Clinical trial NCT04923347: A Study to Evaluate the Safety and Efficacy of Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI) in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Phase IV, 12-week, Single Arm, Open Label Study Evaluating the Safety and Efficacy of Fixed Dose Triple Combination FF/UMEC/VI Administered Once Daily in the Morning Via a Dry Powder Inhaler in Participants With Chronic Obstructive Pulmonary Disease in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease
ELLIPTA
Fluticasone Furoate
Umeclidinium
Vilanterol
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-06-11
Enrollment: 229
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will receive FF/UMEC/VI via ELLIPTA inhaler.
Primary purpose: TREATMENT

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.


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 \<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.

Exclusion Criteria:

* 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.
* Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy \>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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESIs)
timeFrame: Up to approximately 40 weeks
Secondary outcomes:
measure: Change From Baseline (CFB) in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 28 and Day 85
timeFrame: Baseline (Day 1), Day 28 and Day 85
Other outcomes:
Locations:
city: Ajmer
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bikaner
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Jaipur
country: India
facility: GSK Investigational Site
city: Kolkata
country: India
facility: GSK Investigational Site
city: Kolkata
country: India
facility: GSK Investigational Site
city: Kozhikode
country: India
facility: GSK Investigational Site
city: Mumbai
country: India
facility: GSK Investigational Site
city: Mysore
country: India
facility: GSK Investigational Site
city: Nagpur
country: India
facility: GSK Investigational Site
city: Nashik
country: India
facility: GSK Investigational Site
city: Pondy-Cuddalore ECR Main Road Pillaiyarkuppam Pond
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: