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Obstructive Lung Diseases |

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

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

Capital Allergy & Respiratory Disease Center, Sacramento, CA


Chest. 2012;142(4_MeetingAbstracts):700A. doi:10.1378/chest.1386417
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Abstract

SESSION TYPE: Asthma Posters

PRESENTED ON: Wednesday, October 24, 2012 at 01:30 PM - 02:30 PM

PURPOSE: To assess the incidence of fixed airflow obstruction (FAO) and its effect on asthma treatment response.

METHODS: Data were from a 12-week, randomized, double-blind study (NCT00651651) in patients ≥12 years with mild-moderate asthma (Clin Ther.2007;29:823-43). 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 included twice-daily BUD/FM pMDI 160/9μg (LLN:with[n=25],without[n=98]; 0.70:with[n=17],without[n=112]); BUD pMDI 160μg (LLN:with[n=28],without[n=91]; 0.70:with[n=20],without[n=107]); FM DPI 9μg (LLN:with[n=29],without[n=89]; 0.70:with[n=16],without[n=105]); placebo (LLN:with[n=34],without[n=93]; 0.70:with[n=24],without[n=107]).

RESULTS: Approximately 25% of patients met either FAO criterion. Patients with versus without FAO (LLN definition) were older (36.5y vs 34.4y), more likely male (45.7% vs 37.7%), and had longer asthma duration (23.5y vs 17.7y); results were similar using the 0.70 definition. Study withdrawal in patients with versus without FAO (LLN): Any Reason (placebo, 58.8% vs 46.2%; FM, 37.9% vs 29.2%; BUD, 21.4% vs 14.3%; BUD/FM, 8.0% vs 18.4%); Due to Predefined Asthma Event (placebo, 38.2% vs 29.0%; FM, 27.6% vs 19.1%; BUD, 14.3% vs 4.4%; BUD/FM, 4.0% vs 9.2%). Improvements in asthma control days with versus without FAO (LLN): placebo, 4.1% vs 7.8%; FM, 7.4% vs 12.9%; BUD, 15.9% vs 22.6%; BUD/FM, 23.4% vs 21.0%. Overall results were similar using the 0.70 definition.

CONCLUSIONS: The response to BUD/FM pMDI, including fewer withdrawals and more asthma control days, was generally greater in patients with versus without FAO and more robust than for BUD, FM, or placebo.

CLINICAL IMPLICATIONS: The presence of FAO, defined based on an FEV1/FVC ratio <LLN or <0.70, identified patients at increased risk for poorer asthma control relative to those not meeting FAO criteria. Patients with mild to moderate asthma with FAO retained a positive controller response to BUD/FM.

DISCLOSURE: 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 has served as an advisor or consultant for Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, Merck-Schering, ISTA, Quintiles, and Dey, and has been on a speaker bureau for Alcon, 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

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 has served as an advisor or consultant for Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, Merck-Schering, ISTA, Quintiles, and Dey, and has been on a speaker bureau for Alcon, 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 has served as an advisor or consultant for Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, Merck-Schering, ISTA, Quintiles, and Dey, and has been on a speaker bureau for Alcon, 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 has served as an advisor or consultant for Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, Merck-Schering, ISTA, Quintiles, and Dey, and has been on a speaker bureau for Alcon, 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 has served as an advisor or consultant for Alcon, Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovion, Merck-Schering, ISTA, Quintiles, and Dey, and has been on a speaker bureau for Alcon, 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.

Capital Allergy & Respiratory Disease Center, Sacramento, CA

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