Phase 4
N=229
A Study to Evaluate the Safety and Efficacy of Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI) in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT04923347 ↗Enrolled (actual)
229
Serious AEs
0.4%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs) — 35; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- FF/UMEC/VI (Drug); ELLIPTA (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs) |
35; 1; 0 | — |
| SECONDARY Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 28 and Day 85 |
1.3645; 0.0542; 0.0317 | — |
Summary
This study will evaluate safety and efficacy of FF/UMEC/VI via ELLIPTA® inhaler. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.
Eligibility Criteria
Inclusion criteria
- A signed and dated written informed consent prior to study participation
- Participants 40 years of age or older at Screening (Visit 1)
- Male and female participants will be included in the study. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the treatment period and until the safety follow-up contact after the last dose of study intervention.
- An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.
- Current or former cigarette smokers with a history of cigarette smoking of greater than equal to (>=)10 pack-years at Screening (Visit 1) (number of pack years = [number of cigarettes per day divided by 20] times number of years smoked [for example 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- Participant with history of >=2 moderate exacerbations or one severe (hospitalized) exacerbation in the previous 12 months, and with a score of >=10 on the COPD Assessment Test (CAT) eligible for the study treatment in the opinion of the investigator and documented post salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of =12 percent (%) and >=200 milliliter (mL) following administration of salbutamol. Participants defined as non-reversible will have a post-salbutamol increase in FEV1 of =200mL increase that is 3 Liters per minute (L/min) at screening (Oxygen use <=3L/min flow at rest is not exclusionary.)
- Participants must not start the acute phase of a pulmonary rehabilitation program within the 4 weeks prior to Visit 1.
- Participants who are medically unable to withhold their salbutamol for the 4-hour period required prior to spirometry testing at each study visit.
- In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete study related materials.
- Use of the following medications within the following time intervals prior to Visit 1 or during the study:
- Participants receiving antibiotics for long term therapy are not eligible for the study.
- No use of systemic, Oral, parenteral corticosteroids within 30 days prior to screening (Intra-articular injections are allowed).
- No use of any other investigational drug within 30 days or 5 half-lives whichever is longer prior to screening.
Data sourced from ClinicalTrials.gov (NCT04923347). 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.