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Clinical Comparability of Ventolin Formulated With Hydrofluoroalkane or Conventional Chlorofluorocarbon Propellants in Children With Asthma
Gail Shapiro, MD;
Edwin Bronsky, MD;
Andrea Murray, BS;
Frank Barnhart, DVM;
Anna VanderMeer, BS;
Colin Reisner, MD
Arch Pediatr Adolesc Med. 2000;154:1219-1225.
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.
From A.S.T.H.M.A., Inc, Seattle, Wash (Dr Shapiro); Intermountain Clinical Research, Salt Lake City, Utah (Dr Bronsky); and Glaxo Wellcome Inc, Research Triangle Park, NC (Mss Murray and VanderMeer and Drs Barnhart and Reisner). Drs Shapiro and Bronsky have received grant support from Glaxo Wellcome Inc and monetary compensation for speaking engagements from several pharmaceutical companies, including Glaxo Wellcome Inc.
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