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NCT01154153 · ClinicalTrials.gov registry record · Phase 4
Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis
A Phase 4 study of Rhinitis, Allergic, Perennial and/or Seasonal, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 140
- Enrollment target
- 8
- Study locations
NCT01154153: Completed Phase 4 study of Rhinitis, Allergic, Perennial and/or Seasonal, sponsored by Sanofi.
NCT01154153 is a Phase 4 study of Rhinitis, Allergic, Perennial and/or Seasonal that has completed, run by Sanofi. The registered enrollment target is 140 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01154153, a Phase 4 study of Rhinitis, Allergic, Perennial and/or Seasonal, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 140 participants
- Enrollment target
- 8
- Study locations
Study Summary
The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg) and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA) axis function as measured by serum cortisol AUC(0-24 hr) in children (\>=2 to \<12 years old) with allergic rhinitis (AR).
Primary Outcome
Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times. Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC\[0-24 hr\] at 6 weeks postrandomization)/(Serum Cort
Conditions Studied
Interventions
- DRUG Placebo nasal spray
- DRUG Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ)
- DRUG Claritin® Syrup
Study Locations (8)
California
- Investigational Site Number 840003 - Cypress
Georgia
- Investigational Site Number 840006 - Stockbridge
Massachusetts
- Investigational Site Number 840007 - North Dartmouth
Minnesota
- Investigational Site Number 840010 - Plymouth
Nebraska
- Investigational Site Number 840001 - Omaha
North Carolina
- Investigational Site Number 840008 - Raleigh
South Carolina
- Investigational Site Number 840002 - Spartanburg
Texas
- Investigational Site Number 840005 - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2010-06 |
| Est. Completion | 2010-10 |
| Phase | Phase 4 |
What the finished NCT01154153 record still lists
NCT01154153 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Rhinitis, Allergic, Perennial and/or Seasonal appearing as the primary indexed condition, and to 3 interventions - of which Placebo nasal spray is the first listed.
NCT01154153 lists 8 locations in 8 states (California, Georgia, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT01154153 about?
NCT01154153 is a clinical study titled "Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis". The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg) and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA) axis function as measured by serum cortisol AUC(0-24 hr) in children (\>=2 to \<12 years old) with allergic rhinitis ...
What is the current status of trial NCT01154153?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2010-06. Estimated completion is 2010-10.
What conditions does trial NCT01154153 study?
This clinical trial studies the following conditions: Rhinitis, Allergic, Perennial and/or Seasonal.
What interventions are being tested in trial NCT01154153?
The interventions under investigation include: Placebo nasal spray (DRUG), Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ) (DRUG), Claritin® Syrup (DRUG).
Who is sponsoring clinical trial NCT01154153?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01154153 being conducted?
This trial has 8 study locations across California, Georgia, Massachusetts, Minnesota, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01154153's enrollment target sits among peer trials
140 581st of 2000 higher than 1,408 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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