PURPOSE: To assess whether disease severity affects the response to asthma treatment, response to BUD/FM pMDI was assessed by asthma severity in 2 different moderate to severe persistent asthma populations.
METHODS: Patients received twice-daily BUD/FM pMDI 320/9 μg versus BUD (pMDI 320 μg or dry powder inhaler 360 μg) in 2 double-blind, 12-week, randomized studies of predominantly (85%) nonblack (study I [n=233 (2 of 5 treatment arms); moderate: n=172, severe: n=61]: NCT00652002; Drugs.2006;66:2235) or self-reported (100%) black (study II [N=301 (total population); moderate: n=204, severe: n=97]: NCT00702325) populations. By convention, severity was assigned based on ICS dose at study entry (moderate, 160-280; severe, >280 μg/day beclomethasone hydrofluoroalkane or equivalent).
RESULTS: Predose FEV1 improvements from baseline to treatment average were greater with BUD/FM versus BUD, respectively, in severe (I: 0.20 vs -0.10; II: 0.17 vs 0.03 L) and moderate (I: 0.18 vs 0.10; II: 0.16 vs 0.09 L) asthma patients; in the BUD/FM groups (both studies), improvements in predose FEV1 were similar in the severe and moderate categories. PEF improvements were greater with BUD/FM versus BUD in severe (I: AM 30.1 vs 8.7, PM 30.6 vs 2.7; II: AM 28.9 vs 6.5, PM 26.7 vs 2.7 L/min) and moderate (I: AM 36.8 vs 7.7, PM 34.5 vs 6.8; II: AM 23.9 vs 8.1, PM 19.5 vs 10.3 L/min) asthma patients. Increases in percentage of asthma control days were greater with BUD/FM versus BUD in severe (I: 12.1% vs 1.3%; II: 21.3% vs 12.0%) and moderate (I: 19.9% vs 8.0%; II: 22.2% vs 16.8%) asthma patients.
CONCLUSIONS: Greater improvements in pulmonary function and asthma control days were observed with BUD/FM versus BUD in patients with moderate and severe persistent asthma based on ICS dose at entry, with generally similar results in moderate and severe patients and in predominantly nonblack and black asthma populations.
CLINICAL IMPLICATIONS: Findings from 2 separate ethnic populations support BUD/FM pMDI 320/9-μg use in severe asthma patients uncontrolled on ICS.
DISCLOSURE: Randall Brown: Consultant fee, speaker bureau, advisory committee, etc.: Merck & Company, Inc; Teva Pharmaceuticals, Grant monies (from industry related sources): AstraZeneca LP
Lanny Rosenwasser: University grant monies: Children's Mercy Hospital Physician Scientist award, Grant monies (from industry related sources): Novartis, Genentech, Employee: Children's Mercy Hospital, Fiduciary position (of any organization, association, society, etc, other than ACCP: Secretary General WAO, Consultant fee, speaker bureau, advisory committee, etc.: NIH, AstraZeneca LP, Alcon, Sanofi-Aventis, Regeneron
Tom Uryniak: Employee: AstraZeneca LP, Shareholder: AstraZeneca LP
Ubaldo Martin: Employee: AstraZeneca LP, Shareholder: AstraZeneca LP
James Zangrilli: Employee: AstraZeneca LP, Shareholder: AstraZeneca LP
No Product/Research Disclosure Information