Study to evaluate the effect of fluticasone furoate/vilanterol on survivalin subjects with chronic obstructive pulmonary disease who have history of cardiovascular disease.

Phase 3

Active, not recruiting

• Conditions: Moderate Chronic Obstructive Pulmonary Disease and a history of or at increased risk for cardiovascular disease

• Registration Number: CTRI/2012/04/002563
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a randomized, double-blind, parallel-group, multi-center, placebo-controlled study to evaluate the long term efficacy and safety of Fluticasone furoate and Vilanterol Inhalation powder 100/25mcg Once Daily, Fluticasone furoate Inhalation powder 100mcg Once Daily and Vilanterol Inhalation  powder 25mcg Once Daily when administered via the Novel Dry Powder Inhaler. Once daily dosing will occur in the morning (with the exception of the first treatment visit). The target enrolment is approximately 16,000 randomized subjects at approximately 1600 study centers globally. Based on current assumptions of the event rate, the total duration of subject participation will be approximately between 15 and 44 months, consisting of a 4-10 day run-in period, variable treatment period and 1-week follow-up period.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-21
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 16000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival in subjects with moderate COPD (≥50% and ≤70 % predicted Forced Expiratory Volume in One Second - FEV1) with a	Time to death from any cause
history of, or at increased risk for cardiovascular disease	Time to death from any cause

Secondary Outcome Measures

Name	Time	Method
The rate of decline in Forced Expiratory Volume in One Second (FEV1) as the effect of Fluticasone Furoate and Vilanterol compared with placebo	Rate of decline in Forced Expiratory Volume in One Second (FEV1)
A cardiovascular composite endpoint comprised of on-treatment Cardiovascular death, myocardial infarction, stroke, unstable angina and TIA on the the effect of Fluticasone Furoate/Vilanterol compared with placebo	Time to Cardiovascular event

Trial Locations

Locations (26)

Aaditya Adikari Hospital; 🇮🇳 Mysore, KARNATAKA, India

Allergy Asthma Associates; 🇮🇳 Mysore, KARNATAKA, India

Andhra Hospitals; 🇮🇳 Krishna, ANDHRA PRADESH, India

Apollo Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

Aware Global Hospitals; 🇮🇳 Telangana,, India

AXON Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Chaitanya Nursing Home; 🇮🇳 Pune, MAHARASHTRA, India

Chennai Thoracic and Research Institute; 🇮🇳 Chennai, TAMIL NADU, India

Chest and Maternity Center; 🇮🇳 Bangalore, KARNATAKA, India

Chest Research Foundation; 🇮🇳 Pune, MAHARASHTRA, India

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Aaditya Adikari Hospital

🇮🇳Mysore, KARNATAKA, India

Dr Upadya Haridas

Principal investigator

09880046375

dr.upadya@gmail.com