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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Germany

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

Other trials in United Kingdom

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

Other trials in Spain

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

Other trials in Sweden

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

Other trials in Netherlands

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.

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 groups in NCT03467425
Study groupRoleWhat they receive
TRELEGY ELLIPTA (FF/UMEC/VI: 100 mcg/62.5 mcg/25 mcg)ExperimentalEligible 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 MITTActive comparatorEligible 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.

  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.

    Measured: At Week 24

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted16 Mar 2018
  2. Study start11 Apr 2018
  3. Primary completion10 Oct 2019
  4. Study completion10 Oct 2019

Resources

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)
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
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 40551758
  • 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.

    PubMed 31720293

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.

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