Pulmonary Disease, Chronic ObstructivePhase 4NCT03467425
INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
A Phase 4 study testing FF/UMEC/VI, Inhaled Corticosteroid and LAMA in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 143 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- FF/UMEC/VI, Inhaled Corticosteroid and LAMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,109 participants
- Where
- 143 sitesin 5 countries
- Study dates
- 11 Apr 2018to 10 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
143 sites in 5 countries.
143 sites in 5 countries
Germany54 sites
GSK Investigational Site
Aschaffenburg, Bavaria, 63739
GSK Investigational Site
Bergisch Gladbach, North Rhine-Westphalia, 51429
GSK Investigational Site
Berlin, 10119
GSK Investigational Site
Berlin, 10367
GSK Investigational Site
Berlin, 10625
GSK Investigational Site
Berlin, 10717
GSK Investigational Site
Berlin, 10969
GSK Investigational Site
Berlin, 12159
GSK Investigational Site
Berlin, 12203
GSK Investigational Site
Berlin, 13086
GSK Investigational Site
Berlin, 13156
GSK Investigational Site
Berlin, 13187
GSK Investigational Site
Berlin, 14059
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53119
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069
GSK Investigational Site
Cottbus, Brandenburg, 03050
GSK Investigational Site
Dachau, Bavaria, 85221
GSK Investigational Site
Darmstadt, Hesse, 64283
GSK Investigational Site
Deggendorf, 94469
GSK Investigational Site
Delitzsch, Saxony, 04509
GSK Investigational Site
Essen, North Rhine-Westphalia, 45355
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Frankfurt am Main, Hesse, 60389
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Fulda, Hesse, 36039
GSK Investigational Site
Fürstenwalde, Brandenburg, 15517
GSK Investigational Site
Garmisch-Partenirchen, Bavaria, 82467
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502
GSK Investigational Site
Gelsenkirchen, North Rhine-Westphalia, 45879
GSK Investigational Site
Halle, Saxony-Anhalt, 06108
GSK Investigational Site
Hamburg, 22299
GSK Investigational Site
Hanover, Lower Saxony, 30167
GSK Investigational Site
Hanover, Lower Saxony, 30173
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Leipzig, Saxony, 04157
GSK Investigational Site
Leipzig, Saxony, 04207
GSK Investigational Site
Leipzig, Saxony, 04275
GSK Investigational Site
Leipzig, Saxony, 04357
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23558
GSK Investigational Site
Marburg, Hesse, 35037
GSK Investigational Site
Peine, Lower Saxony, 31224
GSK Investigational Site
Potsdam, Brandenburg, 14467
GSK Investigational Site
Potsdam, Brandenburg, 14469
GSK Investigational Site
Rheine, North Rhine-Westphalia, 48431
GSK Investigational Site
Rodgau, Hesse, 63110
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562
GSK Investigational Site
Rüsselsheim am Main, Hesse, 65428
GSK Investigational Site
Schleswig, Schleswig-Holstein, 24837
GSK Investigational Site
Schmölln, Thuringia, 04626
GSK Investigational Site
Teuchern, Saxony-Anhalt, 06682
GSK Investigational Site
Wallerfing, Bavaria, 94574
GSK Investigational Site
Wardenburg, Lower Saxony, 26203
GSK Investigational Site
Warendorf, North Rhine-Westphalia, 48231
United Kingdom31 sites
GSK Investigational Site
Bebington, CH63 9JP
GSK Investigational Site
Bexhill-on-Sea, Sussex East, TN40 1JJ
GSK Investigational Site
Bollington, Cheshire, SK10 5JH
GSK Investigational Site
Buckley, CH7 3HB
GSK Investigational Site
Cardiff, CF23 9PN
GSK Investigational Site
Cardiff, CF3 3LG
GSK Investigational Site
Colchester, CO2 7GH
GSK Investigational Site
Corbridge, NE45 5LG
GSK Investigational Site
Corby, Northamptonshire, NN17 2UR
GSK Investigational Site
Cornwall, TR27 5DT
GSK Investigational Site
Edinburgh, EH16 4SA
GSK Investigational Site
Gateshead, Tyne & Wear, NE8 2PQ
GSK Investigational Site
Hull, HU12 8JD
GSK Investigational Site
Irlam, Manchester, M44 5LH
GSK Investigational Site
Larbet, FK5 4WR
GSK Investigational Site
Leiston, Suffolk, IP16 4ES
GSK Investigational Site
Llanelli, Carmarthenshire, SA14 8QF
GSK Investigational Site
Macclesfield, Cheshire, SK11 6JL
GSK Investigational Site
Manchester, M28 1PB
GSK Investigational Site
Newport, NP20 4SZ
GSK Investigational Site
Newport, Isle of Wight, PO30 5TG
GSK Investigational Site
Poole, BH15 2HX
GSK Investigational Site
Rhyl, Denbighshire, LL18 1DA
GSK Investigational Site
Sandbach, Cheshire, CW11 1EQ
GSK Investigational Site
Soham, Cambridgeshire, CB7 5JD
GSK Investigational Site
Southampton, SO16 6YD
GSK Investigational Site
Swinton, M27 4AF
GSK Investigational Site
Warrington, WA2 7NJ
GSK Investigational Site
Waterlooville, Hampshire, PO8 8DL
GSK Investigational Site
Wellingborough, Northamptonshire, NN8 4RW
GSK Investigational Site
Wishaw, Lanarkshire, ML2 0DP
Spain24 sites
GSK Investigational Site
Alcorcón (Madrid), 28922
GSK Investigational Site
Alzira/Valencia, 46600
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08023
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Basurto/Bilbao, 48013
GSK Investigational Site
Benalmádena, Málaga, 29630
GSK Investigational Site
Cáceres, 10003
GSK Investigational Site
Cadiz, 10009
GSK Investigational Site
L'Hospitalet de Llobregat. Barcelona, 08907
GSK Investigational Site
La Roca Del Valles (Barcelona), 08430
GSK Investigational Site
Laredo, Cantabria, 39770
GSK Investigational Site
Logroño, 26006
GSK Investigational Site
Loja/ Granada, 18300
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Marbella - Málaga, Andalusia, 29603
GSK Investigational Site
Palma de Mallorca, 07010
GSK Investigational Site
Ponferrada (León), 24404
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223
GSK Investigational Site
Segovia, 40002
GSK Investigational Site
Seville, 41009
GSK Investigational Site
Torrejón de Ardoz, Madrid, 28850
GSK Investigational Site
Vigo-Pontevedra, 36312
GSK Investigational Site
Zaragoza, 50009
Sweden18 sites
GSK Investigational Site
Angered, SE-424 22
GSK Investigational Site
Flen, SE-642 37
GSK Investigational Site
Gothenburg, SE-413 90
GSK Investigational Site
Gothenburg, SE-417 17
GSK Investigational Site
Gothenburg, SE-418 73
GSK Investigational Site
Härnösand, SE-871 82
GSK Investigational Site
Höllviken, SE-236 51
GSK Investigational Site
Kristianstad, SE-291 85
GSK Investigational Site
Kungsbacka, SE-434 80
GSK Investigational Site
Luleå, SE-971 89
GSK Investigational Site
Malmö, SE-205 02
GSK Investigational Site
Motala, SE- 591 85
GSK Investigational Site
Örebro, SE-703 62
GSK Investigational Site
Östersund, SE-831 83
GSK Investigational Site
Södertälje, SE-152 86
GSK Investigational Site
Stockholm, 11446
GSK Investigational Site
Stockholm, SE-113 61
GSK Investigational Site
Trollhättan, SE-461 73
Netherlands16 sites
GSK Investigational Site
Alkmaar, 1815 JD
GSK Investigational Site
Breda, 4818 CK
GSK Investigational Site
Dordrecht, 3318 AT
GSK Investigational Site
Groningen, 9718 AW
GSK Investigational Site
Groningen, 9728 NT
GSK Investigational Site
Harderwijk, 3844 DG
GSK Investigational Site
Heerlen, 6419 PC
GSK Investigational Site
Hengelo, 7555 DL
GSK Investigational Site
Hoorn, 1624 NP
GSK Investigational Site
Kloosterhaar, 7694 AC
GSK Investigational Site
Nijmegen, 6532 SZ
GSK Investigational Site
Rotterdam, 3045 PM
GSK Investigational Site
Rotterdam, 3051 GV
GSK Investigational Site
Rotterdam, 3083 AN
GSK Investigational Site
Zeist, 3703 CD
GSK Investigational Site
Zutphen, 7207 AE
About this study
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
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
- Being tested
- FF/UMEC/VI, Inhaled Corticosteroid, LAMA, LABA, COPD rescue medications
- Keywords
- FF/VI/UMEC, TRELEGY ELLIPTA, COPD, Effectiveness
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FF/UMEC/VIDrug
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.
Inhaled CorticosteroidDrug
Inhaled Corticosteroid (ICS) as prescribed by the physician.
LAMADrug
LAMA as prescribed by the physician.
LABADrug
LABA as prescribed by the physician.
COPD rescue medicationsDrug
Rescue medications for COPD will be prescribed and obtained according to usual practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Inhaled Corticosteroid; Drug: LAMA; Drug: LABA; Drug: COPD rescue medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 24
Secondary outcomes (2)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were collected using a spirometer. Baseline was defined as the value recorded at Day 1. Change from Baseline was calculated as FEV1 value at Week 24 minus the Baseline value. A treatment policy strategy was used for the intercurrent events of randomized treatment discontinuation, randomized treatment modification, change of pulmonary rehabilitation status and start of oxygen therapy. Only those participants with non-missing covariates were included in the analysis.
Measured: Baseline (Day 1) and at Week 24
Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24
Participants were trained on the correct use of their inhaler devices. All participants who had spirometry measured were to have an assessment of inhaler errors. During the assessment, participants were asked to demonstrate inhaler use when taking their regular dose of medication. A critical error is defined as an error that is most likely to result in no or significantly reduced medication being inhaled. These errors were recorded in an error checklist, during the assessment. A hypothetical strategy was used for the intercurrent event of randomized treatment modification. Percentage of participants making at least 1 critical error in inhalation technique at the Week 24 is presented.
Measured: At Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start11 Apr 2018
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 3,109 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467425
- Sponsor's protocol ID
- 206854
- Other IDs
- 2017-004369-29, 2017
- Status last verified
- Jul 2020
- First submitted
- 2 Feb 2018
- Last updated
- 7 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Beeh KM, Claussen J, Shah D, Martin A, Kendall R, Dasari P, Ismaila AS, Noorduyn SG. Cost-Effectiveness of Single-Inhaler Versus Multiple-Inhaler Triple Therapy in COPD: A German Healthcare Perspective. Int J Chron Obstruct Pulmon Dis. 2025 Jun 19;20:2011-2022. doi: 10.2147/COPD.S492524. eCollection 2025.
PubMed 40551758Worsley 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.
PubMed 31720293
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03467425
- Acronym / sponsor ID
- 206854
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- FF/VI/UMEC, TRELEGY ELLIPTA, COPD, Effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,109 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Posted 7 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TRELEGY ELLIPTA (FF/UMEC/VI: 100 mcg/62.5 mcg/25 mcg) | Experimental | Drug: FF/UMEC/VI, Drug: COPD rescue medicationsEligible 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. |
| Non-ELLIPTA MITT | Active comparator | Drug: Inhaled Corticosteroid, Drug: LAMA, Drug: LABA, Drug: COPD rescue medicationsEligible 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FF/UMEC/VIFF 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 | TRELEGY ELLIPTA (FF/UMEC/VI: 100 mcg/62.5 mcg/25 mcg) |
| Inhaled CorticosteroidInhaled Corticosteroid (ICS) as prescribed by the physician. | Drug | Non-ELLIPTA MITT |
| LAMALAMA as prescribed by the physician. | Drug | Non-ELLIPTA MITT |
| LABALABA as prescribed by the physician. | Drug | Non-ELLIPTA MITT |
| COPD rescue medicationsRescue medications for COPD will be prescribed and obtained according to usual practice. | Drug | Non-ELLIPTA MITT, TRELEGY ELLIPTA (FF/UMEC/VI: 100 mcg/62.5 mcg/25 mcg) |
Primary outcome
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
Time frame: 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.
2 secondary outcomes
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24
Time frame: Baseline (Day 1) and at Week 24
Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24
Time frame: At Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40551758Beeh KM, Claussen J, Shah D, Martin A, Kendall R, Dasari P, Ismaila AS, Noorduyn SG. Cost-Effectiveness of Single-Inhaler Versus Multiple-Inhaler Triple Therapy in COPD: A German Healthcare Perspective. Int J Chron Obstruct Pulmon Dis. 2025 Jun 19;20:2011-2022. doi: 10.2147/COPD.S492524. eCollection 2025.
- Derived from this study: PubMed 31720293Worsley 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.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
143 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FF/UMEC/VI, Inhaled Corticosteroid and LAMA in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 143 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 143 sites in Germany, United Kingdom, Spain, Sweden, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03467425, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.