Clinical comparability of ventolin formulated with hydrofluoroalkane or conventional chlorofluorocarbon propellants in children with asthma

Background: Aerosolized asthma medications with chlorofluorocarbon (CFC) pr opellants are being phased out because of environmental concerns about the ozone layer. Medications are being reformulated with non-ozone-depleting pr opellants. Objective: To evaluate the clinical comparability of albuterol sulfate form ulated in a new hydrofluoroalkane-134a (HFA) propellant (Ventolin HFA Inhal ation Aerosol),and conventional CFC-containing albuterol (Ventolin Inhalati on Aerosol) in children with asthma. Design: Randomized, double-blind, placebo-controlled 2-week clinical trial with a 1- to 2-week run-in period. During the run-in, patients took Ventoli n CFC as needed. Patients (n=135) aged 4 to 11 years with asthma then were assigned randomly to treatment with Ventolin HFA, Ventolin CFC, or placebo administered 4 times daily via metered-dose inhaler for 2 weeks. All patien ts were allowed rescue albuterol use in matching propellant as needed for r elief of breakthrough symptoms. The main outcome measure was the mean perce ntage of predicted peak expiratory flow (PEF) after the morning dose of stu dy drug on day 1 and after 2 weeks as assessed by results of 6-hour serial tests. Results: At day 1, the mean (+/- SE) percentage of predicted PEF increased postdose by 14% (+/- 1%) in the Ventolin HFA group and 13% (+/-1%) in the V entolin CFC group compared with 6% (+/- 2%) in the placebo group (P less th an or equal to .006). At week 2, mean postdose increases were 11% (+/- 1%) in the Ventolin HFA and CFC groups compared with 5% (+/- 1%) in the placebo group (P<.001). There were no significant differences between the Ventolin HFA and CFC groups in postdose increases in pulmonary function, time to on set of response, duration of response, or peak effects. Safety profiles wer e similar among the 3 groups. Conclusion: Ventolin HFA is clinically comparable to Ventolin formulated wi th the conventional CFC-containing propellant when administered to children with asthma.