Phase 4
N=463
To Evaluate Real-World Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol (FF/UMEC/VI) in a Single Inhaler (Trelegy Ellipta) in Participants With Symptomatic COPD
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT05535972 ↗Enrolled (actual)
463
Serious AEs
4.1%
Results posted
Nov 2024
Primary outcome: Primary: Change From Baseline in COPD Assessment Test (CAT) Score at Week 12 — -6.8 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- FF/UMEC/VI (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in COPD Assessment Test (CAT) Score at Week 12 |
-6.8 | — |
| SECONDARY Change From Baseline in Modified Medical Research Council (mMRC) Grading System at Week 12 (Patient Version) |
-0.5 | — |
| SECONDARY Change From Baseline in Modified Medical Research Council (mMRC) Dyspnea Scale at Week 12 (Physician Version) |
-0.5 | — |
| SECONDARY Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) at Week 12 |
0.132 | — |
| SECONDARY Percentage of Participants Having >=2 Unit Decrease in CAT Score From Baseline at Week 12 |
86.0 | — |
| SECONDARY Change From Baseline in COPD Assessment Test (CAT) Score at Week 4 |
-4.4 | — |
| SECONDARY Number of Participants With Trelegy Related Non-serious Adverse Events (AEs) |
9 | — |
| SECONDARY Number of Participants With Trelegy Related Serious Adverse Events (SAEs) |
1 | — |
| SECONDARY Number of Participants With Trelegy Related AEs Leading to the Discontinuation |
5 | — |
Summary
The primary objective of this study is to evaluate the effectiveness of TRELEGY ELLIPTA on health status in participants with symptomatic COPD. The secondary objective is to evaluate the effectiveness of TRELEGY ELLIPTA on dyspnea and lung function in participants with symptomatic COPD. TRELEGY and ELLIPTA are trademarks of the GlaxoSmithKline group of companies.
Eligibility Criteria
Inclusion Criteria
- Participant must be 40 years or above of age inclusive, at the time of signing the informed consent.
- Participants with a documented physician diagnosis of COPD.
- CAT greater than or equal to (≥) 10.
- Existing COPD Maintenance Treatment. Participants currently receiving one of the maintenance therapies given below who have been prescribed it continually for at least 12 weeks prior to screening (Visit 1): Inhaled Corticosteroids/ Long-Acting Beta-2-Agonists (ICS/LABA) (single or multiple inhalers); Long-Acting Muscarinic Antagonist (LAMA)/LABA (single or multiple inhalers); Free combination of inhaled corticosteroids (ICS), LAMA, LABA.
- Current or former cigarette smokers with a history of cigarette smoking history ≥10 pack-years at screening.
- Trelegy is prescribed under the discretion of clinical physicians with medical records providing documentation of a Trelegy prescription in daily practice.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria
- Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- Prescribed with Trelegy within one year prior to screening (Visit 1).
- Participants 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.
- Participants with any life-threatening condition i.e. low probability, in the opinion of the investigator, of 3-month survival due to severity of COPD or comorbid condition.
- Participants with unstable COPD. Participants with resolution of an exacerbation less than 2 weeks prior to Visit 1. Participants may be rescreened 2 weeks after resolution of exacerbation (exacerbation is defined as: requiring treatment with antibiotics and/or systemic steroids or hospitalization; resolution is defined as: 2 weeks after all symptoms have resolved and any medicines to treat the exacerbation have finished).
- Participants who need more than 3 liter per minute (L/min) supplemental oxygen at rest at screening.
- Other diseases/abnormalities: Participants 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 efficacy or safety analysis if the disease/condition exacerbated during the study.
- Participant received any investigational drug in other clinical trial within four weeks or 5 half-lives prior to this study whichever is longer.
- Any conditions or illnesses listed in the section of contraindications in the Summary of Product Characteristics (SmPC) of Trelegy, i.e., hypersensitivity to the active substances of TRELEGY ELLIPTA.
- Participants with known COVID-19 positive contacts within the past 14 days.
- Inability to read: In the opinion of the Investigator, any participant who is unable to read and/or would not be able to complete study related materials.
Data sourced from ClinicalTrials.gov (NCT05535972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.