Pediatric Adenoidal Hypertrophy and Nasal Airway Obstruction: Reduction With Aqueous Nasal Beclomethasone
1 Department of Allergy and Immunology, 56th Medical Group, MacDill Air Force Base, FL 33621
2 Allergy-Immunology Department, Wilford Hall Medical Center, Lackland Air Force Base, Lackland, TX
Objective. Pediatric adenoidal obstruction of the nasal airway is associated with significant morbidity and is a frequent indication for surgery. Because efficacious medical alternatives to adenoidectomy are lacking, we assessed the potency of standard-dose topical nasal beclomethasone in reduction of adenoidal obstruction of the nasal airway.
Methods. Seventeen children, 5 to 11 years of age, exhibiting chronic obstructive nasal symptoms and a group mean (±SE) adenoid/choana ratio of 91 ± 1% on rhinoscopic examination, completed an 8-week, double-blind, placebo-controlled crossover study of standard- dose aqueous nasal beclomethasone (total 336 µg/day) in the treatment of adenoidal hypertrophy. In a 16-week, open-label, follow-on study, subjects received beclomethasone 1 spray in each nostril twice daily (168 µg/day).
Results. Over the initial 4 weeks, improvements in the mean adenoidal obstruction of the choanae were significantly greater in the group receiving beclomethasone than in the group receiving placebo (right, -14.0% vs. + 0.4%, P = .0002) (left, -15.0% vs. -2.0%, P = .0006). In the subsequent crossover 4 weeks, a significant beclomethasone carryover effect resulted in further adenoid size reduction in both treatment groups. All patients demonstrated a decrease in adenoid size with beclomethasone treatment, compared with a mixed response to placebo. Over the full 8-week crossover study, the mean (±SE) obstructive symptom score after beclomethasone treatment (20.5 ± 3.0) was significantly improved compared to patients' initial (43.1 ± 2.9) and placebo scores (31.1 ± 4.2, P
.05), despite the active drug carryover effect into the placebo treatment period. Significant improvements in adenoidal obstruction and symptom scores over the 8-week crossover study were enhanced in the subsequent 16-week open-label period (P = .0001). By 24 weeks, an 82% reduction in group mean nasal obstruction symptom score accompanied a 29% mean reduction in adenoid/choana ratio. No clinical or demographic characteristic predicted a patient's degree of response to treatment.
Conclusions. Properly administered aqueous nasal beclomethasone in standard doses can significantly reduce adenoidal hypertrophy and nasal airway obstructive symptoms in children.
Submitted on June 29, 1994Accepted on July 7, 1994
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