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NCT02889809 · ClinicalTrials.gov registry record · Phase 4
Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 477
- Enrollment target
NCT02889809: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT02889809 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 477 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02889809, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 477 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Three reproducible height measurements were taken using a stadiometer at each visit and were recorded to nearest 1/10th of centimeter. Each set of triplicate measurements was averaged to derive one estimated height per participant per visit. Growth velocity was calculated for each participant over double-blind treatment period (up to 52 weeks \[wk\]) by fitting a regression line to averaged height measurements at each visit for that participant during period. Slope of this regression line was pa
Interventions
- DRUG Placebo
- DRUG Montelukast
- DRUG Fluticasone furoate
- DRUG Short Acting Beta 2 Agonist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 477 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2021-06-04 |
| Phase | Phase 4 |
What the finished NCT02889809 record still lists
NCT02889809 is an interventional study that assigns participants to a tested intervention. The registered 477 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02889809 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02889809 about?
NCT02889809 is a clinical study titled "Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year". 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 rando...
What is the current status of trial NCT02889809?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 477 participants. The study started on 2017-07-10. Estimated completion is 2021-06-04.
What interventions are being tested in trial NCT02889809?
The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG), Fluticasone furoate (DRUG), Short Acting Beta 2 Agonist (DRUG).
Who is sponsoring clinical trial NCT02889809?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02889809's enrollment target sits among peer trials
477 182nd of 2000 higher than 1,819 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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