Budesonide/Formoterol Pressurized Metered-Dose Inhaler versus Budesonide: A Randomized Controlled Trial in Black Patients with Asthma

Abstract

Objective. Concerns exist that responses to long-acting β₂-adrenergic agonists in black patients may differ from the general population. The efficacy and safety of budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) versus budesonide dry powder inhaler (BUD DPI) were evaluated in adolescent and adult black asthma patients. Methods. This 12-week, randomized, double-blind, multicenter, phase IV US study was conducted in 311 self-reported black patients aged ≥12 years with moderate to severe persistent asthma, previously receiving medium- to high-dose inhaled corticosteroid. After 2 weeks on BUD 90 μg × 2 inhalations twice daily (bid), symptomatic patients were randomized to BUD/FM 160/4.5 μg × 2 inhalations bid or BUD 180 μg × 2 inhalations bid. Results. Improvement in predose forced expiratory volume in 1 second from baseline to the treatment mean (primary variable) was greater with BUD/FM versus BUD (0.16 vs. 0.07 L; p = .008); this effect was also observed at weeks 2, 6, and end of treatment (p ≤ .032). Greater improvements (p < .001) in peak expiratory flow with BUD/FM versus BUD were seen at first measurement and maintained during 12 weeks (morning: 25.34 vs. 7.53 L/minute, respectively; evening: 21.61 vs. 7.67 L/minute, respectively); greater improvements in daily asthma symptom score and rescue medication use were also observed (p ≤ .039). Both treatments were well tolerated, with similar safety profiles. Conclusions. In this population of black asthma patients, BUD/FM pMDI resulted in greater improvements in pulmonary function and asthma control versus BUD DPI, with similar safety profiles.

• African American
• BUD DPI
• BUD/FM pMDI
• efficacy
• pharmacotherapy
• race
• safety

Acknowledgements

The authors acknowledge Marissa Buttaro, M.P.H., and Cynthia Gobbel, Ph.D., from Scientific Connexions (Newtown, PA), for writing assistance.

This work and writing assistance were supported by AstraZeneca LP, Wilmington, Delaware.

Dr. Spector has received consultant or speaker fees from AstraZeneca and Novartis and research grants from Amgen, AstraZeneca, Boehringer Ingelheim, Genentech/Novartis, GlaxoSmithKline, KarmelSonix, Medpoint, Merck, Novartis, Schering Plough, TKL Perrigo, sanofi-aventis, and Sunovion. Dr. Martin, Mr. Uryniak, and Dr. O’Brien are employees of and own stock in AstraZeneca LP.

Dr. Spector contributed substantially to the acquisition and interpretation of data, revised the manuscript critically for important intellectual content, and provided final approval of the submitted version of the manuscript for publication. Dr. Martin contributed substantially to the conception and design of the study and the analysis and interpretation of data, revised the manuscript critically for important intellectual content, and provided final approval of the submitted version of the manuscript for publication. Mr. Uryniak contributed substantially to the analysis and interpretation of data, revised the manuscript critically for important intellectual content, and provided final approval of the submitted version of the manuscript for publication. Dr. O’Brien contributed substantially to the conception and design of the study and the analysis and interpretation of data, revised the manuscript critically for important intellectual content, and provided final approval of the submitted version of the manuscript for publication.