W. Lumry et al., Switching from Ventolin CFC to Ventolin HFA is well tolerated and effective in patients with asthma, ANN ALLER A, 86(3), 2001, pp. 297-303
Background: Environmental imperatives to eliminate the use of chlorofluoroc
arbon (CFC) propellants in metered-dose inhalers have led to the developmen
t of metered-dose inhalers with the hydrofluoroalkane (HFA-134a) propellant
s.
Objectives: To evaluate the clinical effect of switching from Ventolin CFC
to Ventolin HFA and to compare the efficacy and safety of Ventolin CFC, Ven
tolin HFA, and placebo in patients with asthma.
Methods: Multicenter, double-blind, randomized safety and efficacy trial co
mparing regular use of Ventolin CFC versus Ventolin HFA versus placebo for
12 weeks in 313 patients with asthma aged 12 years and older who received V
entolin CFC during a 3-week run-in period.
Results: Patients who were switched from Ventolin CFC to Ventolin HFA maint
ained pulmonary function and other measures of asthma control at levels com
parable with run-in baseline. Serial pulmonary function testing demonstrate
d that both Ventolin treatments had significantly greater mean improvement
in FEV1 over baseline than the placebo group at treatment day 1 and weeks 6
and 12 (P < .001). Both Ventolin groups had comparable pulmonary function
at every visit. Predose FEV1 values were maintained or improved over time w
ith all treatments. Treatments were well-tolerated. The adverse event profi
le for both Ventolin treatments was comparable with placebo. No clinically
relevant effects on EGG, vital signs, or clinical laboratory tests were not
ed. Asthma exacerbation rates were 4% to 5% in the Ventolin groups and slig
htly higher (8%) in the placebo group.
Conclusions: Patients who were switched from Ventolin CFC to Ventolin HFA m
aintained comparable asthma control with a similar safety profile.