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Open Access Albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane versus placebo in children with persistent asthma

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Background:

Many children struggle with albuterol hydrofluoroalkane (HFA) inhalers. Albuterol multidose dry powder inhaler (MDPI) may simplify rescue bronchodilator use in children.

Objective:

To demonstrate the comparability of albuterol MDPI and albuterol HFA in children with asthma.

Methods:

This phase II, multicenter, double-blind, double-dummy, single-dose, five-period, crossover study randomized patients (ages 4‐11 years) with persistent asthma and prestudy forced expiratory volume in 1 second (FEV1) of 60‐90% of predicted to 1 of 10 treatment sequences that contained albuterol MDPI (90 and 180 μg), albuterol HFA (90 and 180 μg), and placebo MDPI and placebo HFA. Efficacy was evaluated by measuring the area under the baseline-adjusted percent-predicted FEV1‐time curve over 6 hours (PPFEV1 AUC0‐6) after dosing. Safety was evaluated by adverse events.

Results:

The full analysis set included 61 patients. Albuterol MDPI and albuterol HFA significantly improved PPFEV1 AUC0‐6 versus placebo (p ≤ 0.0107). Mean improvement (± standard error [SE]) in PPFEV1 AUC0‐6 versus placebo with albuterol MDPI at 90 and 180 μg was similar (21.2 ± 4.87 [95% confidence interval {CI}, 11.60‐30.81], and 22.6 ± 4.87 [95% CI, 13.00‐32.20], %·hour, respectively). Mean improvement (± SE) with albuterol HFA 180 μg was significantly (p = 0.0226) greater versus albuterol HFA 90 μg (23.7 ± 4.85 [95% CI, 14.13‐33.23], and 12.5 ± 4.85 [95% CI, 2.93‐22.05], %·hour, respectively). All doses of albuterol were well tolerated.

Conclusion:

Albuterol MDPI 90 and 180 μg and albuterol HFA 180 μg provided similar and significant FEV1 improvements versus placebo; albuterol HFA 90 μg was significant versus placebo but seemed less effective based on absolute improvements in FEV1. ClinicalTrials.gov identifier: NCT01899144

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Keywords: Dry powder inhaler; albuterol; asthma; children; dose response; efficacy; hydrofluoroalkane; pediatric; safety; short-acting β2 adrenergic agonist

Document Type: Research Article

Publication date: September 1, 2016

This article was made available online on August 15, 2016 as a Fast Track article with title: "Albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane versus placebo in children with persistent asthma ".

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma and by having the potential to directly impact the quality of patient care. AAP welcomes the submission of original works including peer-reviewed original research and clinical trial results. Additionally, as the official journal of the Eastern Allergy Conference (EAC), AAP will publish content from EAC poster sessions as well as review articles derived from EAC lectures.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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