Overview

INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design

Status:
Completed
Trial end date:
2019-10-10
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
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).