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Inhaled Fluticasone Furoate/Vilanterol Safety and Tolerability, PK and PD Study

NCT01453023 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-01-11

Study results available
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Summary

This study will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics of fluticasone furoate/vilanterol (FF/VI) 100/25mcg administered using the novel dry powder inhaler in children aged 5 to 11 years with persistent asthma.

Conditions

Interventions

DRUG

Fluticasone Furoate

100mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period.

DRUG

Fluticasone Furoate/Vilanterol

100/25 mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

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 NCT01453023 on ClinicalTrials.gov