Fluticasone Propionate Aqueous Nasal Spray Is Safe and Effective for Children With Seasonal Allergic Rhinitis
1 Allergy Care Consultants, Ltd, Tucson, AZ
2 Adult and Pediatric Allergy Center, Charleston, SC
3 Intermountain Allergy and Asthma Clinic, Salt Lake City, UT
4 Allergy Associates, Colorado Springs, CO
5 Colorado Allergy & Asthma Clinic, PA, Aurora, CO
6 Allergy and Asthma Research Center-Toledo, Sylvania, OH
7 Sylvana Research, San Antonio, TX
8 Pediatric and Adult Allergy, West Hartford, CT
9 HealthQuest Research, Austin, TX
10 Glaxo Research Institute, Research Triangle Park, NC.
Introduction. Fluticasone propionate aqueous nasal spray, a new topical corticosteroid preparation, is effective when given as 200 µg once daily in patients (> 12 years of age) with seasonal allergic rhinitis.
Study objective. To evaluate the efficacy and safety of fluticasone propionate aqueous nasal spray in children aged 4 to 11 years with seasonal allergic rhinitis.
Study design. Multicenter, randomized, double-blind, placebo-controlled, parallel-group.
Patients. Two hundred fifty children aged 4 to 11 years with moderate-to-severe nasal symptoms, a positive skin test reaction to a late-summer or autumn allergen, a history of seasonal allergic rhinitis, and documentation of an unsatisfactory response to conventional treatment.
Interventions. Children were randomly assigned to receive fluticasone propionate, either 100 µg or 200 µg, or placebo, given by intranasal spray once daily in the morning for 14 days.
Measurements and results. Severity of nasal symptoms (obstruction, rhinorrhea, itching, and sneezing) was recorded on visual analog scales by investigators at weekly visits and by patients (or adult guardian) daily in the evening. According to investigator and patient ratings, both fluticasone propionate 100 µg/d and 200 µg/d lowered total nasal symptom scores when compared with placebo. Both dosages of fluticasone propionate were more effective than placebo on the basis of investigatorrated overall clinical evaluation of efficacy at the end of treatment, with significant improvement (as opposed to moderate or mild improvement, no change or worsening) noted in 21% to 29% of the active-treatment groups vs 9% in the placebo group. There were no significant differences between the two fluticasone propionate dosages in any efficacy measurement. Morning plasma cortisol concentrations and frequency of drug-related adverse events were similar in the fluticasone propionate and placebo groups.
Conclusion. In children as young as 4 years, 100 µg of fluticasone propionate aqueous nasal spray given once daily is as effective as 200 µg given once daily, the usual adult dose for the treatment of seasonal allergic rhinitis. Both fluticasone propionate dosages were well tolerated and neither dosage appears to interfere with the hypothalamic-pituitary-adrenal axis in children.
Key Words: fluticasone propionate • seasonal allergic rhinitis • intranasal corticosteroid • compliance
Submitted on June 15, 1992
Accepted on April 15, 1993
This article has been cited by other articles:
 |
|
 |
|
  S. P. Galant, I. R. Melamed, A. S. Nayak, K. V. Blake, B. A. Prillaman, K. D. Reed, C. K. Cook, E. E. Philpot, and K. A. Rickard Lack of Effect of Fluticasone Propionate Aqueous Nasal Spray on the Hypothalamic-Pituitary-Adrenal Axis in 2- and 3-Year-Old Patients Pediatrics, July 1, 2003; 112(1): 96 - 100. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 M Silverman, M Wang, G Hunter, and N Taub Episodic viral wheeze in preschool children: effect of topical nasal corticosteroid prophylaxis Thorax, May 1, 2003; 58(5): 431 - 434. [Abstract] [Full Text] [PDF]
|
|
