PURPOSE: Concerns exist that black patients with asthma may have a poor response to long-acting β2-adrenergic agonists (Chest. 2006;129:15-26). The safety of BUD/FM pMDI compared with BUD was assessed in black patients with moderate to severe persistent asthma.
METHODS: This 12-week, randomized, double-blind, phase IV study (NCT00702325) included 311 black (self-reported) patients aged ≥12 years with moderate to severe persistent asthma previously receiving medium- to high-dose ICS. Patients symptomatic after 2 weeks on BUD dry powder inhaler (DPI) 90μg ×2 inhalations twice daily (bid) were randomized to BUD/FM pMDI 160/4.5μg ×2 inhalations bid or BUD DPI 180μg ×2 inhalations bid.
RESULTS: Mean treatment exposure (days) was slightly longer for BUD/FM (72.8) versus BUD (67.4). AEs occurred in 63 (41.2%) and 47 (30.3%) patients in the BUD/FM and BUD groups, respectively. Most AEs were mild to moderate in intensity. The most common AEs (≥3% total) were headache (6.5% and 5.2%, respectively), nasopharyngitis (5.2% and 2.6%), and upper respiratory infection (2.6% and 3.9%). Three discontinuations due to AEs occurred: BUD/FM (2: dyspnea, foot fracture), BUD (1: asthma). Three serious AEs were reported during randomized treatment: BUD/FM (1: ruptured ovarian cyst), BUD (2: pyrexia, asthma exacerbation); none was considered treatment-related. The incidence of AEs judged treatment-related by the investigator was low (BUD/FM, 1.3%; BUD, 0.6%). Small, but statistically significant (P≤.013), differences in changes from baseline to end of treatment in sitting systolic and diastolic blood pressure were seen for BUD/FM (1.7 and 0.2 mmHg, respectively) versus BUD (-1.2 and -1.4 mmHg), but these changes remained within normal ranges. No meaningful differences were observed between treatment groups in pulse rate.
CONCLUSION: In this population of black patients with moderate to severe persistent asthma, the safety profile of BUD/FM pMDI was similar to that of BUD DPI and consistent with that observed in previous studies of BUD/FM.
CLINICAL IMPLICATIONS: Findings were consistent with those seen in the general population, supporting use of BUD/FM pMDI in black patients with asthma not controlled on ICS alone.
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