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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 following the 6-week study1. The data show in 24-hour for aclidinium vs placebo from day 1 of treatment1. Significant improvements in vs tiotropium were found on day 1 with comparable vs tiotropium at week 61. In addition, aclidinium was shown to provide statistically significant improvements in 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.

Source

*Patients completed the 14-item EXAcerbations of Chronic pulmonary disease Tool (EXACT) each evening before bedtime via electronic diaries. Responses to 11 of 14 EXACT questions that captured changes in specific respiratory symptoms (grouped into breathlessness, cough and sputum, and chest symptom domains) were used to calculate an EXACT-Respiratory Symptoms (E-RS) total score (range 0-40; a higher score indicates more severe symptoms)1.

Endpoint definitions

-FEV1 – Forced expiratory volume in one second, or the amount of air that can be exhaled in the first second following an inhalation.

-Normalised AUC (0-12 hours, 12-24 hours) FEV1 – Average area under the FEV1 curve over 12 hours, from dosing in the morning until pre-dose twelve hours later (0-12 hours), and from dosing in the evening through the night until pre-dose the next morning (12-24 hours), respectively.

About study LAS391

This was a six-week, randomised, double-blind, double-dummy, placebo and active comparator controlled, parallel multicentre clinical trial1. It assessed the efficacy and safety of twice daily inhaled aclidinium bromide 400μg (equivalent to aclidinium 322µg delivered dose) compared to placebo and to once daily tiotropium 18μg, in 414 patients (mean age 62.3±8.1 years; 54.1% were current smokers; baseline FEV1 was 1.484±0.51L) with moderate-to-severe COPD1.

About aclidinium

Aclidinium is a long-acting inhaled muscarinic receptor antagonist (sometimes referred to as an anticholinergic) that has a longer residence time at M3 receptors than the M2 receptors. Inhaled aclidinium bromide acts locally in the lungs as an antagonist of the M3 receptors on airway smooth muscle and induces bronchodilation4.

The Genuair device includes special mechanisms to help provide feedback to the patient that the medicine is taken correctly5. The feedback mechanisms include: a red/green colour control window to confirm when the medicine is ready for inhalation, an audible click to tell the patient when the dose has been successfully inhaled, a ‘trigger threshold’ mechanism to prevent accidental double dosing and an end-of-dose lockout mechanism to prevent further use of an empty inhaler5.

For further information please consult the Summary of Product Characteristics (SmPC).

References

1 Beier J et al. Efficacy and safety of aclidinium bromide compared with placebo and tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease: results from a 6-week, randomised, controlled phase IIIb study. COPD, 2013; 00:1–12, 2013

2 Scottish Medicines Consortium. July 2013. Accessed from http://www.scottishmedicines.org.uk/

3 MIMS. Eklira Genuair and Spiriva HandiHaler, July 2013

4 Eklira Genuair Summary of Product Characteristics (SmPC)

5 Chrystyn, H et al. The Genuair inhaler: a novel, multidose dry powder inhaler. Int J Clinc Pract, 2012; 66(3):309-17

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