Abstract | INTRODUCTION: STUDY OBJECTIVE: 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 micrograms or 200 micrograms, 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 micrograms/d and 200 micrograms/d lowered total nasal symptom scores when compared with placebo. Both dosages of fluticasone propionate were more effective than placebo on the basis of investigator-rated 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:
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Authors | J Grossman, C Banov, E A Bronsky, R A Nathan, D Pearlman, J A Winder, P H Ratner, L Mendelson, S R Findlay, K M Kral |
Journal | Pediatrics
(Pediatrics)
Vol. 92
Issue 4
Pg. 594-9
(Oct 1993)
ISSN: 0031-4005 [Print] United States |
PMID | 8414833
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Aerosols
- Androstadienes
- Anti-Inflammatory Agents
- Fluticasone
- Hydrocortisone
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Topics |
- Administration, Topical
- Aerosols
- Androstadienes
(administration & dosage, adverse effects, therapeutic use)
- Anti-Inflammatory Agents
(administration & dosage, adverse effects, therapeutic use)
- Child
- Child, Preschool
- Double-Blind Method
- Drug Administration Schedule
- Female
- Fluticasone
- Humans
- Hydrocortisone
(blood)
- Male
- Rhinitis, Allergic, Seasonal
(drug therapy)
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