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Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children

NCT01573767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 463

Last updated 2017-01-09

Study results available
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Summary

This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and salbutamol/albuterol as required to use throughout the run-in and double-blind treatment period. At Visit 3 subjects meeting the randomization eligibility criteria will receive vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI) once daily for 4 weeks in addition to open-label fluticasone propionate twice daily throughout the treatment period. Primary endpoints consist of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period in all subjects. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at specific time intervals relative to the dose of study drug.

Conditions

Interventions

DRUG

Fluticasone propionate 100mcg

all subjects recieve open-label Flovent twice daily duirng the run in and treatment period

DRUG

Placebo

Placebo inhalation powder during treatment period

DRUG

Vilanterol

subjects will recieve 4 weeks via NDPI during treament period

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • Argentina
  • Chile
  • Georgia
  • Germany
  • Japan
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Puerto Rico
  • Slovakia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT01573767 on ClinicalTrials.gov