Relvar Ellipta in Patients with COPD and Asthma
Research type
Research Study
Full title
Evaluating the Impact, Benefits and Preferences of Relvar® Ellipta® in Patients with COPD and Asthma
IRAS ID
206320
Contact name
Lisa M Bradshaw
Contact email
Sponsor organisation
GlaxoSmithKline
Duration of Study in the UK
0 years, 4 months, 9 days
Research summary
Existing treatments for asthma and COPD are typically twice daily inhaled treatments. Relvar has been recently launched by GSK as a new, combined medicine in the maintenance treatment of COPD and asthma. One of the main features of it is 24-hour continuous efficacy and, as such, it is the first and only once-daily inhaled combination available. Relvar is delivered via an easy to use and patient preferred inhaler device called Ellipta®.
The current study aims to collect data on patients’ experiences with Relvar and how this compares with previous treatments (where appropriate/relevant). Previous research has demonstrated that patients find Ellipta easy to use, and as a once daily medication, this is likely to result in greater convenience on behalf of the patients. A 24-hour continuous efficacy profile may also lead to fewer symptoms at night, consequently improve sleep quality and reduce fatigue, with potential benefits of greater productivity and ability to conduct various activities. However, other treatment impacts may arise during the course of this research that are unknown or difficult to predict at this stage. Other treatment impacts, benefits/disadvantages, preferences and satisfaction/dissatisfaction of using Relvar® Ellipta® will be investigated during qualitative patient interviews and may include greater frequency of rescue mediation use, symptom-free 24-hour periods and lower levels of anxiety. In addition, any unanticipated adverse effects of this once daily medication may also be identified.
Data from the semi-structured patient interviews will be used to inform and develop a quantitative survey, which will be used to measure the extent to which Relvar® Ellipta® patients are satisfied with their treatment based on the impacts of Relvar® Ellipta® highlighted in the qualitative interviews.REC name
London - South East Research Ethics Committee
REC reference
16/LO/0836
Date of REC Opinion
20 Jun 2016
REC opinion
Further Information Favourable Opinion