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

Nancy K. Ostrome， Herminia Taverase， Harald Iversone， David S. Pearlmane

Background

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.

respiratory medicine

November 2015Volume 109, Issue 11, Pages 1410–1415

DOI: http://dx.doi.org/10.1016/j.rmed.2015.09.004 |