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.

The primary purpose of this study is to evaluate the safety and efficacy of a single inhaler triple therapy combination of FF/UMEC/VI (100mcg/62.5mcg/25mcg) administered once daily via the ELLIPTAâ„¢ inhaler, following 12 weeks of treatment.

Overall Design:

This is a phase IV, 12-week, single arm, multi-centre study evaluating single inhaler triple therapy (FF/UMEC/VI) once daily via the ELLIPTA (see Section 1.2 for study schematic). The target enrolment is 252 participants to enter the run-in period, at approximately 20 study centers in India. Participants will enter run-in on their existing COPD medication for 2 weeks. To ensure the participants enrolled are representative of the population that may be eligible for single inhaler triple therapy in India, prescription data from India will be used to cap the approximate number of patients enrolled on the

most widely prescribed COPD medications. At the end of the run-in period and start of the treatment period, participants will discontinue all existing COPD medications but may continue their study-supplied rescue salbutamol on an as-needed basis (rescue medication) throughout the study.

Clinic Visits will occur at Pre-Screening (Visit 0), Screening (Visit 1), Start of Treatment (Day 1, Visit 2), Day 28 (Visit 3), Day 84 (Visit 4) and Day 85 (Visit 5). A safety followup (Visit 6) telephone contact or clinic visit will be conducted 1 week after completing the 12-week treatment period. Participants will sign an informed consent form (ICF) at a Pre-Screen or Screening Visit and will be assigned a participant identifier.

Number of Participants:

Approximately 336 participants will be screened in order to recruit 252 participants to the

study run-in (assuming 25% screen failure) and 229 to the study treatment phase

(assuming 9% run-in failure) and achieve 220 evaluable participants at the end of the

study (assuming 4% withdrawal from study treatment).

Intervention Groups and Duration:

Participants who meet all the eligibility criteria and who have successfully completed all

protocol procedures at screening will enter the 2-week run-in period. Following the runin

period, eligible participants will receive the following study intervention for 12 weeks:

FF/UMEC/VI 100mcg/62.5mcg/25mcg via the ELLIPTA inhaler once daily in the

morning

On the morning of study clinic Visit 2 (start of treatment), Day 28 (Visit 3) and Day 84

(Visit 4), participants will refrain from taking their morning dose of study

intervention/COPD medication until instructed to do so by clinic personnel. Participants

will take their last dose of study treatment in the clinic on Day 84 and will return for their

final clinical assessments on Day 85 (Visit 5). A safety follow-up (Visit 6) will be

conducted either by phone call or clinic visit approximately one week later. Participants

may continue their study-supplied rescue salbutamol from the start of the run-in period

until the end of the treatment period.

A participant will be considered to have completed the study when they have completed

all phases of the study including screening, run-in, the treatment phase, and safety followup.

The total duration of participant participation will be approximately 15 weeks, consisting

of a 2-week run-in period, 12-week treatment period and a 1-week follow-up period.

Participants that permanently discontinue study intervention are not required to withdraw

from the study. If for any reason a participant must permanently discontinue study

treatment, every effort should be made by the investigator/staff to keep the participant in

the study. However, a participant may voluntarily withdraw from participation in this

study at any time. The investigator may also, at his or her discretion, withdraw a

participant from further study participation. Participants who are withdrawn from the

study will not be replaced.