Clinical trial NCT03467425: INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: FF/VI/UMEC
TRELEGY ELLIPTA
COPD
Effectiveness
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-03-16
Enrollment: 3109
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized in a ratio of 1:1 to receive one of the following study treatment regimens: TRELEGY ELLIPTA once daily in the morning or Non-ELLIPTA MITT twice-daily treatment.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Capable of giving signed informed consent.
* Subjects with a documented physician diagnosis of COPD.
* A score of \>=10 on the CAT at screening.
* Subjects who have a history of treatment with systemic/oral corticosteroids, antibiotics and/or hospitalization for at least one COPD exacerbation in the 3 years prior to randomization. This will be captured through subject recall and/or medical records and must be documented in subject's notes. Prior use of systemic/oral corticosteroids and/or antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD.
* Subjects currently receiving one of the non-ELLIPTA maintenance therapies listed below who have been prescribed it continually for at least 16 weeks prior to randomization. Continuous prescription is defined as a minimum of 60 days' prescription cover during the prior 16 weeks. The non-ELLIPTA maintenance therapy must be one of the following: Inhaled Corticosteroid (ICS) in combination with Long-acting Muscarinic Receptor Antagonist (LAMA) and Long Acting Beta-Agonist (LABA) (MITT) or LAMA and LABA used in combination as a dual therapy or LABA and ICS used in combination as a dual therapy. Subjects who are currently on a dual maintenance therapy for COPD must be considered by their physician to require a step-up to triple therapy. The reason for the physician decision to step- up must be documented. Subjects who are receiving only COPD medication on an 'as required' basis are not eligible.
* Subjects must be aged \>=40 years of age at the time of signing the informed consent.

Exclusion Criteria:

* Women of child bearing potential: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
* Subjects with any life-threatening condition i.e. low probability, in the opinion of the investigator, of 6-month survival due to severity of COPD or comorbid condition.
* Subjects with resolution of an exacerbation less than 2 weeks prior to visit 1, must not be randomized. Subjects may be rescreened 2 weeks after resolution of exacerbation (exacerbation is defined by treatment with systemic corticosteroids and/or antibiotic).
* Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the effectiveness or safety analysis if the disease/condition exacerbated during the study.
* A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator contraindicates study participation.
* Subjects who, in the opinion of the treating investigator, are chronic users of oral corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening). Chronic use is defined as more than 14 days continuous use during the 12 weeks prior to visit 1.
* Subjects taking any investigational drug treatment within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study (whichever is the longer of the two).

Primary outcomes:
measure: Number of Responders and Non-responders Based on the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 24 and Number of Participants With Imputed CAT Score at Week 24
timeFrame: At Week 24
Secondary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24
timeFrame: Baseline (Day 1) and at Week 24
measure: Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24
timeFrame: At Week 24
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Dachau
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Garmisch-Partenirchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wallerfing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Cottbus
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Fuerstenwalde
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Ruedersdorf
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Darmstadt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Fulda
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Marburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Rodgau
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Ruesselsheim
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Peine
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Wardenburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bergisch Gladbach
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Gelsenkirchen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Rheine
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Warendorf
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Teuchern
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Delitzsch
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Geesthacht
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Schleswig
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Schmoelln
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Deggendorf
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Alkmaar
country: Netherlands
facility: GSK Investigational Site
city: Breda
country: Netherlands
facility: GSK Investigational Site
city: Dordrecht
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Harderwijk
country: Netherlands
facility: GSK Investigational Site
city: Heerlen
country: Netherlands
facility: GSK Investigational Site
city: Hengelo
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facility: GSK Investigational Site
city: Hoorn
country: Netherlands
facility: GSK Investigational Site
city: Kloosterhaar
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facility: GSK Investigational Site
city: Nijmegen
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facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Zeist
country: Netherlands
facility: GSK Investigational Site
city: Zutphen
country: Netherlands
facility: GSK Investigational Site
city: Marbella - Málaga
country: Spain
facility: GSK Investigational Site
state: Andalucia
city: Laredo
country: Spain
facility: GSK Investigational Site
state: Cantabria
city: Torrejón de Ardoz
country: Spain
facility: GSK Investigational Site
state: Madrid
city: Alcorcón (Madrid)
country: Spain
facility: GSK Investigational Site
city: Alzira/Valencia
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Basurto/Bilbao
country: Spain
facility: GSK Investigational Site
city: Benalmádena, Málaga
country: Spain
facility: GSK Investigational Site
city: Caceres
country: Spain
facility: GSK Investigational Site
city: Cádiz
country: Spain
facility: GSK Investigational Site
city: L'Hospitalet De Llobregat. Barcelona
country: Spain
facility: GSK Investigational Site
city: La Roca Del Valles (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Logroño
country: Spain
facility: GSK Investigational Site
city: Loja/ Granada
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Ponferrada (León)
country: Spain
facility: GSK Investigational Site
city: Pozuelo De Alarcón/Madrid
country: Spain
facility: GSK Investigational Site
city: Segovia
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Vigo-Pontevedra
country: Spain
facility: GSK Investigational Site
city: Zaragoza
country: Spain
facility: GSK Investigational Site
city: Angered
country: Sweden
facility: GSK Investigational Site
city: Flen
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Göteborg
country: Sweden
facility: GSK Investigational Site
city: Härnösand
country: Sweden
facility: GSK Investigational Site
city: Höllviken
country: Sweden
facility: GSK Investigational Site
city: Kristianstad
country: Sweden
facility: GSK Investigational Site
city: Kungsbacka
country: Sweden
facility: GSK Investigational Site
city: Luleå
country: Sweden
facility: GSK Investigational Site
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Motala
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Södertälje
country: Sweden
facility: GSK Investigational Site
city: Trollhättan
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
city: Östersund
country: Sweden
facility: GSK Investigational Site
city: Soham
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
city: Llanelli
country: United Kingdom
facility: GSK Investigational Site
state: Carmarthenshire
city: Bollington
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Macclesfield
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Sandbach
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Rhyl
country: United Kingdom
facility: GSK Investigational Site
state: Denbighshire
city: Waterlooville
country: United Kingdom
facility: GSK Investigational Site
state: Hampshire
city: Wishaw
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Corby
country: United Kingdom
facility: GSK Investigational Site
state: Northamptonshire
city: Wellingborough
country: United Kingdom
facility: GSK Investigational Site
state: Northamptonshire
city: Leiston
country: United Kingdom
facility: GSK Investigational Site
state: Suffolk
city: Bexhill
country: United Kingdom
facility: GSK Investigational Site
state: Sussex East
city: Gateshead
country: United Kingdom
facility: GSK Investigational Site
state: Tyne & Wear
city: Bebington
country: United Kingdom
facility: GSK Investigational Site
city: Buckley
country: United Kingdom
facility: GSK Investigational Site
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
city: Cardiff
country: United Kingdom
facility: GSK Investigational Site
city: Colchester
country: United Kingdom
facility: GSK Investigational Site
city: Corbridge
country: United Kingdom
facility: GSK Investigational Site
city: Cornwall
country: United Kingdom
facility: GSK Investigational Site
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
city: Hull
country: United Kingdom
facility: GSK Investigational Site
city: Irlam, Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Larbet
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Newport, Isle Of Wight
country: United Kingdom
facility: GSK Investigational Site
city: Newport
country: United Kingdom
facility: GSK Investigational Site
city: Poole
country: United Kingdom
facility: GSK Investigational Site
city: Southampton
country: United Kingdom
facility: GSK Investigational Site
city: Swinton
country: United Kingdom
facility: GSK Investigational Site
city: Warrington
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Worsley S, Snowise N, Halpin DMG, Midwinter D, Ismaila AS, Irving E, Sansbury L, Tabberer M, Leather D, Compton C. Clinical effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol in usual practice: the COPD INTREPID study design. ERJ Open Res. 2019 Nov 4;5(4):00061-2019. doi: 10.1183/23120541.00061-2019. eCollection 2019 Oct.