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A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma

NCT02446418 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 423

Last updated 2019-01-14

Study results available
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Summary

The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a once-daily combination therapy for the long-term maintenance treatment of asthma in adults and children \>=12 years of age. Pivotal phase III studies have demonstrated the safety and efficacy of FF/VI in asthma. However, it is increasingly acknowledged that randomised clinical trials tend to be highly controlled and enrol a more highly selected subject population than is expected to be prescribed the medication post-approval. There is a need for data in a more representative population in close to a 'real life' conditions, where physicians have the ability to choose the best treatment in their view for any individual subject and adapt treatments to subjects' characteristics and response. This multi-center, open-label, randomized, parallel group study will evaluate the efficacy and safety of FF/VI compared with two usual ICS/LABA fixed combination (fluticasone propionate/salmeterol \[FP/S\] or budesonide/formoterol \[BUD/F\]) in subjects with persistent asthma, in a "close to real life" settings. FF/VI will be administered once-daily (QD) via ELLIPTA dry powder inhaler (DPI) and FP/S or BUD/F will be administered twice daily (BID) via DISKUS™ and TURBUHALER™ DPI respectively. ELLIPTA is a new powder inhaler designed to be easy to use. The total duration of subject participation will be approximately 6 months (24 weeks). ELLIPTA and DISKUS are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca.

Conditions

Interventions

DRUG

Fluticasone Furoate

FF 92 mcg or 184 mcg blended with lactose administered once daily via ELLIPTA DPI

DRUG

Vilanterol

Vilanterol 22 mcg blended with lactose and magnesium stearate administered once daily via ELLIPTA DPI

DRUG

Fluticasone propionate

FP 250 mcg or 500 mcg blended with lactose administered twice daily via DISKUS DPI

DRUG

Salmeterol

Salmeterol 50 mcg blended with lactose administered twice daily via DISKUS DPI

DRUG

Budesonide

Budesonide 200 mcg or 400 mcg blended with lactose administered twice daily via TURBUHALER DPI

DRUG

Formoterol Fumarate

Formoterol Furoate 6 mcg or 12 mcg blended with lactose administered twice daily via TURBUHALER DPI

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-09
Primary Completion
2017-07-20
Completion
2017-07-20

Countries

  • France
  • Germany

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 NCT02446418 on ClinicalTrials.gov