Studying Albuterol Efficacy in Children with Persistent Asthma

Both albuterol multidose dry powder inhaler (MDPI) and albuterol hydrofluoroalkane (HFA) outperformed placebo in a recent phase II trial.

Both albuterol multidose dry powder inhaler (MDPI) and albuterol hydrofluoroalkane (HFA) outperformed placebo in a recent phase II trial. The study, which was published in the September/October issue of Allergy and Asthma Proceedings, was conducted by Paul Qaqundah, MD, of the Department of Pediatrics in the Hoag Medical Group in Huntington Beach, CA, and colleagues.

“Until recently,” say the authors, “the only available inhaler device for delivery of albuterol was the metered-dose inhaler (MDI), which delivers the drug in aerosolized form.” However, many patients, especially children, struggle to properly use an MDI. An easier-to-use device, the MDPI has been approved, and the study “was designed to demonstrate the comparability of albuterol MDPI and albuterol HFA in children with persistent asthma.”

The study was a phase II, randomized, double-blind, placebo-controlled study of pediatric patients conducted at 14 locations in the United States. There was a final total of 56 participants, none of whom suffered serious adverse events. Patients receiving MDPI or HFA showed significant improvements in forced expiratory volume in 1 second (FEV1) compared to those receiving placebo.

The authors acknowledge some limitations, including the small number of participants, the single-dose design, and the lack of a questionnaire to establish patient preferences regarding inhalers. The researchers conclude by saying, “In this study in children ages 4 to 11 years, albuterol MDP was significantly more effective than placebo across all study end points and had similar safety and efficacy compared with albuterol HFA.”

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