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INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
FF/UMEC/VI
Inhaled Corticosteroid
LAMA
LABA
COPD rescue medications
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring FF/VI/UMEC, TRELEGY ELLIPTA, COPD, Effectiveness

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • GSK Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Non-ELLIPTA MITT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 2, 2018
Last Updated
August 19, 2020
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT03467425
Brief Title
INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
Official Title
The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in a Single Inhaler (TRELEGY™ ELLIPTA™) When Compared With Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients Within a Usual Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
FF/VI/UMEC, TRELEGY ELLIPTA, COPD, Effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
3109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRELEGY ELLIPTA (FF/UMEC/VI: 100 mcg/62.5 mcg/25 mcg)
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-ELLIPTA MITT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FF/UMEC/VI
Intervention Description
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
Intervention Name(s)
Inhaled Corticosteroid
Intervention Description
Inhaled Corticosteroid (ICS) as prescribed by the physician.
Intervention Type
Drug
Intervention Name(s)
LAMA
Intervention Description
LAMA as prescribed by the physician.
Intervention Type
Drug
Intervention Name(s)
LABA
Intervention Description
LABA as prescribed by the physician.
Intervention Type
Drug
Intervention Name(s)
COPD rescue medications
Intervention Description
Rescue medications for COPD will be prescribed and obtained according to usual practice.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
At Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24
Description
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.
Time Frame
Baseline (Day 1) and at Week 24
Title
Percentage of Participants Making at Least 1 Critical Error in Inhalation Technique at Week 24
Description
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.
Time Frame
At Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Capable of giving signed informed consent. Subjects with a documented physician diagnosis of COPD. A score of >=10 on the CAT at screening. Subjects who have a history of treatment with systemic/oral corticosteroids, antibiotics and/or hospitalization for at least one COPD exacerbation in the 3 years prior to randomization. This will be captured through subject recall and/or medical records and must be documented in subject's notes. Prior use of systemic/oral corticosteroids and/or antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD. Subjects currently receiving one of the non-ELLIPTA maintenance therapies listed below who have been prescribed it continually for at least 16 weeks prior to randomization. Continuous prescription is defined as a minimum of 60 days' prescription cover during the prior 16 weeks. The non-ELLIPTA maintenance therapy must be one of the following: Inhaled Corticosteroid (ICS) in combination with Long-acting Muscarinic Receptor Antagonist (LAMA) and Long Acting Beta-Agonist (LABA) (MITT) or LAMA and LABA used in combination as a dual therapy or LABA and ICS used in combination as a dual therapy. Subjects who are currently on a dual maintenance therapy for COPD must be considered by their physician to require a step-up to triple therapy. The reason for the physician decision to step- up must be documented. Subjects who are receiving only COPD medication on an 'as required' basis are not eligible. Subjects must be aged >=40 years of age at the time of signing the informed consent. Exclusion Criteria: Women of child bearing potential: Women who are pregnant or lactating or are planning on becoming pregnant during the study. Subjects with any life-threatening condition i.e. low probability, in the opinion of the investigator, of 6-month survival due to severity of COPD or comorbid condition. Subjects with resolution of an exacerbation less than 2 weeks prior to visit 1, must not be randomized. Subjects may be rescreened 2 weeks after resolution of exacerbation (exacerbation is defined by treatment with systemic corticosteroids and/or antibiotic). Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the effectiveness or safety analysis if the disease/condition exacerbated during the study. A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator contraindicates study participation. Subjects who, in the opinion of the treating investigator, are chronic users of oral corticosteroids for respiratory or other indications (if unsure discuss with the medical monitor prior to screening). Chronic use is defined as more than 14 days continuous use during the 12 weeks prior to visit 1. Subjects taking any investigational drug treatment within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study (whichever is the longer of the two).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Aschaffenburg
State/Province
Bayern
ZIP/Postal Code
63739
Country
Germany
Facility Name
GSK Investigational Site
City
Dachau
State/Province
Bayern
ZIP/Postal Code
85221
Country
Germany
Facility Name
GSK Investigational Site
City
Garmisch-Partenirchen
State/Province
Bayern
ZIP/Postal Code
82467
Country
Germany
Facility Name
GSK Investigational Site
City
Wallerfing
State/Province
Bayern
ZIP/Postal Code
94574
Country
Germany
Facility Name
GSK Investigational Site
City
Cottbus
State/Province
Brandenburg
ZIP/Postal Code
03050
Country
Germany
Facility Name
GSK Investigational Site
City
Fuerstenwalde
State/Province
Brandenburg
ZIP/Postal Code
15517
Country
Germany
Facility Name
GSK Investigational Site
City
Potsdam
State/Province
Brandenburg
ZIP/Postal Code
14467
Country
Germany
Facility Name
GSK Investigational Site
City
Potsdam
State/Province
Brandenburg
ZIP/Postal Code
14469
Country
Germany
Facility Name
GSK Investigational Site
City
Ruedersdorf
State/Province
Brandenburg
ZIP/Postal Code
15562
Country
Germany
Facility Name
GSK Investigational Site
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64283
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60389
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
GSK Investigational Site
City
Fulda
State/Province
Hessen
ZIP/Postal Code
36039
Country
Germany
Facility Name
GSK Investigational Site
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35037
Country
Germany
Facility Name
GSK Investigational Site
City
Rodgau
State/Province
Hessen
ZIP/Postal Code
63110
Country
Germany
Facility Name
GSK Investigational Site
City
Ruesselsheim
State/Province
Hessen
ZIP/Postal Code
65428
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30167
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30173
Country
Germany
Facility Name
GSK Investigational Site
City
Peine
State/Province
Niedersachsen
ZIP/Postal Code
31224
Country
Germany
Facility Name
GSK Investigational Site
City
Wardenburg
State/Province
Niedersachsen
ZIP/Postal Code
26203
Country
Germany
Facility Name
GSK Investigational Site
City
Bergisch Gladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51429
Country
Germany
Facility Name
GSK Investigational Site
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53119
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45355
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45359
Country
Germany
Facility Name
GSK Investigational Site
City
Gelsenkirchen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45879
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51069
Country
Germany
Facility Name
GSK Investigational Site
City
Rheine
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48431
Country
Germany
Facility Name
GSK Investigational Site
City
Warendorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48231
Country
Germany
Facility Name
GSK Investigational Site
City
Koblenz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
56068
Country
Germany
Facility Name
GSK Investigational Site
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06108
Country
Germany
Facility Name
GSK Investigational Site
City
Teuchern
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06682
Country
Germany
Facility Name
GSK Investigational Site
City
Delitzsch
State/Province
Sachsen
ZIP/Postal Code
04509
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04157
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04207
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04275
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04357
Country
Germany
Facility Name
GSK Investigational Site
City
Geesthacht
State/Province
Schleswig-Holstein
ZIP/Postal Code
21502
Country
Germany
Facility Name
GSK Investigational Site
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23558
Country
Germany
Facility Name
GSK Investigational Site
City
Schleswig
State/Province
Schleswig-Holstein
ZIP/Postal Code
24837
Country
Germany
Facility Name
GSK Investigational Site
City
Schmoelln
State/Province
Thueringen
ZIP/Postal Code
04626
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10119
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10625
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10717
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12159
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13086
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13156
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13187
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
GSK Investigational Site
City
Deggendorf
ZIP/Postal Code
94469
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22299
Country
Germany
Facility Name
GSK Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
GSK Investigational Site
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
GSK Investigational Site
City
Groningen
ZIP/Postal Code
9718 AW
Country
Netherlands
Facility Name
GSK Investigational Site
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
GSK Investigational Site
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
GSK Investigational Site
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
GSK Investigational Site
City
Hengelo
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
GSK Investigational Site
City
Hoorn
ZIP/Postal Code
1624 NP
Country
Netherlands
Facility Name
GSK Investigational Site
City
Kloosterhaar
ZIP/Postal Code
7694 AC
Country
Netherlands
Facility Name
GSK Investigational Site
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3051 GV
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
GSK Investigational Site
City
Zeist
ZIP/Postal Code
3703 CD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Zutphen
ZIP/Postal Code
7207 AE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Marbella - Málaga
State/Province
Andalucia
ZIP/Postal Code
29603
Country
Spain
Facility Name
GSK Investigational Site
City
Laredo
State/Province
Cantabria
ZIP/Postal Code
39770
Country
Spain
Facility Name
GSK Investigational Site
City
Torrejón de Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Facility Name
GSK Investigational Site
City
Alcorcón (Madrid)
ZIP/Postal Code
28922
Country
Spain
Facility Name
GSK Investigational Site
City
Alzira/Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Basurto/Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
GSK Investigational Site
City
Benalmádena, Málaga
ZIP/Postal Code
29630
Country
Spain
Facility Name
GSK Investigational Site
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
GSK Investigational Site
City
Cádiz
ZIP/Postal Code
10009
Country
Spain
Facility Name
GSK Investigational Site
City
L'Hospitalet De Llobregat. Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
GSK Investigational Site
City
La Roca Del Valles (Barcelona)
ZIP/Postal Code
08430
Country
Spain
Facility Name
GSK Investigational Site
City
Logroño
ZIP/Postal Code
26006
Country
Spain
Facility Name
GSK Investigational Site
City
Loja/ Granada
ZIP/Postal Code
18300
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07010
Country
Spain
Facility Name
GSK Investigational Site
City
Ponferrada (León)
ZIP/Postal Code
24404
Country
Spain
Facility Name
GSK Investigational Site
City
Pozuelo De Alarcón/Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
GSK Investigational Site
City
Segovia
ZIP/Postal Code
40002
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
GSK Investigational Site
City
Vigo-Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
GSK Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
GSK Investigational Site
City
Angered
ZIP/Postal Code
SE-424 22
Country
Sweden
Facility Name
GSK Investigational Site
City
Flen
ZIP/Postal Code
SE-642 37
Country
Sweden
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-413 90
Country
Sweden
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-417 17
Country
Sweden
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-418 73
Country
Sweden
Facility Name
GSK Investigational Site
City
Härnösand
ZIP/Postal Code
SE-871 82
Country
Sweden
Facility Name
GSK Investigational Site
City
Höllviken
ZIP/Postal Code
SE-236 51
Country
Sweden
Facility Name
GSK Investigational Site
City
Kristianstad
ZIP/Postal Code
SE-291 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Kungsbacka
ZIP/Postal Code
SE-434 80
Country
Sweden
Facility Name
GSK Investigational Site
City
Luleå
ZIP/Postal Code
SE-971 89
Country
Sweden
Facility Name
GSK Investigational Site
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
GSK Investigational Site
City
Motala
ZIP/Postal Code
SE- 591 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Stockholm
ZIP/Postal Code
11446
Country
Sweden
Facility Name
GSK Investigational Site
City
Stockholm
ZIP/Postal Code
SE-113 61
Country
Sweden
Facility Name
GSK Investigational Site
City
Södertälje
ZIP/Postal Code
SE-152 86
Country
Sweden
Facility Name
GSK Investigational Site
City
Trollhättan
ZIP/Postal Code
SE-461 73
Country
Sweden
Facility Name
GSK Investigational Site
City
Örebro
ZIP/Postal Code
SE-703 62
Country
Sweden
Facility Name
GSK Investigational Site
City
Östersund
ZIP/Postal Code
SE-831 83
Country
Sweden
Facility Name
GSK Investigational Site
City
Soham
State/Province
Cambridgeshire
ZIP/Postal Code
CB7 5JD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Llanelli
State/Province
Carmarthenshire
ZIP/Postal Code
SA14 8QF
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bollington
State/Province
Cheshire
ZIP/Postal Code
SK10 5JH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Macclesfield
State/Province
Cheshire
ZIP/Postal Code
SK11 6JL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Sandbach
State/Province
Cheshire
ZIP/Postal Code
CW11 1EQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Rhyl
State/Province
Denbighshire
ZIP/Postal Code
LL18 1DA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Waterlooville
State/Province
Hampshire
ZIP/Postal Code
PO8 8DL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Wishaw
State/Province
Lanarkshire
ZIP/Postal Code
ML2 0DP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Corby
State/Province
Northamptonshire
ZIP/Postal Code
NN17 2UR
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Wellingborough
State/Province
Northamptonshire
ZIP/Postal Code
NN8 4RW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Leiston
State/Province
Suffolk
ZIP/Postal Code
IP16 4ES
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bexhill
State/Province
Sussex East
ZIP/Postal Code
TN40 1JJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Gateshead
State/Province
Tyne & Wear
ZIP/Postal Code
NE8 2PQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bebington
ZIP/Postal Code
CH63 9JP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Buckley
ZIP/Postal Code
CH7 3HB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Cardiff
ZIP/Postal Code
CF23 9PN
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Cardiff
ZIP/Postal Code
CF3 3LG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Colchester
ZIP/Postal Code
CO2 7GH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Corbridge
ZIP/Postal Code
NE45 5LG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Cornwall
ZIP/Postal Code
TR27 5DT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Hull
ZIP/Postal Code
HU12 8JD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Irlam, Manchester
ZIP/Postal Code
M44 5LH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Larbet
ZIP/Postal Code
FK5 4WR
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M28 1PB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Newport, Isle Of Wight
ZIP/Postal Code
PO30 5TG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Newport
ZIP/Postal Code
NP20 4SZ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Poole
ZIP/Postal Code
BH15 2HX
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Swinton
ZIP/Postal Code
M27 4AF
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Warrington
ZIP/Postal Code
WA2 7NJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
IPD Sharing 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.
IPD Sharing URL
http://clinicalstudydatarequest.com
Citations:
PubMed Identifier
31720293
Citation
Worsley S, Snowise N, Halpin DMG, Midwinter D, Ismaila AS, Irving E, Sansbury L, Tabberer M, Leather D, Compton C. Clinical effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol in usual practice: the COPD INTREPID study design. ERJ Open Res. 2019 Nov 4;5(4):00061-2019. doi: 10.1183/23120541.00061-2019. eCollection 2019 Oct.
Results Reference
derived

Learn more about this trial

INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design

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