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NCT02483975 · ClinicalTrials.gov registry record · Phase 3
Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 111
- Enrollment target
NCT02483975 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 111 participants.
The verdict
NCT02483975, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 111 participants
- Enrollment target
Study Summary
Inhaled corticosteroids (ICS) have a number of known class effects including hypothalamic-pituitary-adrenocortical (HPA) axis suppression. Although the safety of inhaled Fluticasone Furoate (FF) on the HPA axis of adults and adolescent asthmatic patients has been established, it is important to assess the risk of suppression in children so as to establish whether this medicine can be safely used in this young population. This study aims to evaluate the effect of inhaled FF on the HPA axis of children 5-11 years of age (inclusive) with persistent asthma compared with placebo. Approximately 143 subjects will be enrolled. Subjects will enter a 7 to 14 day run-in period on oral montelukast 4 milligrams (mg) (5 year old subjects) or 5 mg (6-11 year old subjects) once daily. Eligible subjects will be randomized to receive once-daily FF inhalation powder 50 micrograms (mcg) or once-daily placebo inhalation powder in the morning via the ELLIPTA™ inhaler for 42 days. Subjects will continue to receive open label montelukast during the treatment period. All subjects will be provided albuterol/salbutamol inhalation aerosol, to use as needed to treat acute asthma symptoms throughout the study. ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies.
Interventions
- DRUG Placebo
- DRUG Montelukast
- DRUG FF
- DRUG Albuterol/Salbutamol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2015-10-09 |
| Est. Completion | 2016-06-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02483975
The ClinicalTrials.gov registry entry for NCT02483975 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02483975 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02483975 about?
NCT02483975 is a clinical study titled "Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma". Inhaled corticosteroids (ICS) have a number of known class effects including hypothalamic-pituitary-adrenocortical (HPA) axis suppression. Although the safety of inhaled Fluticasone Furoate (FF) on the HPA axis of adults and adolescent asthmatic patients has been established, it is important to asse...
What is the current status of trial NCT02483975?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 111 participants. The study started on 2015-10-09. Estimated completion is 2016-06-21.
What interventions are being tested in trial NCT02483975?
The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG), FF (DRUG), Albuterol/Salbutamol (DRUG).
Who is sponsoring clinical trial NCT02483975?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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