Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 5 - 11 |
| Updated: | 5/3/2014 |
| Start Date: | April 2012 |
| End Date: | June 2014 |
| Contact: | US GSK Clinical Trials Call Center |
| Email: | GSKClinicalSupportHD@gsk.com |
| Phone: | 877-379-3718 |
A Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children Aged 5-11 Years With Asthma on a Background of Inhaled Corticosteroid Therapy
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.
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.
Inclusion Criteria:
- Written informed consent from at least one parent/ legal guardian to take part in the
study.:
- Diagnosis of asthma
- pre-bronchodilator PEF between ≥50% to ≤90% of their best post-bronchodilator value
- Receiving stable asthma therapy of short acting beta-agonist (SABA) plus ICS (total
daily dose FP 200mcg or equivalent)
Exclusion Criteria:
- history of life-threatening asthma
- history of asthma exacerbation for asthma within 6 months prior to screening.
- Culture-documented or suspected bacterial or viral infection
- significant abnormality or medical condition
- Present use of any tobacco products
We found this trial at
35
sites
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