NCT03467425

INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design

The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in a Single Inhaler (TRELEGY™ ELLIPTA™) When Compared With Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients Within a Usual Care Setting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,109 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary Disease (COPD) control within the usual clinical practice setting. The study will be conducted once TRELEGY ELLIPTA has been approved in the countries in which the study will be conducted and is available commercially. This is a randomized, open-label, effectiveness, phase 4 study of 24 weeks' duration in COPD subjects to evaluate TRELEGY ELLIPTA (fluticasone furoate \[FF\]/vilanterol \[VI\]/umeclidinium bromide \[UMEC\]: 100 microgram \[mcg\]/62.5 mcg/25 mcg) inhalation powder taken once daily using a single ELLIPTA inhaler compared with any non-ELLIPTA MITT in the usual care setting. Effectiveness of TRELEGY ELLIPTA will be assessed by comparing proportion of COPD Assessment Test (CAT) responders at Week 24 between two treatment groups. TRELEGY and ELLIPTA are trademarks of GlaxoSmithKline (GSK) group of companies. The study will enroll approximately 3000 subjects.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	FF/UMEC/VI	FF is a dry white powder containing 100 mcg GW685698 blended with lactose in one blister in the first strip of the DPI. UMEC/VI is a dry white powder containing 62.5 mcg of UMEC and 25 mcg of VI per blister, both blended together with lactose and magnesium stearate in the second strip of the DPI.
DRUG	Inhaled Corticosteroid	Inhaled Corticosteroid (ICS) as prescribed by the physician.
DRUG	LAMA	LAMA as prescribed by the physician.
DRUG	LABA	LABA as prescribed by the physician.
DRUG	COPD rescue medications	Rescue medications for COPD will be prescribed and obtained according to usual practice.

Timeline

• Start date: 2018-04-11
• Primary completion: 2019-10-10
• Completion: 2019-10-10
• First posted: 2018-03-16
• Last updated: 2020-09-07
• Results posted: 2020-09-07

Locations

143 sites across 5 countries: Germany, Netherlands, Spain, Sweden, United Kingdom