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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00096616

Enrollment

113

Registered

2004-11-15

Start date

2004-11-30

Completion date

Unknown

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGCombivent® CFC MDI

DRUGAlbuterol HFA MDI

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1	—

Secondary

Measure	Time frame
FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026