CLINICAL EQUIVALENCE OF A NOVEL NON-CHLOROFLUOROCARBON-CONTAINING SALBUTAMOL SULFATE METERED-DOSE INHALER AND A CONVENTIONAL CHLOROFLUOROCARBON INHALER IN PATIENTS WITH ASTHMA
R. Dockhorn et al., CLINICAL EQUIVALENCE OF A NOVEL NON-CHLOROFLUOROCARBON-CONTAINING SALBUTAMOL SULFATE METERED-DOSE INHALER AND A CONVENTIONAL CHLOROFLUOROCARBON INHALER IN PATIENTS WITH ASTHMA, Journal of allergy and clinical immunology, 96(1), 1995, pp. 50-56
Background: New formulations of non-chlorofluorocarbon-containing prop
ellants for pressurized metered-dose inhaler delivery systems must be
developed in response to the forthcoming ban on chlorofluorocarbon (CF
C) production. Objective: This study compared the bronchodilator effec
ts of 100, 200, and 300 mu g (base equivalent) of salbutamol in a nove
l CFC-free propellant system (Airomir in the 3M CFC-Free System; 3M Ph
armaceuticals, St. Paul Minn.; 108 mu g of salbutamol sulfate or 90 mu
g of salbutamol base equivalent per inhalation) with that of 100 and
200 mu g of salbutamol base in a conventional CFC propellant system (V
entolin, CFC-11/12; Allen and Hanburys, Division of Glaxo Inc., Resear
ch Triangle Park, N.C.; 90 mu g of salbutamol base per inhalation) and
placebo. Methods: Twenty-six patients with chronic, stable asthma, wh
o had a forced expiratory volume in 1 second (FEV(1)) between 50.0% an
d 75.0% of predicted normal value entered this randomized double-blind
, double-dummy, 6-period, crossover study. FEV(1) was measured before
and at multiple time points (ranging from 10 to 480 minutes) after adm
inistration of one, two, and three inhalations of salbutamol/CFC-free
(100, 200, and 300 mu g); one and two inhalations of salbutamol/CFC (1
00 and 200 mu g); and placebo. Safety parameters included adverse even
ts, heart rate, blood pressure, physical examinations, electrocardiogr
ams, and clinical laboratory tests. Parametric analysis of variance mo
dels appropriate for a 6-period crossover design were used, along with
multiple comparisons according to Tukey's method. Results: All active
treatments produced significantly (p < 0.0001) greater bronchodilatio
n than placebo. The bronchodilator effect, as measured by FEV(1) (peak
percent change, peak as a percent of predicted value duration, and ar
ea under the curve) after two inhalations of salbutamol/CFC-free was c
linically comparable to two inhalations of salbutamol/CFC, with no cli
nically meaningful differences in safety parameters between the two de
livery systems or between different dose levels. Conclusion: These res
ults suggest that salbutamol/CFC-free may offer a suitable alternative
for salbutamol/CFC when the need arises to change front CFC-containin
g salbutamol products.