CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 450 enrolled
Drug / intervention
Relvar ELLIPTA +6 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03114969
NCT03114969N/ACompleted

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)

GlaxoSmithKline·observational·Posted Apr 14, 2017·Updated Oct 28, 2020

In Brief

An observational study evaluating Relvar ELLIPTA, Symbicort TURBUHALER, and 5 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 450 participants across 13 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 14, 2017
Enrollment StartJun 8, 2017
Primary CompletionMar 9, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 9.2 years ago

Interventions

Relvar ELLIPTAdevice

ELLIPTA inhaler containing Relvar will be used by subjects as their maintenance treatment to control COPD.

Symbicort TURBUHALERdevice

TURBUHALER inhaler containing Symbicort will be used by subjects as their maintenance treatment to control COPD.

Seretide DISKUSdevice

DISKUS inhaler containing Seretide will be used by subjects as their maintenance treatment to control COPD.

Spiriva HANDIHALERdevice

HANDIHALER inhaler containing Spiriva will be used by subjects as their maintenance treatment to control COPD.

BREEZHALERdevice

BREEZHALER inhaler containing either Seebri or Ultibro will be used by subjects as their maintenance treatment to control COPD.

Incruse ELLIPTAdevice

ELLIPTA inhaler containing Incruse will be used by subjects as their maintenance treatment to control COPD.

Anoro ELLIPTAdevice

ELLIPTA inhaler containing Anoro will be used by subjects as their maintenance treatment to control COPD.