persistent Asthma and Persistent Symptoms Despite Treatment With Inhaled Corticosteroids

Boehringer Ingelheim18 sites in 1 country113 target enrollmentNovember 2004

ConditionsAsthma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Enrollment: 113
Locations: 18
Primary Endpoint: FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate the superior bronchodilator efficacy of inhaled Combivent® CFC MDI vs. Albuterol HFA MDI in moderate to severe asthma patients.

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

March 2006

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

•Patient greater than or equal to 18 years of age,
•non-smokers,
•diagnosed with asthma, with an FEV1 less than or equal to 70 percent of predicted normal,
•stable use of Beta agonist
•daily use of inhaled steroids for one year

Exclusion Criteria

•Patients with other significant diseases other than asthma, requiring oxygen,
•intubated within 5 years,
•asthma exacerbation within 6 weeks of trial,
•use of unstable doses (greater than 10 mg/day of prednisone or equivalent) of steroids,
•participating in another interventional trial