A Study to Evaluate the Safety and Efficacy of Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI) in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT04923347 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 212655
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease; ELLIPTA; Fluticasone Furoate; Umeclidinium; Vilanterol

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other important medical event according to medical or scientific judgement. Protocol defined AESIs were included. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary).

  Up to approximately 40 weeks

Secondary Outcomes (1)

• Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 28 and Day 85

  Baseline (Day 1), Day 28 and Day 85

Study Arms (1)

Participants receiving FF/UMEC/VI via ELLIPTA inhaler

EXPERIMENTAL

Drug: FF/UMEC/VI; Device: ELLIPTA

Interventions

FF/UMEC/VI DRUG

FF/UMEC/VI will be administered

Participants receiving FF/UMEC/VI via ELLIPTA inhaler

ELLIPTA DEVICE

Participants will receive FF/UMEC/VI using ELLIPTA inhaler.

Participants receiving FF/UMEC/VI via ELLIPTA inhaler

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<0.70
• Participant must be receiving daily long-acting maintenance treatment for their COPD for at least 3 months prior to Screening. To be eligible for the study treatment phase, participants must be compliant with their existing COPD maintenance therapy (in the opinion of the investigator) for the preceding two weeks prior to screening.
• A negative test for active Coronavirus Disease 2019 (COVID-19) at Visit 1. The test should be done using a molecular (Polymerase chain reaction \[PCR\] or antigen test) approved by the country regulatory authorities.

You may not qualify if:

• Women who are pregnant or lactating or are planning on becoming pregnant during the study.
• Participants with a current diagnosis of asthma. (Participants with a prior history of asthma are eligible if they have a current diagnosis of COPD).
• Documented (medical records) evidence of reversibility. Reversibility is defined as an increase in FEV1 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 or a \>=200mL increase that is \<12% from pre-salbutamol baselineParticipants with alpha 1-antitrypsin deficiency as the underlying cause of COPD.
• Participants with active tuberculosis, lung cancer, and clinically significant (in the opinion of the investigator): bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
• Participants with lung volume reduction surgery within the 12 months prior to Screening
• Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids and/or antibiotics (if applicable). In addition, any participant that experiences pneumonia and/or moderate or severe COPD exacerbation within the preceding two weeks prior to screening will be excluded.
• Respiratory tract infection that has not resolved at least 7 days prior to Screening.
• Participants with known COVID-19 positive contacts within the past 14 days should be excluded for at least 14 days since the exposure and the participant remains symptom free. Participants with symptoms suggestive of active COVID-19 infection e.g. fever, cough (new or worsened), etc. are also excluded.
• Chest x-ray (poster anterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on chest x-ray (CXR) (e.g. significant cardiomegaly, pleural effusion or scarring).
• Participants with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled.
• Abnormal and clinically significant 12-lead electrocardiogram (ECG) finding at Visit 1.
• 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:

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (14)

GSK Investigational Site

Ajmer, 305001, India

Location

GSK Investigational Site

Bangalore, 560092, India

Location

GSK Investigational Site

Bikaner, 334001, India

Location

GSK Investigational Site

Hyderabad, 500084, India

Location

GSK Investigational Site

Jaipur, 302039, India

Location

GSK Investigational Site

Kolkata, 700014, India

Location

GSK Investigational Site

Kolkata, 700027, India

Location

GSK Investigational Site

Kozhikode, 673008, India

Location

GSK Investigational Site

Mumbai, 401107, India

Location

GSK Investigational Site

Mysore, 57001, India

Location

GSK Investigational Site

Nagpur, 44009, India

Location

GSK Investigational Site

Nashik, 422007, India

Location

GSK Investigational Site

Pondy-Cuddalore ECR Main Road Pillaiyarkuppam Pond, 605402, India

Location

GSK Investigational Site

Pune, 411047, India

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: This will be an open-label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive FF/UMEC/VI via ELLIPTA inhaler.

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 11, 2021
• Study Start: June 6, 2023
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

IN (14)