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Open Access Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with asthma

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Background:

Breath-actuated inhalers (BAI) eliminate the need for the hand-breath coordination required with standard metered-dose inhalers (MDI).

Objective:

To evaluate the efficacy and safety of beclomethasone dipropionate (BDP) administered via BAI.

Methods:

This 6-week, phase III, double-blind study included patients aged ≥12 years with persistent asthma. During the single-blind run-in, patients discontinued asthma medications and received twice-daily placebo BAI or MDI. At randomization, BAI patients received BDP BAI 320 μg/day, BDP BAI 640 μg/day, or placebo BAI, and MDI patients received BDP MDI 320 μg/day or placebo MDI. Assessments included standardized baseline-adjusted trough morning forced expiratory volume in 1 second (FEV1) area under the effect curve from 0 to 6 weeks (AUEC[0‐6 wk]) (obtained by clinic-based spirometry; the primary end point), morning peak expiratory flow (PEF), trough daily morning FEV1 (obtained by handheld spirometry), withdrawals, and tolerability.

Results:

Of 425 patients randomized, most were white (81%) and female (61%). BDP BAI 320 and 640 μg/day significantly improved FEV1 AUEC(0‐6 wk) versus placebo (p < 0.001). The BDP BAI treatment groups exhibited significantly improved morning PEF and daily morning FEV1 versus placebo (p < 0.001). Similar treatment effects were demonstrated for BDP MDI (p < 0.001). Fewer patients withdrew due to worsening asthma while taking BDP BAI 320 μg/day (n = 1), BDP BAI 640 μg/day (n = 0), and BDP MDI 320 μg/day (n = 1) versus placebo (n = 10). BDP BAI was well tolerated.

Conclusion:

BDP BAI demonstrated significant improvements in pulmonary function versus placebo, with results similar to BDP MDI. The safety profile of BDP BAI was comparable to BDP MDI, with no new safety signals.

The study was registered on ClinicalTrials.gov (NCT02513160), www.clinicaltrials.gov.
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Keywords: Inhalation; anti-asthmatic agents/therapeutic use; asthma/drug therapy; beclomethasone/administration and dosage; beclomethasone/therapeutic use; breath actuated; controlled clinical trial; inhaled corticosteroids; lung diseases/drug therapy; treatment outcome

Document Type: Research Article

Affiliations: 1: From the Allergy & Asthma Medical Group & Research Center, San Diego, California, USA 2: Bethesda Allergy Asthma and Research Center, L.L.C., Bethesda, Maryland, USA 3: The Clinical Research Center, St. Louis, Missouri, USA 4: Global Statistics, Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA 5: Global Respiratory Research and Development, Teva Pharmaceutical Industries, Malvern, Pennsylvania, USA

Publication date: 01 March 2018

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.

    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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