Last updated: 06/15/2021 13:20:05
INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of responders based on CAT at Week 24
Timeframe: Week 24
Secondary outcomes:
Change from Baseline in forced expiratory volume in 1 second (FEV1) at Week 24
Timeframe: Baseline and Week 24
Number of subjects making at least 1 critical error in inhalation technique at Week 24
Timeframe: Week 24
Interventions:
Enrollment:
3109
Primary completion date:
2019-10-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
David M.G. Halpin, Sally Worsley, Afisi S. Ismaila, Kai-Michael Beeh, Dawn Midwinter, Janwillem W.H. Kocks, Elaine Irving, Jose M. Marin, Neil Martin, Maggie Tabberer, Neil G. Snowise, Chris Compton. INTREPID: single- versus multiple-inhaler triple therapy for COPD in usual clinical practice. ERJ Open Res. 2021;7(2):00950-2020
DOI: 10.1183/23120541.00950-2020
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
April 2018 to October 2019
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Capable of giving signed informed consent.
- Subjects with a documented physician diagnosis of COPD.
- 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.
Inclusion and exclusion 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).
Trial location(s)
Showing 1 - 6 of 143 Results
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2019-10-10
Actual study completion date
2019-10-10
Plain language summaries
Summary of results in plain language
Available language(s): English, Dutch, German, Spanish, Swedish
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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