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Clinical efficacy and safety of fluticasone propionate 250 microg twice daily administered via a HFA 134a pressurized metered dose inhaler to patients with mild to moderate asthma. French study group.
- Source :
-
Respiratory medicine [Respir Med] 2000 Jun; Vol. 94 Suppl B, pp. S29-34. - Publication Year :
- 2000
-
Abstract
- This study compared the efficacy and safety of the fluticasone propionate 125 microg pressurized metered dose inhaler (pMDI) propelled by either hydrofluoroalkane (HFA) 134a or chlorofluorocarbon (CFC) propellants, in adult patients with asthma. HFA 134a is a non-ozone depleting propellant used as a replacement for the CFC propellants 11 and 12 which are being phased out in accordance with the Montreal Protocol. Three hundred and eighty patients with mild to moderate asthma and 'room for improvement' in their treatment were randomized to receive fluticasone propionate 250 microg twice daily via pMDIs propelled by either CFC propellants 11 and 12 (n = 195) or HFA 134a (n = 185). Fluticasone propionate significantly improved lung function over the 4-week treatment period in both treatment groups. The improvement in mean morning peak expiratory flow (PEF) after 7 days of treatment was approximately 12 l min(-1) in both groups, rising to approximately 22 l min(-1) at the end of the 4-week treatment period. The adjusted mean difference between the two formulations over weeks 1-4 was -1 l min(-1) (90% confidence interval: -7, 5 l min(-1)), confirming their equivalence. Clinical comparability was also demonstrated with respect to secondary efficacy variables, including daily symptom scores, evening PEF and clinic visit expiratory measurements. There were no clinically relevant differences in adverse events or serum cortisol levels between the two groups. The fluticasone propionate 125 microg HFA 134a pMDI is an effective and well tolerated product and is a suitable replacement for the fluticasone propionate 125 microg CFC pMDI at a microgram equivalent dose.
- Subjects :
- Administration, Inhalation
Adolescent
Adult
Aerosol Propellants adverse effects
Aged
Aged, 80 and over
Chlorofluorocarbons adverse effects
Chlorofluorocarbons pharmacokinetics
Double-Blind Method
Female
Fluticasone
Forced Expiratory Volume physiology
Humans
Hydrocarbons, Fluorinated adverse effects
Hydrocortisone blood
Male
Middle Aged
Peak Expiratory Flow Rate physiology
Therapeutic Equivalency
Treatment Outcome
Aerosol Propellants pharmacokinetics
Androstadienes administration & dosage
Anti-Asthmatic Agents administration & dosage
Asthma drug therapy
Hydrocarbons, Fluorinated pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 0954-6111
- Volume :
- 94 Suppl B
- Database :
- MEDLINE
- Journal :
- Respiratory medicine
- Publication Type :
- Academic Journal
- Accession number :
- 10919683