Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma
Public ClinicalTrials.gov record NCT02483975. 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 Randomized, Double-blind, Placebo-controlled, Parallel Group Study of Once-daily Inhaled Fluticasone Furoate Inhalation Powder for Six Weeks on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02483975
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 111 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
- Oct 9, 2015 (Actual)
- Primary completion
- Jun 20, 2016 (Actual)
- Completion
- Jun 21, 2016 (Actual)
- Last update posted
- Apr 27, 2020
2015 – 2016
United States locations
- U.S. sites
- 14
- U.S. states
- 7
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arkansas | 72211 | — |
| GSK Investigational Site | Alhambra | California | 91801 | — |
| GSK Investigational Site | Costa Mesa | California | 92626 | — |
| GSK Investigational Site | Huntington Beach | California | 92647 | — |
| GSK Investigational Site | Newport Beach | California | 92663 | — |
| GSK Investigational Site | Homestead | Florida | 33030 | — |
| GSK Investigational Site | Miami | Florida | 33135 | — |
| GSK Investigational Site | Miami | Florida | 33142 | — |
| GSK Investigational Site | Miami | Florida | 33175 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | — |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | — |
| GSK Investigational Site | Houston | Texas | 77055 | — |
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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02483975, 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 Apr 27, 2020 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02483975 live on ClinicalTrials.gov.