Salmeterol inhaler using a non-chlorinated propellant, HFA134a: systemic pharmacodynamic activity in healthy volunteers

BACKGROUND--Metered dose inhalers for the treatment of asthma use chlorofluorocarbons as propellants. These face an international ban due to their effect on the ozone layer. Salmeterol has been reformulated using the non-chlorinated propellant Glaxo inhalation grade HFA134a. METHODS--The safety, tol...

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Bibliographic Details
Published in:Thorax 1995-06, Vol.50 (6), p.679-681
Main Authors: Kirby, S M, Smith, J, Ventresca, G P
Format: Article
Language:English
Subjects:
Administration, Inhalation
Adrenergic beta-Agonists - adverse effects
Adrenergic beta-Agonists - pharmacokinetics
Adult
Aerosol Propellants - pharmacokinetics
Albuterol - adverse effects
Albuterol - analogs & derivatives
Albuterol - pharmacokinetics
Biological and medical sciences
Bronchodilator Agents - adverse effects
Bronchodilator Agents - pharmacokinetics
Cross-Over Studies
Dose-Response Relationship, Drug
Double-Blind Method
Humans
Hydrocarbons, Fluorinated - pharmacokinetics
Male
Medical sciences
Pharmacology. Drug treatments
Potassium - blood
Pulse - drug effects
Respiratory system
Salmeterol Xinafoate
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Summary:BACKGROUND--Metered dose inhalers for the treatment of asthma use chlorofluorocarbons as propellants. These face an international ban due to their effect on the ozone layer. Salmeterol has been reformulated using the non-chlorinated propellant Glaxo inhalation grade HFA134a. METHODS--The safety, tolerability and systemic pharmacodynamic activity of the salmeterol/HFA134a inhaler, the current salmeterol inhaler, and placebo (HFA134a) were compared in 12 healthy volunteers in a double blind, randomised crossover study using a cumulative dosing design. RESULTS--Safety and tolerability were similar and the response was related to the dose over the range used (50-400 micrograms) with both salmeterol inhalers. The salmeterol/HFA134a inhaler showed no differences from the current inhaler for pulse rate, blood pressure, tremor, QTc interval, and plasma glucose levels. The salmeterol/HFA134a inhaler had significantly less effect on plasma potassium levels. CONCLUSIONS--In healthy volunteers the salmeterol/HFA134a inhaler is at least as safe and well tolerated as the current salmeterol inhaler, and has similar systemic pharmacodynamic activity.
ISSN:0040-6376
1468-3296
DOI:10.1136/thx.50.6.679