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INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design

NCT ID: NCT03467425

Last Updated: 2020-09-07

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-11

Study Completion Date

2019-10-10

Brief Summary

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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.

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A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC /VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TRELEGY ELLIPTA (FF/UMEC/VI: 100 mcg/62.5 mcg/25 mcg)

Eligible subjects will receive a blended combination of FF in the first strip (100 mcg per blister) and UMEC/VI in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the morning in the same TRELEGY ELLIPTA Dry Powder Inhaler (DPI) via inhalation route for a period of 24 weeks. Study treatment may be augmented with other prescribed COPD medications such as including rescue medications, which will be prescribed and obtained according to usual practice.

Group Type EXPERIMENTAL

FF/UMEC/VI

Intervention Type DRUG

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.

COPD rescue medications

Intervention Type DRUG

Rescue medications for COPD will be prescribed and obtained according to usual practice.

Non-ELLIPTA MITT

Eligible subjects will receive the ICS/LAMA/LABA products twice daily and dosing regimens as prescribed by their physician for a period of 24 weeks. Study treatment may be augmented with other prescribed COPD medications such as including rescue medications, which will be prescribed and obtained according to usual practice.

Group Type ACTIVE_COMPARATOR

Inhaled Corticosteroid

Intervention Type DRUG

Inhaled Corticosteroid (ICS) as prescribed by the physician.

LAMA

Intervention Type DRUG

LAMA as prescribed by the physician.

LABA

Intervention Type DRUG

LABA as prescribed by the physician.

COPD rescue medications

Intervention Type DRUG

Rescue medications for COPD will be prescribed and obtained according to usual practice.

Interventions

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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.

Intervention Type DRUG

Inhaled Corticosteroid

Inhaled Corticosteroid (ICS) as prescribed by the physician.

Intervention Type DRUG

LAMA

LAMA as prescribed by the physician.

Intervention Type DRUG

LABA

LABA as prescribed by the physician.

Intervention Type DRUG

COPD rescue medications

Rescue medications for COPD will be prescribed and obtained according to usual practice.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Aschaffenburg, Bavaria, Germany

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Dachau, Bavaria, Germany

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Garmisch-Partenirchen, Bavaria, Germany

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Wallerfing, Bavaria, Germany

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Cottbus, Brandenburg, Germany

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Fürstenwalde, Brandenburg, Germany

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Potsdam, Brandenburg, Germany

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Potsdam, Brandenburg, Germany

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Rüdersdorf, Brandenburg, Germany

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Darmstadt, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Fulda, Hesse, Germany

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Marburg, Hesse, Germany

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Rodgau, Hesse, Germany

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Rüsselsheim am Main, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Hanover, Lower Saxony, Germany

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Peine, Lower Saxony, Germany

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Wardenburg, Lower Saxony, Germany

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Bergisch Gladbach, North Rhine-Westphalia, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Gelsenkirchen, North Rhine-Westphalia, Germany

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Rheine, North Rhine-Westphalia, Germany

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Warendorf, North Rhine-Westphalia, Germany

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Koblenz, Rhineland-Palatinate, Germany

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Delitzsch, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Teuchern, Saxony-Anhalt, Germany

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Geesthacht, Schleswig-Holstein, Germany

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Lübeck, Schleswig-Holstein, Germany

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Schleswig, Schleswig-Holstein, Germany

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Schmölln, Thuringia, Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Deggendorf, , Germany

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Hamburg, , Germany

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Alkmaar, , Netherlands

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Breda, , Netherlands

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Dordrecht, , Netherlands

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Groningen, , Netherlands

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Groningen, , Netherlands

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Harderwijk, , Netherlands

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Heerlen, , Netherlands

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Hengelo, , Netherlands

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Hoorn, , Netherlands

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Kloosterhaar, , Netherlands

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Rotterdam, , Netherlands

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Rotterdam, , Netherlands

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Zeist, , Netherlands

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Zutphen, , Netherlands

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Marbella - Málaga, Andalusia, Spain

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Laredo, Cantabria, Spain

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Torrejón de Ardoz, Madrid, Spain

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Alcorcón (Madrid), , Spain

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Alzira/Valencia, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Basurto/Bilbao, , Spain

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Benalmádena, Málaga, , Spain

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Cadiz, , Spain

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Cáceres, , Spain

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L'Hospitalet de Llobregat. Barcelona, , Spain

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La Roca Del Valles (Barcelona), , Spain

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Logroño, , Spain

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Loja/ Granada, , Spain

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Madrid, , Spain

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Palma de Mallorca, , Spain

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Ponferrada (León), , Spain

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Pozuelo de Alarcón/Madrid, , Spain

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Segovia, , Spain

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Seville, , Spain

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Vigo-Pontevedra, , Spain

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Zaragoza, , Spain

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Angered, , Sweden

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Flen, , Sweden

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Gothenburg, , Sweden

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Härnösand, , Sweden

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Höllviken, , Sweden

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Kristianstad, , Sweden

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Kungsbacka, , Sweden

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Luleå, , Sweden

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Malmo, , Sweden

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Motala, , Sweden

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Örebro, , Sweden

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Östersund, , Sweden

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Södertälje, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Trollhättan, , Sweden

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Soham, Cambridgeshire, United Kingdom

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Llanelli, Carmarthenshire, United Kingdom

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Bollington, Cheshire, United Kingdom

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Macclesfield, Cheshire, United Kingdom

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Sandbach, Cheshire, United Kingdom

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Rhyl, Denbighshire, United Kingdom

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Waterlooville, Hampshire, United Kingdom

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Wishaw, Lanarkshire, United Kingdom

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Corby, Northamptonshire, United Kingdom

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Wellingborough, Northamptonshire, United Kingdom

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Leiston, Suffolk, United Kingdom

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Bexhill-on-Sea, Sussex East, United Kingdom

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Gateshead, Tyne & Wear, United Kingdom

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Bebington, , United Kingdom

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Buckley, , United Kingdom

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Cardiff, , United Kingdom

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Cardiff, , United Kingdom

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Colchester, , United Kingdom

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Corbridge, , United Kingdom

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Cornwall, , United Kingdom

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Edinburgh, , United Kingdom

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Hull, , United Kingdom

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Irlam, Manchester, , United Kingdom

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Larbet, , United Kingdom

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Manchester, , United Kingdom

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Newport, , United Kingdom

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Newport, Isle of Wight, , United Kingdom

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Poole, , United Kingdom

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Southampton, , United Kingdom

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Swinton, , United Kingdom

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Warrington, , United Kingdom

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Countries

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Germany Netherlands Spain Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 31720293 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-004369-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

206854

Identifier Type: -

Identifier Source: org_study_id

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