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Allergy and Airway |

Long-term Effects of Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI) in African-American Patients With Moderate to Severe Asthma: Responder Analysis in Patients With Versus Without Fixed Airflow Obstruction (FAO)

Bradley Chipps, MD; Donald P Tashkin, MD; Randall Brown, MD; Tom Uryniak, MS; Frank Trudo, MD
Author and Funding Information

Capital Allergy & Respiratory Disease Center, Sacramento, CA


Chest. 2013;144(4_MeetingAbstracts):83A. doi:10.1378/chest.1703057
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Abstract

SESSION TITLE: Asthma Posters

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM

PURPOSE: The influence of FAO on long-term asthma treatment in African American patients is unclear.

METHODS: This 52-week, randomized, double-blind, phase 3 study (NCT00419952) was conducted in patients with self reported moderate-severe asthma, aged ≥12 years, who were African American (J Allergy Clin Immunol. 2012;130:362-367). The percentage of patients achieving ≥100mL improvement in forced expiratory volume in 1 second (FEV1), ≥100mL improvement in forced vital capacity (FVC), and >0 decrease (inhalations/day) in rescue medication use from baseline to randomized treatment period mean (responders) were stratified by FAO category (screening post albuterol FEV1/FVC ratio <lower limit of normal [LLN][with] or ≥LLN[without]) in the twice-daily BUD/FM pMDI 320/9μg (n=40 [with], n=176 [without]) and BUD pMDI 320μg (n=57 [with]), n=163 [without]) arms after a 2-week run-in on twice-daily BUD pMDI 320µg.

RESULTS: Baseline characteristics suggested a greater degree of impairment and a longer duration of asthma in patients with versus without FAO. In the BUD/FM group, the percentages of patients who met the responder criteria for FEV1, FVC, and rescue medication use were higher in patients with versus without FAO (47.5% vs 45.5%, 47.5% vs 42.0%, and 67.5% vs 62.5%, respectively). The percentages of BUD-treated patients meeting responder criteria for FEV1, FVC, and rescue medication use was similar or higher in patients with versus without FAO were 45.6% vs 23.3%, 35.1% vs 29.4%, and 52.6% vs 56.4%, respectively.

CONCLUSIONS: In this African-American population of patients with moderate to severe asthma, more patients treated with BUD/FM met responder criteria for pulmonary function variables irrespective of the presence of FAO compared with patients treated with BUD.

CLINICAL IMPLICATIONS: Patients with FAO responded as well or better than patients without FAO when treated with BUD/FM or BUD.

DISCLOSURE: Bradley Chipps: Consultant fee, speaker bureau, advisory committee, etc.: Bradley Chipps is a consulting advisor and on the Speaker's Bureau for Genentech, AstraZeneca, GlaxoSmithKline, Novartis, Sunovian, and Merck-Schering, Consultant fee, speaker bureau, advisory committee, etc.: Bradley Chipps is a consulting advisor for SRxA and Dey, Consultant fee, speaker bureau, advisory committee, etc.: Bradley Chipps is on the Speaker's Bureau for Bausch + Lomb Donald P Tashkin: Consultant fee, speaker bureau, advisory committee, etc.: Donald P Tashkin is a consultant/advisor for Pear Therapeutics, Sunovian, Mylan, Novartis, and Theravance, Consultant fee, speaker bureau, advisory committee, etc.: Donald P Tashikin is a speaker for Astra/Zeneca, Forest, Boehringer-Ingelheim, Pfizer, and Novartis, Grant monies (from sources other than industry): Donald P Tashkin received grant monies (administered through the University of California, no personal financial compensation) for Boehringer-Ingelheim, Pearl Therapeutics, Sunovion, Novartis, and GlaxoSmithKline Randall Brown: Other: Randall Brown is an uncompensated Research Advisor for Astra-Zeneca, Consultant fee, speaker bureau, advisory committee, etc.: Randall Brown received honoraria from Merck for a Speakers Panel, Consultant fee, speaker bureau, advisory committee, etc.: Randall Brown received honoraria from Teva for a Speakers Panel and as an Advisor Tom Uryniak: Employee: Tom Uryniak is an employee of AstraZeneca, Shareholder: Tom Uryniak owns stocks/stock options of AstraZeneca Frank Trudo: Employee: Frank Trudo is an employee of AstraZeneca, Shareholder: Frank Trudo owns stocks/stock options of AstraZeneca

No Product/Research Disclosure Information


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