NCT03114969

Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 450 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

For effective drug delivery using inhalation route, it is important to use the inhalers correctly. This open-label study will evaluate the error rates during the use of ELLIPTA DPI, alone or in combination, in comparison with other DPIs. The study aims to provide clinical evidence in subjects with COPD that the reduced number of steps required to use the ELLIPTA DPI could result in fewer errors made by subjects, and therefore a more consistent treatment. Approximately 450 subjects prescribed with either of RELVAR® ELLIPTA, ANORO® ELLIPTA, INCRUSE® ELLIPTA, SYMBICORT® TURBUHALER®, SERETIDE® DISKUS®, SPIRIVA® HANDIHALER®, ULTIBRO® BREEZHALER® or SEEBRI® BREEZHALER will be included in the study and will have 2 clinical visits. At Visit 1, subjects will take their maintenance DPIs and the critical and overall errors made by subjects will be assessed. After the assessment, subjects will be instructed on correct use or informed of their correct use of their DPIs. The total duration of the study is approximately 6 weeks. ELLIPTA, SERETIDE and DISKUS are registered trademarks of the GSK group of companies. SYMBICORT and TURBUHALER are registered trademarks of the AstraZeneca group of companies. SPIRIVA and HANDIHALER are registered trademarks of Boehringer Ingelheim Pharmaceuticals. ULTIBRO, BREEZHALER and SEEBRI are registered trademarks of the Novartis group of companies.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DEVICE	Relvar ELLIPTA	ELLIPTA inhaler containing Relvar will be used by subjects as their maintenance treatment to control COPD.
DEVICE	Symbicort TURBUHALER	TURBUHALER inhaler containing Symbicort will be used by subjects as their maintenance treatment to control COPD.
DEVICE	Seretide DISKUS	DISKUS inhaler containing Seretide will be used by subjects as their maintenance treatment to control COPD.
DEVICE	Spiriva HANDIHALER	HANDIHALER inhaler containing Spiriva will be used by subjects as their maintenance treatment to control COPD.
DEVICE	BREEZHALER	BREEZHALER inhaler containing either Seebri or Ultibro will be used by subjects as their maintenance treatment to control COPD.
DEVICE	Incruse ELLIPTA	ELLIPTA inhaler containing Incruse will be used by subjects as their maintenance treatment to control COPD.
DEVICE	Anoro ELLIPTA	ELLIPTA inhaler containing Anoro will be used by subjects as their maintenance treatment to control COPD.

Timeline

• Start date: 2017-06-08
• Primary completion: 2018-03-09
• Completion: 2018-03-09
• First posted: 2017-04-14
• Last updated: 2020-10-28
• Results posted: 2019-06-10

Locations

13 sites across 2 countries: Netherlands, United Kingdom