Last updated: 11/07/2018 17:09:54
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Potential Effects of a Six-Week Course of Fluticasone Propionate Aqueous Nasal Spray (200mcg QD) on the HPA-Axis in 2 and <4 Year Old Subjects with Allergic Rhinitis.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Potential Effects of a Six-Week Course of Fluticasone Propionate Aqueous Nasal Spray (200mcg QD) on the HPA-Axis in 2 and <4 Year Old Subjects with Allergic Rhinitis.
Trial description: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Potential Effects of a Six-Week Course of Fluticasone Propionate Aqueous Nasal Spray (200mcg QD) on the HPA-Axis in 2 and <4 Year Old Subjects with Allergic Rhinitis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: No hpa axis effect in 2 and 3 year-old allergic rhinitis patients treated with fluticasone propionate aqueous nasal spray. Philpot, E E, Nayak, A S, Melamed, I R, Prillaman, B A, Cook, C R, Reed, K D, and Rickard, K A 98th International Conference of the American Thoracic Society 5/17/2002 Atlanta, GA; USA
Galant SP, Melamed IR, Nayak AS, Blake KV, Prillaman BA, Reed KD, Cook CK, Philpot EE, Rickard KA. Lack of effect of fluticasone propionate aqueous nasal spray on the hypothalamic-pituitary-adrenal axis in 2- and 3-year-old patients. Pediatrics 2003;112(1):96-100.
Philpot EE, Nayak AS, Melamed IR, Prillaman BA, Cook CK, Reed KD, Rickard KA. No HPA axis effects in 2 and 3 year –old allergic rhinitis patients treated with fluticasone propionate aqueous nasal spray. Am J Respir Crit Care Med 2002;165(8): B39 (abstract)
Medical condition
Rhinitis
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
March 2000 to October 2000
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2000-25-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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