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

Boehringer Ingelheim113 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

113

Conditions

Asthma

Interventions

Combivent® CFC MDIDRUG

Albuterol HFA MDIDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Outcomes

Primary Outcomes

FEV1 area under the curve (AUC) 0 to 6 hours Peak FEV1

Secondary Outcomes

FEV1 at each timepoint Peak FVC FVC at each timepoint FVC AUC 0-6 Adverse events Vital signs

Data from ClinicalTrials.gov

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620 South 20th Street, NHB 104

Birmingham, Alabama, United States

Cooper Green Hospital

Birmingham, Alabama, United States

Southern California Clinical Trials

Lakewood, California, United States