Phase 2
Completed N=456
Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children
Source: ClinicalTrials.gov NCT01573767 ↗Enrolled (actual)
456
Serious AEs
0.2%
Results posted
Apr 2015
Primary outcomePrimary: Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period — 215.9; 221.4; 222.4; 220.3 Liters per minute (L/min) — p=0.227
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period |
215.9; 221.4; 222.4; 220.3 | 0.227 |
| SECONDARY Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 4-week Treatment Period in Children Who Could Perform the Maneuver |
0.223; 0.166; 0.240; 0.193 | — |
| SECONDARY Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 4-week Treatment Period |
14.4; 12.2; 15.8; 2.98 | — |
| SECONDARY Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period |
6.4; 12.0; 13.9; 13.7 | — |
| SECONDARY Change From Baseline in Evening (PM) PEF Over the Last 7 Days of the Treatment Period (Week 4) |
5.9; 9.4; 13.7; 11.1 | — |
| SECONDARY Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4) |
7.4; 13.3; 17.0; 14.4 | — |
| SECONDARY Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 4-week Treatment Period |
9.9; 10.1; 18.3; 19.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01573767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.