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Allergy and Airway |

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

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

University of California Los Angeles, Los Angeles, CA


Chest. 2013;144(4_MeetingAbstracts):79A. doi:10.1378/chest.1704580
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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 patients previously treated with inhaled corticosteroids is unclear.

METHODS: This 52-week, double-blind, safety study (NCT00651768) was conducted in moderate-severe patients with asthma aged ≥12 years previously treated with inhaled corticosteroids (Allergy Asthma Proc. 2008;29:499-516). The percentage of patients achieving ≥100mL improvement in forced expiratory volume in 1 second (FEV1), ≥100mL improvement in forced vital capacity (FVC), and ≥0.5 decrease (inhalations/d) 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 640/18μg (n=83[with], n=126[without]), the twice-daily BUD/FM pMDI 320/9μg (n=22[with], n=26[without]), and twice-daily BUD pMDI 640μg (n=27[with]), n=48[without]) arms after a 2-week run-in on twice-daily BUD pMDI 320μg.

RESULTS: Baseline characteristics suggested a greater degree of impairment in patients with versus without FAO. In the BUD/FM 640/18µg group, the percentages of patients who met responder criteria for FEV1, FVC, and rescue medication use were similar or slightly higher in patients with versus without FAO (63.9% vs 63.5%, 53.0% vs 50.8%, and 55.4% vs 38.1%, respectively). In the BUD/FM 320/9µg group, the percentages of patients who met responder criteria for FEV1 and FVC were higher in patients with versus without FAO (72.7% vs 65.4% and 68.2% vs 61.5%, respectively) and the same for rescue medication use (50.0%). The percentages of BUD-treated patients meeting responder criteria for FEV1 were higher in patients with versus without FAO (40.7% vs 35.4%) but lower for FVC and rescue medication use (33.3% vs 37.5%, 33.3% vs 35.4%, respectively).

CONCLUSIONS: Fifty percent or more of BUD/FM-treated patients with or without FAO met responder criteria across multiple control metrics. A similar or numerically higher proportion of those with vs without FAO met responder criteria.

CLINICAL IMPLICATIONS: The percentage of patients with or without FAO meeting response criteria for FEV1, FVC, and rescue medication use was greater in BUD/FM- vs BUD-treated patients.

DISCLOSURE: Donald Tashkin: Consultant fee, speaker bureau, advisory committee, etc.: Pearl Therapeutics, Sunovion, Mylan, Novartis, Theravance, Consultant fee, speaker bureau, advisory committee, etc.: Astra/Zeneca, Forest, Boehringer-Ingelheim, Pfizer, University grant monies: no personal financial compensation: Boehringer-Ingelheim, Pearl Therapeutics, Sunovion, Novartis, GlaxoSmithKline Bradley Chipps: Consultant fee, speaker bureau, advisory committee, etc.: Genentech, AstraZeneca, GlaxoSmithKline, SRxA, Novartis, Sunovion, Merck-Schering, Bausch + Lomb, Dey Randall Brown: Consultant fee, speaker bureau, advisory committee, etc.: Merck, Teva, Other: Uncompensated research advisor for AstraZeneca Tom Uryniak: Shareholder: AstraZeneca LP, Employee: AstraZeneca LP Frank Trudo: Shareholder: AstraZeneca LP, Employee: AstraZeneca LP

Regarding the question of off-label use, as I noted in an earlier e-mail, the safety study results reported in the abstract include findings obtained in subjects receiving twice the approved dose of BUD/FORM. However, this dose was evaluated only with regard to the safety of the product.


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