Novel albuterol multidose dry powder inhaler in patients with exercise-induced bronchoconstriction: A single-dose, double-blind, randomized, 2-way crossover study

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• 作者：Nancy K. Ostrom^a ; ^{nkostrom@aol.com" class="auth_mail" title="E-mail the corresponding author} ; Herminia Taveras^b ; ^{herminia.taveras@tevapharm.com" class="auth_mail" title="E-mail the corresponding author} ; Harald Iverson^b ; ^{harald.iverson@tevapharm.com" class="auth_mail" title="E-mail the corresponding author} ; David S. Pearlman^c ; ^{ds.pearlman@coloradoallergy.com" class="auth_mail" title="E-mail the corresponding author}
• 关键词：Adrenergic beta-2 receptor agonists ; Albuterol ; Bronchoconstriction ; Dry powder inhalers ; Exercise-induced bronchospasm
• 刊名：Respiratory Medicine
• 出版年：2015
• 出版时间：November 2015
• 年：2015
• 卷：109
• 期：11
• 页码：1410-1415
• 全文大小：765 K

文摘

A novel, inhalation-driven, multidose dry powder inhaler (MDPI) was developed that eliminates the need to coordinate device actuation with inhalation as is required with conventional metered-dose inhalers.

Objective

To evaluate albuterol MDPI efficacy and safety in patients with exercise-induced bronchoconstriction (EIB).

Methods

This single-dose, double-blind, 2-way crossover study randomized adolescents and adults with EIB (≥20% fall from pre-exercise challenge FEV₁) to treatment sequences of albuterol MDPI (180 μg [2 inhalations of 90 μg each])/placebo MDPI (n = 19) or the reverse sequence (n = 19). FEV₁ was measured 30 and 5 min predose, 30 min postdose (ie, 5 min before treadmill exercise challenge; baseline) and 5, 10, 15, 30, and 60 min after exercise challenge. The primary efficacy endpoint was maximum percentage fall from baseline in FEV₁ up to 60 min post-exercise challenge.

Results

Mean maximum percentage fall in FEV₁ within 60 min post-exercise challenge was 6.2 ± 1.4% for albuterol MDPI versus 22.4 ± 1.4% for placebo MDPI (between-treatment difference: −16.2%; 95% CI: −20.2% to −12.1%; P < 0.0001). A significantly higher percentage of albuterol MDPI–treated patients were protected against EIB (<10% maximum FEV₁ fall post-exercise challenge) versus placebo MDPI (84.2% vs 15.8%; P < 0.0001). Protection with albuterol MDPI was evident within 5 min and maintained through 30 min; recovery was complete for both groups at 60 min. Treatment with a single dose of albuterol MDPI was generally well tolerated.

Conclusions

Albuterol MDPI provides clinically significant protection from EIB in adolescents and adults with EIB; no new safety issues were observed with short-term albuterol MDPI use. ClinicalTrials.gov identifier NCT01791972.