Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year
Public ClinicalTrials.gov record NCT02889809. 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
Study HZA114971, A Multicentre Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of a One-Year Regimen of Orally Inhaled Fluticasone Furoate 50 mcg Once Daily on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
There is a regulatory requirement to evaluate the extent of reduction (if any) of growth velocity associated with inhaled corticosteroid (ICS) containing products that are to be administered to children, and to this end there is Food and Drug Administration (FDA) regulatory guidance. This is a randomised, single-blind (run-in period)/double-blind (treatment period), parallel group, placebo controlled, multicentre study to assess the effect of once daily (OD) inhaled fluticasone furoate (FF) 50 microgram (mcg) on growth velocity in prepubertal asthmatic children on a background therapy of open-label montelukast. This study will be conducted over a total duration of approximately 76 weeks: 16-week run-in period (single-blind placebo inhaler), 52-week double-blind treatment period (inhaled FF 50 mcg /placebo administered OD in the morning for 52 weeks) and 8-week follow-up period. The purpose of the study is to evaluate the magnitude of effect (with a level of precision) on growth velocity of prepubertal asthmatic paediatric subjects (aged 5 to \<9 years) following administration of OD inhaled FF 50 mcg for one year. This study fulfills European Union (EU) and United States (US) regulatory requirements for the evaluation of potential growth suppression in children.
Study identification
- NCT ID
- NCT02889809
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 477 participants
Conditions and interventions
Conditions
Interventions
- Fluticasone furoate Drug
- Placebo Drug
- Montelukast Drug
- Short Acting Beta 2 Agonist Drug
Drug
Eligibility (public fields only)
- Age range
- 5 Years to 9 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
- Jul 9, 2017
- Primary completion
- Apr 8, 2021
- Completion
- Jun 3, 2021
- Last update posted
- Jan 16, 2024
2017 – 2021
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arkansas | 72205 | — |
| GSK Investigational Site | Huntington Beach | California | 92648 | — |
| GSK Investigational Site | Homestead | Florida | 33030 | — |
| GSK Investigational Site | Loxahatchee Groves | Florida | 33470 | — |
| GSK Investigational Site | Miami | Florida | 33134 | — |
| GSK Investigational Site | Miami | Florida | 33135 | — |
| GSK Investigational Site | Miami | Florida | 33142 | — |
| GSK Investigational Site | Miami | Florida | 33175 | — |
| GSK Investigational Site | St. Petersburg | Florida | 33710 | — |
| GSK Investigational Site | Gainesville | Georgia | 30501 | — |
| GSK Investigational Site | Ypsilanti | Michigan | 48197 | — |
| GSK Investigational Site | Bellevue | Nebraska | 68123 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | — |
| GSK Investigational Site | Orangeburg | South Carolina | 29118-2040 | — |
| GSK Investigational Site | San Antonio | Texas | 78230 | — |
| GSK Investigational Site | Waco | Texas | 76712 | — |
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 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02889809, 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 16, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02889809 live on ClinicalTrials.gov.