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

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

Drug: Albuterol HFA MDI
Drug: Combivent® CFC MDI

Study type

Interventional

Funder types

Industry

Identifiers

NCT00096616
1012.50

Details and patient eligibility

About

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.

Enrollment

113 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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