Randomized dose-ranging study of a budesonide metereddose inhaler by using co-suspension delivery technology in asthma.

Miller, S. David; Nyberg, Jack; Siddiqui, Shahid; Dorinsky, Paul; St Rose, Earl; Reisner, Colin

Background: This is the first study of the inhaled corticosteroid, budesonide, delivered by metered-dose inhaler (BD MDI) using innovative co-suspension delivery technology in adults with asthma. Objective: To characterize the effects of BD delivered by MDI on lung function a safety. Methods: Randomized, double-blind, 4-week cross-over, placebo-controlled, phase lib study of adults (18-65 years of age) with mild-to-moderate persistent asthma. The subjects received twice-daily BD mdi 3,hg, 160, and placebo MDI, and either BD MDI 80 jxgor40 jxg. The primary endpoint was change from b ine in morning trough forced expiratory volume in 1 second (FEVt) at the end of the treatment period (EOT). Secondary endpoints included change from baseline in morning and evening predose peak expiratory flow rate (PEFR), rescue medication use, and Asthma Control Questionnaire 5-question version (ACQ-5) score. Safety was also assessed. Results: A total of 147 subjects were randomized. All doses of BD MDI improved morning trough FEVt at EOT, and morning and evening predose PEFR in the last treatment week versus placebo (all p < 0.01), with improvements in trough FEVt exceeding 100 mLfor BD MDI 320 jxg, and 160 jxg only. Compared with placebo, all BD MDI doses reduced rescue medication use in the last week of treatment (p < 0.01) and improved ACQ-5 scores at EOT (all p < 0.01). All treatments were well tolerated. Conclusion: Analysis of the data demons ted grea. efficacy improvements for the higher doses of BD MDI (320 jxg and 160 jxg), with similar adverse event profiles compared w 1 the lower doses. Hence, BD MDI 320 jxg and 160 jxg warrant further evaluation in subjects with persistent asthma.

ADRENOCORTICAL hormones; DRUG delivery systems; PLACEBOS; ASTHMA treatment; BUDESONIDE; DRUG dosage; THERAPEUTICS

Allergy & Asthma Proceedings, 2018, Vol 39, Issue 5, p350

1088-5412

Academic Journal

10.2500/aap.2018.39.4155