INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: FF/UMEC/VI; Inhaled Corticosteroid; LAMA; LABA; COPD rescue medications
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.; Inhaled Corticosteroid (ICS) as prescribed by the physician.; LAMA as prescribed by the physician.; LABA as prescribed by the physician.; Rescue medications for COPD will be prescribed and obtained according to usual practice.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 3109.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: FF/VI/UMEC; TRELEGY ELLIPTA; COPD; Effectiveness

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.
    

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).