ELLIPTA dry powder inhaler (DPI) compared to other DPIs in COPD.
Research type
Research Study
Full title
An open-label, low interventional clinical study investigating error rates (critical and overall) prior to any retraining in correct use of the ELLIPTA dry powder inhaler (DPI) compared to other DPIs including; DISKUS, Turbuhaler, HandiHaler and Breezhaler as a monotherapy or in combination, in adult patients with Chronic Obstructive Pulmonary Disease (COPD).
IRAS ID
224805
Contact name
David Collier
Contact email
Sponsor organisation
GlaxoSmithKline UK pharma
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
This GSK sponsored study is an open-label, low-intervention study which does not involve administration of treatment or placebo.
Screened and confirmed Chronic Obstructive Pulmonary Disease (COPD) patients will attend the clinic for two or three visits; and they will demonstrate the use of their prescribed Dry Powder Inhaler(s) (DPI). This study will investigate the ability of COPD patients to use their prescribed Inhaler(s).
Participants taking part in the study must be using one of the listed Dry Powder Inhalers as their primary treatment:
ELLIPTA (RELVAR ELLIPTA, ANORO ELLIPTA or INCRUSE ELLIPTA)
Turbuhaler (Symbicort Turbuhaler)
DISKUS (Seretide DISKUS)
HandiHaler (Spiriva HandiHaler)
Breezhaler (Ultibro or Seebri Breezhaler)
At Visit 1, participant’s use of their DPIs will be assessed for critical and overall errors. Following error assessment, participants will be instructed in the correct use of their DPI(s) if they have made any errors during their visit, as they would in general/primary care practice. If the participant has used their DPI correctly, they will not receive any instruction on correct use for that DPI, but will be informed of their correct use. If the participant is prescribed a Metered Dose Inhaler (MDI) for rescue therapy, they will have their use of this device assessed as well.
6 weeks after Visit 1, plus or minus 7 days, participants will attend the clinic for Visit 2 and they will be reassessed for errors made during use of their DPI. Any changes in health and prescriptions will be captured. 6 weeks was chosen as deemed long enough to establish if any retraining is required, or if no training was required, if correct use is maintained. Upon completion of the assessments at Visit 2, the participant will have completed the study.
Participants will be paid £250 for their participation in the study and their travel expenses will be reimbursed.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0174
Date of REC Opinion
23 May 2017
REC opinion
Further Information Favourable Opinion