This article is part of Pulmonology Advisor‘s coverage of the ACAAI 2018 meeting, taking place in Seattle, Washington. Our staff will report on medical research related to allergy, asthma, and more conducted by experts in the field. Check back regularly for more news from ACAAI 2018.
SEATTLE — Beclomethasone dipropionate (BDP) delivered by breath-actuated inhaler (BAI) at 320 mcg/d and 640 mcg/d was associated with improvements in lung function in adolescents and adults with persistent asthma, according to research presented at the 2018 Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology held in Seattle, November 15-19, 2018, and published in Allergy and Asthma Proceedings.1,2
“The treatment effect of BDP delivered via a novel BAI was evaluated overall, and also according to pre-study therapy to see if the latter influenced efficacy,” the researchers wrote in the introduction of their abstract. “The safety profile of this new BDP BAI device was comparable to the established safety profile of BDP metered-dose inhaler (MDI), with no new safety signals.”
During the 6-week phase 3 study (ClinicalTrials.gov Identifier: NCT02513160), 425 patients with persistent asthma (age ≥12 years) who had a history of noncorticosteroids, inhaled corticosteroids, or inhaled corticosteroids/long-acting beta-2 agonist use were enrolled. Participants were randomly assigned to either a placebo BAI, a placebo MDI, 320 mcg/d BDP by BAI, 640 mcg/d BDP by BAI, or 320 mcg/d BDP by MDI. Treatment was administered after a short washout/inhaler training period. Throughout the course of the study, investigators allowed the use of rescue medication (eg, albuterol/salbutamol) MDI or equivalent, when indicated.
The researchers observed significant improvements from baseline in lung function in patients who received either the 320 mcg/d or the 640 mcg/d doses of BDP by BAI vs placebo (P <.001).2 From baseline to 6-week follow-up, significantly greater improvements were observed in the baseline-adjusted trough morning forced expiratory volume in 1 second (FEV1) area under the effect curve in BDP-treated vs placebo-treated patients (P <.001).2
Patients who received inhaled corticosteroids at baseline experienced comparable treatment effects of both doses of BDP BAI and MDI for all secondary endpoints, which included change form baseline in trough morning peak expiratory flow, change from baseline in total daily rescue medication use, change from baseline in trough morning FEV1, change from baseline in total daily asthma symptom score, and time to withdrawal due to meeting stopping criteria for worsening asthma.
“The BAI may offer advantages over the MDI in patients with less rigorous training,” the authors added. The study was not powered to compare the different doses of BDP or the BAI and MDI devices, which represents a limitation of the analysis.
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- Carr W, Ostrom NK, Hickey L, Small CJ. Beclomethasone dipropionate delivered via breath-actuated inhaler in persistent asthma: efficacy evaluation according to prior treatment. Presented at: the Annual Scientific Meeting of the American College of Allergy, Asthma, and Immunology; November 15-19, 2018; Seattle, WA. Poster P212.
- Ostrom NK, Raphael G, Tillinghast J, Hickey L, Small CJ. Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with asthma. Allergy Asthma Proc. 2018;39(2):117-126.