The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in a Single Inhaler (TRELEGYTM ELLIPTATM) when Compared with Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients within a Usual Care Setting. Short Title: INTREPID: INvestigation of TRELEGY Effectiveness: Usual PractIce Design

GlaxoSmithKline Research & Development Limited0 sites3,000 target enrollmentFebruary 19, 2018

ConditionsChronic Obstructive Pulmonary Disease (COPD) which may be called emphysema or chronic bronchitis.MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855 Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

DrugsTrelegy Ellipta

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease (COPD) which may be called emphysema or chronic bronchitis.
Sponsor: GlaxoSmithKline Research & Development Limited
Enrollment: 3000
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 19, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

GlaxoSmithKline Research & Development Limited

Eligibility Criteria

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the following criteria apply:
•1\. Informed Consent: Capable of giving signed informed consent as described in Appendix 2 of study protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
•2\. COPD Diagnosis: Patients with a documented physician diagnosis of COPD.
•3\. Severity of COPD symptoms: A score of \=10 on the COPD Assessment Test (CAT) at screening.
•4\. History of Exacerbations. Patients who have a history of treatment with systemic/oral corticosteroids, antibiotics and/or hospitalisation for at least one COPD exacerbation in the 3 years prior to randomisation. This will be captured through patient recall and/or medical records and must be documented in patients 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.
•5\. Existing COPD Maintenance Treatment. Patients currently receiving one of the non\-ELLIPTA maintenance therapies listed below who have been prescribed it continually for at least 16 weeks prior to randomisation.
•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
•\- ICS in combination with LAMA and LABA (MITT)

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•1\. Women of child bearing potential. as defined in Appendix 4 of study protocol. This includes women who are pregnant or lactating or are planning on becoming pregnant during the study.
•2\. Medical Conditions: Patients 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.
•3\. Patients with unstable COPD. Patients with resolution of an exacerbation less than 2 weeks prior to visit 1, must not be randomised. Patients may be rescreened 2 weeks after resolution of exacerbation (exacerbation is defined by treatment with systemic
•corticosteroids and/or antibiotic).
•4\. Other diseases/abnormalities: patients 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 participant at risk through participation, or which would affect the effectiveness or safety analysis if the
•disease/condition exacerbated during the study
•5\. Hypersensitivity: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, ß2\-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.
•6\. Prior/Concomitant Therapy with Oral Corticosteroid Patients who, in the opinion of the treating investigator, are chronic users of oral