INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design

NCT03467425 | Completed Phase 4 Results

• 2 other identifiers: 2068542017-004369-29
• Study Type: interventional
• Target: 3,109
• Locations: 5 countries
• Sites: 143

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

FF/VI/UMEC; TRELEGY ELLIPTA; COPD; Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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

  The CAT is a 8-item questionnaire, used to measure the health status of par. with COPD. Par. rated their experience on a 6-point scale: 0 (no impact) to 5 (maximum impact). CAT score was calculated by summing the non-missing scores of the 8 items with a range of 0-40. Higher scores indicate greater disease impact. Responders were par. who had a change from Baseline score \>=2 at Week 24. Non-responders were the par. who had change from Baseline score \<2 at Week 24. Change from Baseline was calculated as Week 24 value minus the Baseline value (Day 1). A composite strategy was applied when intercurrent events of randomized treatment modification, change in pulmonary rehabilitation or start of oxygen therapy occurred, otherwise a treatment policy strategy was applied. Missing Week 24 CAT data were imputed assuming missing at random and are presented in a separate category. Number of responders, non-responders based on CAT and par. with imputed CAT score at Week 24 are presented.

  At Week 24

Secondary Outcomes (2)

• Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24

  Baseline (Day 1) and at Week 24

• Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24

  At Week 24

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: FF/UMEC/VI; Drug: COPD rescue medications

Non-ELLIPTA MITT

ACTIVE COMPARATOR

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.

Drug: Inhaled Corticosteroid; Drug: LAMA; Drug: LABA; Drug: COPD rescue medications

Interventions

FF/UMEC/VI 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.

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

Inhaled Corticosteroid DRUG

Inhaled Corticosteroid (ICS) as prescribed by the physician.

Non-ELLIPTA MITT

LAMA DRUG

LAMA as prescribed by the physician.

Non-ELLIPTA MITT

LABA DRUG

LABA as prescribed by the physician.

Non-ELLIPTA MITT

COPD rescue medications DRUG

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

Non-ELLIPTA MITT; TRELEGY ELLIPTA (FF/UMEC/VI: 100 mcg/62.5 mcg/25 mcg)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (143)

GSK Investigational Site

Aschaffenburg, Bavaria, 63739, Germany

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GSK Investigational Site

Dachau, Bavaria, 85221, Germany

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Garmisch-Partenirchen, Bavaria, 82467, Germany

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Wallerfing, Bavaria, 94574, Germany

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Cottbus, Brandenburg, 03050, Germany

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Fürstenwalde, Brandenburg, 15517, Germany

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Potsdam, Brandenburg, 14467, Germany

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Potsdam, Brandenburg, 14469, Germany

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Rüdersdorf, Brandenburg, 15562, Germany

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Darmstadt, Hesse, 64283, Germany

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Frankfurt am Main, Hesse, 60389, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Fulda, Hesse, 36039, Germany

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Marburg, Hesse, 35037, Germany

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Rodgau, Hesse, 63110, Germany

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Rüsselsheim am Main, Hesse, 65428, Germany

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Hanover, Lower Saxony, 30167, Germany

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Hanover, Lower Saxony, 30173, Germany

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Peine, Lower Saxony, 31224, Germany

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Wardenburg, Lower Saxony, 26203, Germany

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Bergisch Gladbach, North Rhine-Westphalia, 51429, Germany

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Bonn, North Rhine-Westphalia, 53119, Germany

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Cologne, North Rhine-Westphalia, 51069, Germany

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Essen, North Rhine-Westphalia, 45355, Germany

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Essen, North Rhine-Westphalia, 45359, Germany

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Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

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Rheine, North Rhine-Westphalia, 48431, Germany

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Warendorf, North Rhine-Westphalia, 48231, Germany

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Koblenz, Rhineland-Palatinate, 56068, Germany

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Delitzsch, Saxony, 04509, Germany

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Leipzig, Saxony, 04103, Germany

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Leipzig, Saxony, 04157, Germany

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Leipzig, Saxony, 04207, Germany

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Leipzig, Saxony, 04275, Germany

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Leipzig, Saxony, 04357, Germany

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Halle, Saxony-Anhalt, 06108, Germany

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Teuchern, Saxony-Anhalt, 06682, Germany

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Geesthacht, Schleswig-Holstein, 21502, Germany

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Lübeck, Schleswig-Holstein, 23558, Germany

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Schleswig, Schleswig-Holstein, 24837, Germany

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Schmölln, Thuringia, 04626, Germany

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Berlin, 10119, Germany

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Berlin, 10367, Germany

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Berlin, 10625, Germany

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Berlin, 10717, Germany

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Berlin, 10969, Germany

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Berlin, 12159, Germany

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Berlin, 12203, Germany

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Berlin, 13086, Germany

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Berlin, 13156, Germany

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Berlin, 13187, Germany

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Berlin, 14059, Germany

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Deggendorf, 94469, Germany

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Hamburg, 22299, Germany

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Alkmaar, 1815 JD, Netherlands

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Breda, 4818 CK, Netherlands

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Dordrecht, 3318 AT, Netherlands

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Groningen, 9718 AW, Netherlands

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Groningen, 9728 NT, Netherlands

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Harderwijk, 3844 DG, Netherlands

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Heerlen, 6419 PC, Netherlands

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Hengelo, 7555 DL, Netherlands

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Hoorn, 1624 NP, Netherlands

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Kloosterhaar, 7694 AC, Netherlands

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Nijmegen, 6532 SZ, Netherlands

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Rotterdam, 3045 PM, Netherlands

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Rotterdam, 3051 GV, Netherlands

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Rotterdam, 3083 AN, Netherlands

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Zeist, 3703 CD, Netherlands

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Zutphen, 7207 AE, Netherlands

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Marbella - Málaga, Andalusia, 29603, Spain

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Laredo, Cantabria, 39770, Spain

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Torrejón de Ardoz, Madrid, 28850, Spain

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Alcorcón (Madrid), 28922, Spain

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Alzira/Valencia, 46600, Spain

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Barcelona, 08003, Spain

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Barcelona, 08023, Spain

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Barcelona, 08035, Spain

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Basurto/Bilbao, 48013, Spain

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Benalmádena, Málaga, 29630, Spain

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Cadiz, 10009, Spain

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Cáceres, 10003, Spain

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L'Hospitalet de Llobregat. Barcelona, 08907, Spain

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La Roca Del Valles (Barcelona), 08430, Spain

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Logroño, 26006, Spain

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Loja/ Granada, 18300, Spain

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Madrid, 28040, Spain

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Palma de Mallorca, 07010, Spain

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Ponferrada (León), 24404, Spain

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Pozuelo de Alarcón/Madrid, 28223, Spain

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Segovia, 40002, Spain

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Seville, 41009, Spain

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Vigo-Pontevedra, 36312, Spain

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Zaragoza, 50009, Spain

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GSK Investigational Site

Angered, SE-424 22, Sweden

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Flen, SE-642 37, Sweden

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Gothenburg, SE-413 90, Sweden

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Gothenburg, SE-417 17, Sweden

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Gothenburg, SE-418 73, Sweden

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Härnösand, SE-871 82, Sweden

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Höllviken, SE-236 51, Sweden

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Kristianstad, SE-291 85, Sweden

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Kungsbacka, SE-434 80, Sweden

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Luleå, SE-971 89, Sweden

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Malmo, SE-205 02, Sweden

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Motala, SE- 591 85, Sweden

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Örebro, SE-703 62, Sweden

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Östersund, SE-831 83, Sweden

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Södertälje, SE-152 86, Sweden

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Stockholm, 11446, Sweden

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Stockholm, SE-113 61, Sweden

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Trollhättan, SE-461 73, Sweden

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Soham, Cambridgeshire, CB7 5JD, United Kingdom

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Llanelli, Carmarthenshire, SA14 8QF, United Kingdom

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Bollington, Cheshire, SK10 5JH, United Kingdom

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Macclesfield, Cheshire, SK11 6JL, United Kingdom

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Sandbach, Cheshire, CW11 1EQ, United Kingdom

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Rhyl, Denbighshire, LL18 1DA, United Kingdom

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Waterlooville, Hampshire, PO8 8DL, United Kingdom

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Wishaw, Lanarkshire, ML2 0DP, United Kingdom

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Corby, Northamptonshire, NN17 2UR, United Kingdom

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Wellingborough, Northamptonshire, NN8 4RW, United Kingdom

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Leiston, Suffolk, IP16 4ES, United Kingdom

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Bexhill-on-Sea, Sussex East, TN40 1JJ, United Kingdom

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Gateshead, Tyne & Wear, NE8 2PQ, United Kingdom

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Bebington, CH63 9JP, United Kingdom

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Buckley, CH7 3HB, United Kingdom

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Cardiff, CF23 9PN, United Kingdom

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Cardiff, CF3 3LG, United Kingdom

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Colchester, CO2 7GH, United Kingdom

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Corbridge, NE45 5LG, United Kingdom

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Cornwall, TR27 5DT, United Kingdom

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Edinburgh, EH16 4SA, United Kingdom

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Hull, HU12 8JD, United Kingdom

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Irlam, Manchester, M44 5LH, United Kingdom

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Larbet, FK5 4WR, United Kingdom

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Manchester, M28 1PB, United Kingdom

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Newport, NP20 4SZ, United Kingdom

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Newport, Isle of Wight, PO30 5TG, United Kingdom

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Poole, BH15 2HX, United Kingdom

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Southampton, SO16 6YD, United Kingdom

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Swinton, M27 4AF, United Kingdom

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Warrington, WA2 7NJ, United Kingdom

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Related Publications (1)

• 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.

  PMID: 31720293 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: March 16, 2018
• Study Start: April 11, 2018
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: September 7, 2020
• Results First Posted: September 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

ES (24); NL (16); DE (54); SE (18); GB (31)