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Obstructive Lung Diseases |

Asthma Control and Study Withdrawal in Patients With Versus Without Fixed Airflow Obstruction (2 Criteria): Post Hoc Analysis of a Budesonide/Formoterol Pressurized Metered-Dose Inhaler Study in Patients With Moderate to Severe Asthma

Donald Tashkin*, MD; Bradley Chipps, MD; Tom Uryniak, MS; Frank Trudo, MD; James Zangrilli, MD
Author and Funding Information

University of California Los Angeles, Los Angeles, CA


Chest. 2012;142(4_MeetingAbstracts):686A. doi:10.1378/chest.1371955
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Abstract

SESSION TYPE: Asthma Treatment

PRESENTED ON: Monday, October 22, 2012 at 11:15 AM - 12:30 PM

PURPOSE: To explore the effect of fixed airflow obstruction (FAO) on asthma treatment response.

METHODS: Data were from a 12-week, randomized, double-blind study (NCT00652002) in patients ≥12 years with moderate-severe asthma (Drugs.2006;66:2235-54). Withdrawals (any reason or asthma event [predefined criteria for worsening pulmonary function or asthma control]) and changes from baseline in asthma control days (% of days with no symptoms or rescue medication use) were stratified by FAO category (screening post-albuterol FEV1/FVC ratio < lower limit of normal [LLN][with] vs ≥LLN[without] or <0.70[with] vs ≥0.70[without]). Treatments: twice-daily BUD/FM pMDI 320/9μg (LLN:with[n=50],without[n=66]; 0.70:with[n=47],without[n=77]); BUD pMDI 320μg (LLN:with[n=36],without[n=65]; 0.70:with[n=32],without[n=77]); FM DPI 9μg (LLN:with[n=45],without[n=67]; 0.70:with[n=38],without[n=85]); placebo (LLN:with[n=47],without[n=74]; 0.70:with[n=39],without[n=86]).

RESULTS: Approximately 43% of patients met either FAO criterion. Patients with versus without FAO (LLN definition) had similar age (41.1y vs 41.5y), were more likely male (41.6% vs 34.2%), and had longer asthma duration (26.0y vs 20.3y); results were similar using the 0.70 definition, except for age (46.5y vs 38.3y). Study withdrawal with versus without FAO (LLN): Any Reason (placebo, 70.2% vs 54.1%; FM, 60.0% vs 44.8%; BUD, 36.1% vs 26.2%; BUD/FM, 24.0% vs 19.7%); Due to Predefined Asthma Event (placebo, 57.4% vs 44.6%; FM, 48.9% vs 29.9%; BUD, 19.4% vs 21.5%; BUD/FM, 8.0% vs 13.6%). Improvements in asthma control days with versus without FAO (LLN): placebo, −1.2% vs 2.5%; FM, 4.8% vs 5.2%; BUD, 2.2% vs 8.5%; BUD/FM, 16.9% vs 18.5%. Overall results were similar using the 0.70 definition.

CONCLUSIONS: FAO predicts an at-risk population in terms of greater study withdrawals and fewer asthma control days relative to without FAO. Fewer withdrawals and more asthma control days were seen with BUD/FM versus other treatments, irrespective of FAO category.

CLINICAL IMPLICATIONS: The presence of FAO in moderate to severe asthma patients (post bronchodilator FEV1/FVC ratio <LLN or <0.70) identified a population at increased risk for loss of asthma control relative to those not meeting FAO criteria. Patients with FAO demonstrated better controller response to BUD/FM than to BUD alone.

DISCLOSURE: Donald Tashkin: University grant monies: Donald Tashkin's institution (UCLA) manages research funds received from AstraZeneca, Grant monies (from industry related sources): Donald Tashkin received grant funding from AstraZeneca, Consultant fee, speaker bureau, advisory committee, etc.: Donald Tashkin is a speaker and has served on an advisory committee for AstraZeneca. Bradley Chipps is an advisor or consultant for Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, Merck-Schering, ISTA, Quintiles, and Dey, and is on a speaker bureau forAlcon, Genentech, AstraZeneca, GlaxoSmithKline, Meda, Novartis, Sunovion, Merck-Schering, ISTA, and Dey , Employee: Tom Uryniak, Frank Trudo, and James Zangrilli are employees of AstraZeneca, Shareholder: Tom Uryniak and James Zangrilli are stockholders in AstraZeneca, Other: Bradley Chipps received funding for clinical research from Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, and Merck-Schering, and he received grants for educational activities from Alcon, Genentech, AstraZeneca, GlaxoSmithKline, and Novartis

Bradley Chipps: University grant monies: Donald Tashkin's institution (UCLA) manages research funds received from AstraZeneca, Grant monies (from industry related sources): Donald Tashkin received grant funding from AstraZeneca, Consultant fee, speaker bureau, advisory committee, etc.: Donald Tashkin is a speaker and has served on an advisory committee for AstraZeneca. Bradley Chipps is an advisor or consultant for Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, Merck-Schering, ISTA, Quintiles, and Dey, and is on a speaker bureau forAlcon, Genentech, AstraZeneca, GlaxoSmithKline, Meda, Novartis, Sunovion, Merck-Schering, ISTA, and Dey , Employee: Tom Uryniak, Frank Trudo, and James Zangrilli are employees of AstraZeneca, Shareholder: Tom Uryniak and James Zangrilli are stockholders in AstraZeneca, Other: Bradley Chipps received funding for clinical research from Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, and Merck-Schering, and he received grants for educational activities from Alcon, Genentech, AstraZeneca, GlaxoSmithKline, and Novartis

Tom Uryniak: University grant monies: Donald Tashkin's institution (UCLA) manages research funds received from AstraZeneca, Grant monies (from industry related sources): Donald Tashkin received grant funding from AstraZeneca, Consultant fee, speaker bureau, advisory committee, etc.: Donald Tashkin is a speaker and has served on an advisory committee for AstraZeneca. Bradley Chipps is an advisor or consultant for Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, Merck-Schering, ISTA, Quintiles, and Dey, and is on a speaker bureau forAlcon, Genentech, AstraZeneca, GlaxoSmithKline, Meda, Novartis, Sunovion, Merck-Schering, ISTA, and Dey , Employee: Tom Uryniak, Frank Trudo, and James Zangrilli are employees of AstraZeneca, Shareholder: Tom Uryniak and James Zangrilli are stockholders in AstraZeneca, Other: Bradley Chipps received funding for clinical research from Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, and Merck-Schering, and he received grants for educational activities from Alcon, Genentech, AstraZeneca, GlaxoSmithKline, and Novartis

Frank Trudo: University grant monies: Donald Tashkin's institution (UCLA) manages research funds received from AstraZeneca, Grant monies (from industry related sources): Donald Tashkin received grant funding from AstraZeneca, Consultant fee, speaker bureau, advisory committee, etc.: Donald Tashkin is a speaker and has served on an advisory committee for AstraZeneca. Bradley Chipps is an advisor or consultant for Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, Merck-Schering, ISTA, Quintiles, and Dey, and is on a speaker bureau forAlcon, Genentech, AstraZeneca, GlaxoSmithKline, Meda, Novartis, Sunovion, Merck-Schering, ISTA, and Dey , Employee: Tom Uryniak, Frank Trudo, and James Zangrilli are employees of AstraZeneca, Shareholder: Tom Uryniak and James Zangrilli are stockholders in AstraZeneca, Other: Bradley Chipps received funding for clinical research from Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, and Merck-Schering, and he received grants for educational activities from Alcon, Genentech, AstraZeneca, GlaxoSmithKline, and Novartis

James Zangrilli: University grant monies: Donald Tashkin's institution (UCLA) manages research funds received from AstraZeneca, Grant monies (from industry related sources): Donald Tashkin received grant funding from AstraZeneca, Consultant fee, speaker bureau, advisory committee, etc.: Donald Tashkin is a speaker and has served on an advisory committee for AstraZeneca. Bradley Chipps is an advisor or consultant for Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, Merck-Schering, ISTA, Quintiles, and Dey, and is on a speaker bureau forAlcon, Genentech, AstraZeneca, GlaxoSmithKline, Meda, Novartis, Sunovion, Merck-Schering, ISTA, and Dey , Employee: Tom Uryniak, Frank Trudo, and James Zangrilli are employees of AstraZeneca, Shareholder: Tom Uryniak and James Zangrilli are stockholders in AstraZeneca, Other: Bradley Chipps received funding for clinical research from Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, and Merck-Schering, and he received grants for educational activities from Alcon, Genentech, AstraZeneca, GlaxoSmithKline, and Novartis

This presentation will discuss information about the effects of treatment with budesonide administered via pressurized metered-dose inhaler, which is not an approved formulation in the United States.

University of California Los Angeles, Los Angeles, CA

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