Cumulative dose-response study of non-CFC propellant HFA 134a salbutamol sulfate metered-dose inhaler in patients with asthma

Chest. 1996 Mar;109(3):702-7. doi: 10.1378/chest.109.3.702.


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 cross-over 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adrenergic beta-Agonists / administration & dosage
  • Adrenergic beta-Agonists / therapeutic use*
  • Adult
  • Albuterol / administration & dosage
  • Albuterol / therapeutic use*
  • Asthma / drug therapy*
  • Asthma / physiopathology
  • Chlorofluorocarbons
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Female
  • Forced Expiratory Volume
  • Humans
  • Hydrocarbons, Fluorinated
  • Male
  • Middle Aged
  • Single-Blind Method
  • Spirometry
  • Treatment Outcome


  • Adrenergic beta-Agonists
  • Chlorofluorocarbons
  • Hydrocarbons, Fluorinated
  • Albuterol
  • apaflurane