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(Chest. 1996;109:702-707.)
© 1996 American College of Chest Physicians

Cumulative Dose-Response Study of Non-CFC Propellant HFA 134a Salbutamol Sulfate Metered-Dose Inhaler in Patients With Asthma

Eric C. Kleerup MD1; Donald P. Tashkin MD1; Ann C. Cline 2; and Bruce P. Ekholm MS2

1 From the Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of California, Los Angeles, School of Medicine
2 From the 3M Pharmaceuticals, St. Paul, Minn

Study objective: This study compares the safety and efficacy of HFA 134a salbutamol sulfate (Airomir in the 3M CFC-free system [3M Pharmaceuticals]) and CFC 11/12 salbutamol (Ventolin [Allen & Hanburys]) in a cumulative dose-response (1, 1, 2, 4, 8 inhalations at 30-min intervals) study in asthmatic patients.

Design: Randomized, single-blind, two-period crossover study.

Participants: Twenty-four stable mild to moderate asthmatics.

Measurements and results: At all cumulative inhalations, the changes in FEV1 (absolute, percent, and percent predicted) and FVC were equivalent. There was also no significant difference in heart rate, serum potassium level, BP, 12-lead ECG, Holter monitor recordings, or adverse events. Both HFA 134a salbutamol sulfate and CFC 11/12 salbutamol displayed a significant dose-response for FEV1, FEF25-75%, FVC, serum potassium, heart rate, and systolic BP.

Conclusions: HFA 134a salbutamol sulfate and CFC 11/12 salbutamol produced clinically and statistically similar airway responses and side effects. These results indicate that HFA 134a salbutamol sulfate would be a safe and effective substitute for CFC 11/12 salbutamol.

Key Words: aerosol propellants • albuterol • asthma • bronchodilators • chlorofluorocarbon • hydrofluoroalkanes • ozone • potassium • salbutamol sulfate • spirometry

Submitted on June 23, 1995
Accepted on October 13, 2007




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