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Last Updated: July 15, 2020

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CLINICAL TRIALS PROFILE FOR TRELEGY ELLIPTA

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All Clinical Trials for TRELEGY ELLIPTA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03467425 INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design Recruiting GlaxoSmithKline Phase 4 2018-04-11 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.
NCT03949842 Legend: TRELEGY Real World Chronic Obstructive Pulmonary Disease (COPD) Effectiveness Study Not yet recruiting GlaxoSmithKline Phase 4 2019-06-14 The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA single inhaler triple therapy (SITT) (fluticasone furoate/umeclidinium bromide/vilanterol [FF/UMEC/VI]) relative to non-ELLIPTA multiple inhaler triple therapies (MITT) of inhaled corticosteroids/long-acting beta2-adrenergic receptor agonists/muscarinic receptor antagonists (ICS/LABA/LAMA) within a routine clinical practice setting. This is a non-randomized, interventional and self-controlled cohort study conducted to collect data in routine practice. This study will have two periods where in retrospective data will be collected in pre-switch period and prospective data will be collected in post-switch periods. Subjects will be switched from non-ELLIPTA MITT to TRELEGY ELLIPTA. The pre-switch period is of 52 weeks and post-switch period will be of 52 weeks. Additionally subjects will receive safety follow-up call at 26 weeks and 52 weeks for safety monitoring. Approximately 1300 subjects will be enrolled for this study. TRELEGY ELLIPTA is a registered trademark of the GlaxoSmithKline (GSK) group of companies.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TRELEGY ELLIPTA

Condition Name

Condition Name for TRELEGY ELLIPTA
Intervention Trials
Pulmonary Disease, Chronic Obstructive 2
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Condition MeSH

Condition MeSH for TRELEGY ELLIPTA
Intervention Trials
Pulmonary Disease, Chronic Obstructive 2
Lung Diseases 2
Chronic Disease 2
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Clinical Trial Locations for TRELEGY ELLIPTA

Trials by Country

Trials by Country for TRELEGY ELLIPTA
Location Trials
Germany 11
United Kingdom 8
Sweden 1
Netherlands 1
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Clinical Trial Progress for TRELEGY ELLIPTA

Clinical Trial Phase

Clinical Trial Phase for TRELEGY ELLIPTA
Clinical Trial Phase Trials
Phase 4 2
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Clinical Trial Status

Clinical Trial Status for TRELEGY ELLIPTA
Clinical Trial Phase Trials
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for TRELEGY ELLIPTA

Sponsor Name

Sponsor Name for TRELEGY ELLIPTA
Sponsor Trials
GlaxoSmithKline 2
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Sponsor Type

Sponsor Type for TRELEGY ELLIPTA
Sponsor Trials
Industry 2
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