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*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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12 Jul. 2013.
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