Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children
Public ClinicalTrials.gov record NCT01573767. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children Aged 5-11 Years With Asthma on a Background of Inhaled Corticosteroid Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01573767
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 463 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2012
- Primary completion
- Mar 31, 2014
- Completion
- Mar 31, 2014
- Last update posted
- Jan 8, 2017
2012 – 2014
United States locations
- U.S. sites
- 34
- U.S. states
- 19
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35209 | — |
| GSK Investigational Site | Mobile | Alabama | 36608 | — |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | — |
| GSK Investigational Site | Huntington Beach | California | 92647 | — |
| GSK Investigational Site | Long Beach | California | 90808 | — |
| GSK Investigational Site | Mission Viejo | California | 92691 | — |
| GSK Investigational Site | Newport Beach | California | 92663 | — |
| GSK Investigational Site | Orange | California | 92868 | — |
| GSK Investigational Site | Rolling Hills Estates | California | 90274 | — |
| GSK Investigational Site | Aventura | Florida | 33180 | — |
| GSK Investigational Site | Miami | Florida | 33173 | — |
| GSK Investigational Site | Tampa | Florida | 33613 | — |
| GSK Investigational Site | Columbus | Georgia | 31904 | — |
| GSK Investigational Site | Savannah | Georgia | 31406 | — |
| GSK Investigational Site | Normal | Illinois | 61761 | — |
| GSK Investigational Site | Shiloh | Illinois | 62269 | — |
| GSK Investigational Site | Lenexa | Kansas | 66215 | — |
| GSK Investigational Site | Nicholasville | Kentucky | 40356 | — |
| GSK Investigational Site | White Marsh | Maryland | 21162 | — |
| GSK Investigational Site | Columbia | Missouri | 65203 | — |
| GSK Investigational Site | Omaha | Nebraska | 68107 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | — |
| GSK Investigational Site | Dayton | Ohio | 45414 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | — |
| GSK Investigational Site | Charleston | South Carolina | 29406 | — |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | — |
| GSK Investigational Site | Austin | Texas | 78750 | — |
| GSK Investigational Site | Dallas | Texas | 75230 | — |
| GSK Investigational Site | Spring | Texas | 77379 | — |
| GSK Investigational Site | Waco | Texas | 76712 | — |
| GSK Investigational Site | South Burlington | Vermont | 05403 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 86 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01573767, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 8, 2017 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01573767 live on ClinicalTrials.gov.