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

BACKGROUND

Aerosolized asthma medications with chlorofluorocarbon (CFC) propellants are being phased out because of environmental concerns about the ozone layer. Medications are being reformulated with non-ozone-depleting propellants.

OBJECTIVE

To evaluate the clinical comparability of albuterol sulfate formulated in a new hydrofluoroalkane-134a (HFA) propellant (Ventolin HFA Inhalation Aerosol), and conventional CFC-containing albuterol (Ventolin Inhalation 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 Ventolin 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 patients were allowed rescue albuterol use in matching propellant as needed for relief of breakthrough symptoms. The main outcome measure was the mean percentage of predicted peak expiratory flow (PEF) after the morning dose of study 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 Ventolin CFC group compared with 6% (+/- 2%) in the placebo group (P</=.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 onset of response, duration of response, or peak effects. Safety profiles were similar among the 3 groups.

CONCLUSION

Ventolin HFA is clinically comparable to Ventolin formulated with the conventional CFC-containing propellant when administered to children with asthma. Arch Pediatr Adolesc Med. 2000;154:1219-1225.