Cumulative dose-response study of non-CFC propellant HFA 134a salbutamol sulfate metered-dose inhaler in patients with asthma.
Chest
; 109(3): 702-7, 1996 Mar.
Article
em En
| MEDLINE
| ID: mdl-8617079
ABSTRACT
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 ANDRESULTS:
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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Asma
/
Agonistas Adrenérgicos beta
/
Albuterol
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Chest
Ano de publicação:
1996
Tipo de documento:
Article
País de afiliação:
Estados Unidos