INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
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ClinicalTrials.gov Identifier: NCT03467425 |
Recruitment Status :
Completed
First Posted : March 16, 2018
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | February 2, 2018 | ||||||||||||||||||
First Posted Date ICMJE | March 16, 2018 | ||||||||||||||||||
Results First Submitted Date ICMJE | August 19, 2020 | ||||||||||||||||||
Results First Posted Date ICMJE | September 7, 2020 | ||||||||||||||||||
Last Update Posted Date | September 7, 2020 | ||||||||||||||||||
Actual Study Start Date ICMJE | April 11, 2018 | ||||||||||||||||||
Actual Primary Completion Date | October 10, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Number of responders based on CAT at Week 24 [ Time Frame: Week 24 ] The CAT is a subject-completed instrument designed to provide a simple and reliable measure of health status in COPD for the assessment and long-term follow-up of the individual subject. The CAT consists of eight items, each formatted on a semantic differential scale. Subjects rated their experience on a 6-point scale for each question, ranging from 0 to 5 with a maximum total score of 40. Higher scores indicate greater disease impact. CAT of each subject was assessed at Baseline (Week 1) and Week 24 or Early withdrawal. Responders are the subjects who will have the change from Baseline of CAT score >=2 at Week 24. Number of responders based on CAT at Week 24 will be presented.
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Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design | ||||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||||
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. | ||||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Phase 4 | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention 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)Primary Purpose: Treatment |
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Condition ICMJE | Pulmonary Disease, Chronic Obstructive | ||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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). pii: 00061-2019. doi: 10.1183/23120541.00061-2019. eCollection 2019 Oct. | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||
Actual Enrollment ICMJE |
3109 | ||||||||||||||||||
Original Estimated Enrollment ICMJE |
3000 | ||||||||||||||||||
Actual Study Completion Date ICMJE | October 10, 2019 | ||||||||||||||||||
Actual Primary Completion Date | October 10, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years and older (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | Germany, Netherlands, Spain, Sweden, United Kingdom | ||||||||||||||||||
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Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT03467425 | ||||||||||||||||||
Other Study ID Numbers ICMJE | 206854 2017-004369-29 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | GlaxoSmithKline | ||||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||||
Current Study Sponsor ICMJE | GlaxoSmithKline | ||||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | GlaxoSmithKline | ||||||||||||||||||
Verification Date | July 2020 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |