A study to compare 2 treatments for the maintenance of COPD
Research type
Research Study
Full title
A Randomized, Open-Label, 8-Week Cross-Over Study to Compare Umeclidinium/Vilanterol with Tiotropium/Olodaterol Once-Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
IRAS ID
208389
Contact name
Mark Blagden
Contact email
Sponsor organisation
GlaxoSMithKline
Eudract number
2015-000150-38
Duration of Study in the UK
0 years, 8 months, 9 days
Research summary
GSK is conducting a study to compare the efficacy and safety of 2 treatments in subjects with moderate COPD. Both treatments are indicated for the maintenance treatment of COPD and delivered via unique inhalers. The efficacy and safety of both treatments are well known however, a direct comparison of these 2 combinations has not been conducted to further characterize their relative efficacy and safety profiles. In addition; inhaler errors and ease of use of the inhaler devices will be assessed.
During this 8 visit study, subjects with COPD, will be allocated to one of two groups and receive the ELLIPTA device or the Respimat inhaler for 8 weeks each. Eligible subjects will complete a 2 weeks run-in period followed by two 8-week treatment periods, separated by a washout of approximately 3 weeks. A follow-up phone call for side effects and COPD exacerbations will be conducted approximately 1 week after the last clinic visit. Subjects will be provided with rescue salbutamol for use during this study.
Baseline assessments will include; demographic history, medical/disease history, COPD history/exacerbations, pre- and post- salbutamol spirometry (reversibility), physical exam, ECG, urine pregnancy test (if applicable), and a questionnaire on the subjects level of breathlessness.. At all other visits the COPD Assessment Test (CAT) will be performed on a tablet device and the EXACT-PRO (Exacerbations of COPD Tool) questionnaire completed. Adverse events will be recorded.
Subjects will complete the EXACT-PRO and EXACT-RS (Respiratory symptoms) questionnaire daily on an electronic diary plus record use of salbutamol and any adverse events. At 2 visits they will be asked to complete an Inhaler Ease of Use questionnaire and an Inhaler Errors checklist will be completed by the study doctor.
Participants who complete this study will have participated in this study for 22 weeks.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0254
Date of REC Opinion
1 Aug 2016
REC opinion
Further Information Favourable Opinion