Single Inhaler Triple Therapy (fluticasone furoate + vilanterol trifenatate + umeclidinium bromide) (inhaled) - COPD

Phase 1

• Conditions: Chronic 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]

• Registration Number: EUCTR2017-004369-29-ES
• Lead Sponsor: GlaxoSmithKline, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-21
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 3000

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)
- LAMA and LABA used in combination as a dual therapy
- LABA and ICS used in combination as a dual therapy
NOTE: patients 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.
Patients who are receiving only COPD medication on an ‘as required’ basis are not eligible.
6. Age and Sex: participants must be aged = 40 years of age at the time of signing the informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 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.
7. Participants currently participating in any interventional clinical study.
Participants 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified