INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design

August 19, 2020 updated by: GlaxoSmithKline

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10367
        • GSK Investigational Site
      • Berlin, Germany, 14059
        • GSK Investigational Site
      • Berlin, Germany, 13086
        • GSK Investigational Site
      • Berlin, Germany, 10717
        • GSK Investigational Site
      • Berlin, Germany, 13187
        • GSK Investigational Site
      • Berlin, Germany, 10119
        • GSK Investigational Site
      • Berlin, Germany, 10969
        • GSK Investigational Site
      • Berlin, Germany, 12203
        • GSK Investigational Site
      • Berlin, Germany, 10625
        • GSK Investigational Site
      • Berlin, Germany, 12159
        • GSK Investigational Site
      • Berlin, Germany, 13156
        • GSK Investigational Site
      • Deggendorf, Germany, 94469
        • GSK Investigational Site
      • Hamburg, Germany, 22299
        • GSK Investigational Site
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
        • GSK Investigational Site
      • Dachau, Bayern, Germany, 85221
        • GSK Investigational Site
      • Garmisch-Partenirchen, Bayern, Germany, 82467
        • GSK Investigational Site
      • Wallerfing, Bayern, Germany, 94574
        • GSK Investigational Site
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03050
        • GSK Investigational Site
      • Fuerstenwalde, Brandenburg, Germany, 15517
        • GSK Investigational Site
      • Potsdam, Brandenburg, Germany, 14469
        • GSK Investigational Site
      • Potsdam, Brandenburg, Germany, 14467
        • GSK Investigational Site
      • Ruedersdorf, Brandenburg, Germany, 15562
        • GSK Investigational Site
    • Hessen
      • Darmstadt, Hessen, Germany, 64283
        • GSK Investigational Site
      • Frankfurt, Hessen, Germany, 60596
        • GSK Investigational Site
      • Frankfurt, Hessen, Germany, 60389
        • GSK Investigational Site
      • Fulda, Hessen, Germany, 36039
        • GSK Investigational Site
      • Marburg, Hessen, Germany, 35037
        • GSK Investigational Site
      • Rodgau, Hessen, Germany, 63110
        • GSK Investigational Site
      • Ruesselsheim, Hessen, Germany, 65428
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30173
        • GSK Investigational Site
      • Hannover, Niedersachsen, Germany, 30167
        • GSK Investigational Site
      • Peine, Niedersachsen, Germany, 31224
        • GSK Investigational Site
      • Wardenburg, Niedersachsen, Germany, 26203
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bergisch Gladbach, Nordrhein-Westfalen, Germany, 51429
        • GSK Investigational Site
      • Bonn, Nordrhein-Westfalen, Germany, 53119
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45355
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45359
        • GSK Investigational Site
      • Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51069
        • GSK Investigational Site
      • Rheine, Nordrhein-Westfalen, Germany, 48431
        • GSK Investigational Site
      • Warendorf, Nordrhein-Westfalen, Germany, 48231
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56068
        • GSK Investigational Site
    • Sachsen
      • Delitzsch, Sachsen, Germany, 04509
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04275
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04357
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04103
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04157
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04207
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06108
        • GSK Investigational Site
      • Teuchern, Sachsen-Anhalt, Germany, 06682
        • GSK Investigational Site
    • Schleswig-Holstein
      • Geesthacht, Schleswig-Holstein, Germany, 21502
        • GSK Investigational Site
      • Luebeck, Schleswig-Holstein, Germany, 23558
        • GSK Investigational Site
      • Schleswig, Schleswig-Holstein, Germany, 24837
        • GSK Investigational Site
    • Thueringen
      • Schmoelln, Thueringen, Germany, 04626
        • GSK Investigational Site
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • GSK Investigational Site
      • Breda, Netherlands, 4818 CK
        • GSK Investigational Site
      • Dordrecht, Netherlands, 3318 AT
        • GSK Investigational Site
      • Groningen, Netherlands, 9728 NT
        • GSK Investigational Site
      • Groningen, Netherlands, 9718 AW
        • GSK Investigational Site
      • Harderwijk, Netherlands, 3844 DG
        • GSK Investigational Site
      • Heerlen, Netherlands, 6419 PC
        • GSK Investigational Site
      • Hengelo, Netherlands, 7555 DL
        • GSK Investigational Site
      • Hoorn, Netherlands, 1624 NP
        • GSK Investigational Site
      • Kloosterhaar, Netherlands, 7694 AC
        • GSK Investigational Site
      • Nijmegen, Netherlands, 6532 SZ
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3083 AN
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3045 PM
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3051 GV
        • GSK Investigational Site
      • Zeist, Netherlands, 3703 CD
        • GSK Investigational Site
      • Zutphen, Netherlands, 7207 AE
        • GSK Investigational Site
  • Spain
      • Alcorcón (Madrid), Spain, 28922
        • GSK Investigational Site
      • Alzira/Valencia, Spain, 46600
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Barcelona, Spain, 08003
        • GSK Investigational Site
      • Barcelona, Spain, 08023
        • GSK Investigational Site
      • Basurto/Bilbao, Spain, 48013
        • GSK Investigational Site
      • Benalmádena, Málaga, Spain, 29630
        • GSK Investigational Site
      • Caceres, Spain, 10003
        • GSK Investigational Site
      • Cádiz, Spain, 10009
        • GSK Investigational Site
      • L'Hospitalet De Llobregat. Barcelona, Spain, 08907
        • GSK Investigational Site
      • La Roca Del Valles (Barcelona), Spain, 08430
        • GSK Investigational Site
      • Logroño, Spain, 26006
        • GSK Investigational Site
      • Loja/ Granada, Spain, 18300
        • GSK Investigational Site
      • Madrid, Spain, 28040
        • GSK Investigational Site
      • Palma de Mallorca, Spain, 07010
        • GSK Investigational Site
      • Ponferrada (León), Spain, 24404
        • GSK Investigational Site
      • Pozuelo De Alarcón/Madrid, Spain, 28223
        • GSK Investigational Site
      • Segovia, Spain, 40002
        • GSK Investigational Site
      • Sevilla, Spain, 41009
        • GSK Investigational Site
      • Vigo-Pontevedra, Spain, 36312
        • GSK Investigational Site
      • Zaragoza, Spain, 50009
        • GSK Investigational Site
    • Andalucia
      • Marbella - Málaga, Andalucia, Spain, 29603
        • GSK Investigational Site
    • Cantabria
      • Laredo, Cantabria, Spain, 39770
        • GSK Investigational Site
    • Madrid
      • Torrejón de Ardoz, Madrid, Spain, 28850
        • GSK Investigational Site
  • Sweden
      • Angered, Sweden, SE-424 22
        • GSK Investigational Site
      • Flen, Sweden, SE-642 37
        • GSK Investigational Site
      • Göteborg, Sweden, SE-413 90
        • GSK Investigational Site
      • Göteborg, Sweden, SE-417 17
        • GSK Investigational Site
      • Göteborg, Sweden, SE-418 73
        • GSK Investigational Site
      • Härnösand, Sweden, SE-871 82
        • GSK Investigational Site
      • Höllviken, Sweden, SE-236 51
        • GSK Investigational Site
      • Kristianstad, Sweden, SE-291 85
        • GSK Investigational Site
      • Kungsbacka, Sweden, SE-434 80
        • GSK Investigational Site
      • Luleå, Sweden, SE-971 89
        • GSK Investigational Site
      • Malmö, Sweden, SE-205 02
        • GSK Investigational Site
      • Motala, Sweden, SE- 591 85
        • GSK Investigational Site
      • Stockholm, Sweden, 11446
        • GSK Investigational Site
      • Stockholm, Sweden, SE-113 61
        • GSK Investigational Site
      • Södertälje, Sweden, SE-152 86
        • GSK Investigational Site
      • Trollhättan, Sweden, SE-461 73
        • GSK Investigational Site
      • Örebro, Sweden, SE-703 62
        • GSK Investigational Site
      • Östersund, Sweden, SE-831 83
        • GSK Investigational Site
  • United Kingdom
      • Bebington, United Kingdom, CH63 9JP
        • GSK Investigational Site
      • Buckley, United Kingdom, CH7 3HB
        • GSK Investigational Site
      • Cardiff, United Kingdom, CF23 9PN
        • GSK Investigational Site
      • Cardiff, United Kingdom, CF3 3LG
        • GSK Investigational Site
      • Colchester, United Kingdom, CO2 7GH
        • GSK Investigational Site
      • Corbridge, United Kingdom, NE45 5LG
        • GSK Investigational Site
      • Cornwall, United Kingdom, TR27 5DT
        • GSK Investigational Site
      • Edinburgh, United Kingdom, EH16 4SA
        • GSK Investigational Site
      • Hull, United Kingdom, HU12 8JD
        • GSK Investigational Site
      • Irlam, Manchester, United Kingdom, M44 5LH
        • GSK Investigational Site
      • Larbet, United Kingdom, FK5 4WR
        • GSK Investigational Site
      • Manchester, United Kingdom, M28 1PB
        • GSK Investigational Site
      • Newport, United Kingdom, NP20 4SZ
        • GSK Investigational Site
      • Newport, Isle Of Wight, United Kingdom, PO30 5TG
        • GSK Investigational Site
      • Poole, United Kingdom, BH15 2HX
        • GSK Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • GSK Investigational Site
      • Swinton, United Kingdom, M27 4AF
        • GSK Investigational Site
      • Warrington, United Kingdom, WA2 7NJ
        • GSK Investigational Site
    • Cambridgeshire
      • Soham, Cambridgeshire, United Kingdom, CB7 5JD
        • GSK Investigational Site
    • Carmarthenshire
      • Llanelli, Carmarthenshire, United Kingdom, SA14 8QF
        • GSK Investigational Site
    • Cheshire
      • Bollington, Cheshire, United Kingdom, SK10 5JH
        • GSK Investigational Site
      • Macclesfield, Cheshire, United Kingdom, SK11 6JL
        • GSK Investigational Site
      • Sandbach, Cheshire, United Kingdom, CW11 1EQ
        • GSK Investigational Site
    • Denbighshire
      • Rhyl, Denbighshire, United Kingdom, LL18 1DA
        • GSK Investigational Site
    • Hampshire
      • Waterlooville, Hampshire, United Kingdom, PO8 8DL
        • GSK Investigational Site
    • Lanarkshire
      • Wishaw, Lanarkshire, United Kingdom, ML2 0DP
        • GSK Investigational Site
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN17 2UR
        • GSK Investigational Site
      • Wellingborough, Northamptonshire, United Kingdom, NN8 4RW
        • GSK Investigational Site
    • Suffolk
      • Leiston, Suffolk, United Kingdom, IP16 4ES
        • GSK Investigational Site
    • Sussex East
      • Bexhill, Sussex East, United Kingdom, TN40 1JJ
        • GSK Investigational Site
    • Tyne & Wear
      • Gateshead, Tyne & Wear, United Kingdom, NE8 2PQ
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TRELEGY ELLIPTA (FF/UMEC/VI: 100 mcg/62.5 mcg/25 mcg)
Eligible subjects will receive a blended combination of FF in the first strip (100 mcg per blister) and UMEC/VI in second strip (62.5 mcg UMEC per blister and 25 mcg VI per blister), a single inhalation once daily in the morning in the same TRELEGY ELLIPTA Dry Powder Inhaler (DPI) via inhalation route for a period of 24 weeks. Study treatment may be augmented with other prescribed COPD medications such as including rescue medications, which will be prescribed and obtained according to usual practice.
Drug: FF/UMEC/VI
FF is a dry white powder containing 100 mcg GW685698 blended with lactose in one blister in the first strip of the DPI. UMEC/VI is a dry white powder containing 62.5 mcg of UMEC and 25 mcg of VI per blister, both blended together with lactose and magnesium stearate in the second strip of the DPI.
Drug: COPD rescue medications
Rescue medications for COPD will be prescribed and obtained according to usual practice.
Active Comparator: Non-ELLIPTA MITT
Eligible subjects will receive the ICS/LAMA/LABA products twice daily and dosing regimens as prescribed by their physician for a period of 24 weeks. Study treatment may be augmented with other prescribed COPD medications such as including rescue medications, which will be prescribed and obtained according to usual practice.
Drug: COPD rescue medications
Rescue medications for COPD will be prescribed and obtained according to usual practice.
Drug: Inhaled Corticosteroid
Inhaled Corticosteroid (ICS) as prescribed by the physician.
Drug: LAMA
LAMA as prescribed by the physician.
Drug: LABA
LABA as prescribed by the physician.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24
Time Frame: Baseline (Day 1) and 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.
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
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.
At Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 206854
  • 2017-004369-29 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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 Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

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