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Inhaled Combination Therapy for COPD: A Once-a-Day Alternative?


August 20, 2012 — A combination of fluticasone furoate and vilanterol (FF/VI) inhaled once daily improves pulmonary function and has a duration of action of longer than 24 hours, according to the findings of a new study published in the August issue of Clinical Therapeutics.
The phase 3 multicenter study, led by Joseph A. Boscia, MD, from CU Pharmaceutical Research, Union, South Carolina, included 54 patients randomly assigned to "1 of 18 three-course sequences of placebo and 2 of 3 dose combinations of FF/VI (50/25 μg, 100/25 μg, and 200/25 μg), dosed once daily in the morning."
The researchers found that all 3 strengths of FF/VI showed improvement in forced expiratory volume in 1 second (FEV1) compared with placebo: adjusted mean improvements from baseline for FF/VI were 220 to 236 mL (all, P < .001). Improvements in serial FEV1 measurements were observed at each time from 0 to 25 hours and with each strength of drug compared with placebo.
Adverse events reported were 10% to 12% with FF/VI vs 4% with placebo, and systemic exposure to FF and VI was low for all strengths of the drug.
"This is the first study to evaluate the 24-hour spirometric effect of different doses of FF added to VI (FF/VI 50/25 μg, 100/25 μg, and 200/25 μg) after 28 days of once-daily treatment in patients with [chronic obstructive pulmonary disease (COPD)]," Dr. Boscia and colleagues write.
The researchers enrolled patients between January 27 and July 1, 2010. In addition to a documented history of COPD, eligible patients had "a post-bronchodilator [FEV1] of ≤70% predicted and a FEV1/forced vital capacity ratio of ≤0.70; a current habit or history of ≥10 pack-years of cigarette smoking; and a score of ≥2 (on a scale of 1–4) on the Modified Medical Research Council Dyspnea Scale." Over half (63%) of patients enrolled were receiving short-acting β2-agonists at enrollment, and 83% were current smokers.
Patients completed a 2-week placebo run-in period before randomization to treatment groups and had an average age of 57.9 years. Patients in each group were treated for 28 days, separated by a 2-week, single-blind, placebo washout period. Predose spirometry was performed at each visit after withholding other respiratory medications and refraining from smoking for 1 hour or more. At the end of each treatment period, the time-adjusted 0- to 24-hours FEV1 was evaluated as the primary endpoint. Systemic exposure was assessed by measuring plasma levels of FF and VI collected 24 hours' postdose over days 28 and 29.
"The combination FF/VI administered once daily in the morning for 28 days was well tolerated and associated with statistically significant improvements in pulmonary function with a prolonged (>24 hours') duration of action in this population of patients with COPD," the study authors conclude.
Asked for independent comment from Medscape Medical News, a spokesperson from the US Department of Veterans Affairs (VA), Washington, DC, said, "As adherence is a significant problem in inhaler use in COPD, potentially once-a-day inhalers might improve adherence, but likely at a significant cost, since both agents are likely under patent."
The VA spokesperson added, "Since use of long-acting beta agonists and muscarinic antagonists are associated with reduced exacerbations, it is conceivable that these drugs also might be associated with reduced exacerbations, [but the] effect of these long-acting agents on healthcare utilization and/or exacerbations has not been determined."
The study was supported by GlaxoSmithKline. Dr. Boscia is on the speakers' bureau of GlaxoSmithKline. Dr. Boscia and 1 other coauthor were principal investigators on this clinical trial and are employed by the study administrators. The other coauthors are employees of GlaxoSmithKline. The commentator has disclosed no relevant financial relationships.

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