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A Study to Compare the Efficacy and Safety of Fluticasone Furoate (FF) 100 mcg Once Daily With Fluticasone Propionate (FP) 250 mcg Twice Daily (BD) and FP 100 mcg BD in Well-controlled Asthmatic Japanese Subjects

NCT02094937 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2017-05-25

Study results available
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Summary

The primary aim of this study is to clarify the position of FF and FF/Vilanterol (VI) 100/25 micrograms (mcg) compared with existing therapies by assessing FF dosage equivalent to low to middle-dose inhaled corticosteroids (ICS). The study is divided into Run-in period, Period 1 (open-label treatment), Period 2 (double blind treatment) and Follow-up. Subjects with well controlled asthma after completing a run-in period of 4 weeks will be switched from middle-dose ICS/long acting beta 2 agonist (LABA) equivalent dose to once-daily FF/VI 100/25 mcg for an 8 weeks treatment period (Period 1). After this, subjects will be randomized in a 1:1:1 ratio to receive either FP 250 mcg twice daily, FP 100 mcg twice daily or FF 100 mcg once daily in a 12 week double blind treatment period (Period 2). There will be a 1 week Follow-up Period following completion of the double-blind treatment period, or early withdrawal from the study. Overall , the total duration of subject's participation in the study will be for 25 weeks. RELVAR is a registered trademark of the GSK group of companies.

Conditions

Interventions

DRUG

Fluticasone Furoate/Vilanterol

FF/VI 100mg/25 mcg is available as a dry white powder to be given once daily in the evening via dry powder inhaler

DRUG

Fluticasone Furoate 100 mcg

FF 100 mcg is available as a dry white powder to be given once daily in the evening via dry powder inhaler

DRUG

Fluticasone Propionate 250 mcg

FP 250 mcg is available as a dry white powder to be given twice daily (morning and evening) via dry powder inhaler

DRUG

Fluticasone Propionate 100 mcg

FP 100 mcg is available as a dry white powder to be given twice daily (morning and evening) via dry powder inhaler

DRUG

Fluticasone Furoate Placebo

Matching placebo of Fluticasone Furoate will be given once daily in the evening via dry powder inhaler

DRUG

Fluticasone Propionate Placebo

Matching placebo of Fluticasone Propionate will be given twice daily (morning and evening) via dry powder inhaler

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-27
Primary Completion
2015-08-28
Completion
2015-08-28

Countries

  • Japan

Study Locations

More Related Trials

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 NCT02094937 on ClinicalTrials.gov