Eklira® Genuair® Provides Significant Improvements In COPD Symptoms Vs Placebo In A 6-Week Study
New Phase IIIb data published in the journal COPD demonstrates comparable efficacy for twice-daily Eklira® Genuair® (aclidinium) vs tiotropium following the 6-week study1. The data show significant improvements in 24-hour bronchodilation for aclidinium vs placebo from day 1 of treatment1. Significant improvements in bronchodilation vs tiotropium were found on day 1 with comparable bronchodilation vs tiotropium at week 61. In addition, aclidinium was shown to provide statistically significant improvements in COPD symptoms throughout the morning, day and night, compared to placebo that were numerically greater than achieved with tiotropium1.
The study investigated the efficacy of inhaled aclidinium 400μg (equivalent to aclidinium 322µg delivered dose) twice-daily compared to placebo, and tiotropium 18μg once daily, in 414 patients with stable moderate-to-severe COPD, over a 6-week period1. The effects of treatment on COPD symptoms, inhaler preference and safety were also evaluated1.
Aclidinium met the primary endpoint (change from baseline in normalised FEV1 AUC0-24 at week 6) showing a clinically meaningful and statistically significant improvement (p<0.0001) vs placebo1. The differences in FEV1 AUC0-24 were statistically significant with aclidinium vs tiotropium (p<0.05 and p<0.01) on day 1 and comparable for aclidinium vs tiotropium at week 61.
Secondary and additional endpoints included FEV1 AUC12-24, COPD symptoms (EXAcerbations of Chronic pulmonary disease Tool-Respiratory Symptoms [EXACT-RS] total scores*), additional symptoms and safety1. The EXACT-RS total scores were significantly reduced from baseline with both aclidinium (p<0.0001) and tiotropium (p<0.05) vs placebo1 and, over the 6 weeks, there was a significant increase in relief medication-free days with aclidinium and tiotropium vs placebo (p<0.05)1. Only aclidinium significantly reduced the severity of early-morning cough, wheeze, shortness of breath and phlegm compared to placebo at week 6. Night-time symptom severity scores vs placebo were also significantly reduced from baseline in patients who received aclidinium (p<0.05), but not in those who received tiotropium1.
Significantly more patients were found to prefer the Genuair® device compared to HandiHaler® (tiotropium) (80.1% vs 10.7%; p<0.0001) and patients were more willing to continue using Genuair® than HandiHaler®, as indicated by a significant difference in mean scores at week 6 (88.8 vs 45.4; p<0.0001)1.
"Until recently, tiotropium was the only available LAMA for the treatment of COPD. These results are important as they show that aclidinium is a viable treatment alternative which provides comparable efficacy to tiotropium and also addresses the important issue of night-time and morning symptoms in COPD patients. The Genuair® device has been shown in this study to be easy to use. Aclidinium may therefore contribute to better treatment outcomes and improved quality of life for these patients" said Professor Paul Jones, Professor of Respiratory Medicine and Head of the Division of Clinical Science at St George's, University of London.
Aclidinium was generally well tolerated1. The most frequently reported adverse events included headache (7.0%) and nasopharyngitis (5.8%). Other common adverse events include COPD exacerbation and cough[i].
Aclidinium was launched in the UK in September 2012, and was recently accepted for use by the Scottish Medicine Consortium as a twice-daily maintenance treatment to relieve symptoms in adult patients with COPD2. Aclidinium costs £28.60 - saving 18% on the cost of treatment initiation vs traditional LAMA treatment by the HandiHaler3.