Status:

COMPLETED

Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Asthma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

113 Patients enrolled

Trial Details

Trial ID

NCT00096616

Start Date

November 1 2004

Last Update

November 1 2013

Active Locations (27)

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Page 1 of 7 (27 locations)

1

620 South 20th Street, NHB 104

Birmingham, Alabama, United States

2

Cooper Green Hospital

Birmingham, Alabama, United States

3

Southern California Clinical Trials

Lakewood, California, United States

4

Boehringer Ingelheim Investigational Site

Palmdale, California, United States