PURPOSE: Concerns exist that black patients with asthma may have an inherently poor response to long-acting β2-adrenergic agonists (Chest. 2006;129:15-26). The effect of budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) versus BUD on pulmonary function was compared in black patients with inhaled corticosteroid (ICS)-dependent asthma.
METHODS: This 12-week, randomized, double-blind, double-dummy multicenter phase IV US study (NCT00702325) included 311 black (self-reported) patients aged ≥12 years with moderate to severe persistent asthma treated previously with medium- to high-dose ICS. Patients who were symptomatic after a 2-week run-in on BUD dry powder inhaler (DPI) 90 μg ×2 inhalations twice daily (bid) were randomized to BUD/FM pMDI 160/4.5 μg ×2 inhalations bid or BUD DPI 180 μg ×2 inhalations bid.
RESULTS: Improvement in predose forced expiratory volume in 1 second (FEV1; primary variable) from baseline to the mean during the treatment period was greater with BUD/FM versus BUD (0.16 vs 0.07 L, respectively; P=.008). Improvements in predose FEV1 also were greater for BUD/FM versus BUD at weeks 2, 6, and 12 and end of treatment (P≤.032). Improvements in morning and evening peak expiratory flow from baseline to treatment mean significantly favored BUD/FM (25.34 and 21.61 L/min, respectively) versus BUD (7.53 and 7.67 L/min, respectively) (P<.001); this effect was seen from the time of the first measurement after the start of treatment and maintained over 12 weeks. Significantly greater improvements in forced vital capacity from baseline to treatment mean also were seen with BUD/FM versus BUD (0.14 vs 0.07 L, respectively; P=.035).
CONCLUSION: In this population of black patients with moderate to severe persistent asthma, BUD/FM pMDI resulted in significantly greater improvements in pulmonary function versus BUD DPI.
CLINICAL IMPLICATIONS: Pulmonary function response in this black population was consistent with results obtained in a similarly designed study containing BUD/FM and BUD arms that was conducted in a predominately (78%) white population with moderate to severe asthma (Drugs. 2006;66:2235-2254).
DISCLOSURE: Sheldon Spector, Grant monies (from industry related sources) This study was funded by AstraZeneca LP. Sheldon L. Spector has received research grants from AstraZeneca, Genentech, Novartis, Schering-Plough, Sepracor, GSK, Boehringer Ingelheim, Amgen.; Shareholder Sheldon L. Spector is a shareholder of Novartis and GSK stocks. Ubaldo J. Martin, Tom Uryniak, and Christopher D. O’ Brien are shareholders of AstraZeneca stocks.; Employee Ubaldo J. Martin, Tom Uryniak, and Christopher D. O’ Brien are employees of AstraZeneca.; Consultant fee, speaker bureau, advisory committee, etc. Sheldon L. Spector is on the Advisory Board of Alcon, AstraZeneca, Schering-Plough and is a speaker for Alcon, AstraZeneca, Genentech, Novartis, Schering-Plough, Merck.; Other Sheldon L. Spector has received honoraria from Alcon, Genentech, Novartis, Schering-Plough, Merck.; No Product/Research Disclosure Information