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An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma

NCT01706198 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4233

Last updated 2019-01-24

Study results available
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Summary

This study is designed to compare the effectiveness and safety of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma. This is a Phase III multi-centre, randomised open label study. Subjects who meet the eligibility criteria are randomised and will enter a 12 month treatment period.

Conditions

Interventions

DRUG

fluticasone furoate + vilanterol

once daily via a Novel Dry Powder Inhaler

DRUG

inhaled corticosteroid with or without a long acting beta2-agonist

ICS alone or in combination with a long acting bronchodilator

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-01
Primary Completion
2016-12-01
Completion
2016-12-16

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01706198 on ClinicalTrials.gov