Clinical evaluation of triamcinolone acetonide nasal aerosol in children with perennial allergic rhinitis.
Triamcinolone acetonide aerosol (TAA), a topical corticosteroid, now available for intranasal use, has been shown to be highly effective in the treatment of both seasonal and perennial allergic rhinitis (PAR) in adults. To evaluate the efficacy and safety of TAA in children, 210 patients (ages 4 to 12 years) with PAR were randomly assigned to one of three treatment groups (placebo, TAA 82.5 micrograms/day, or TAA 165 micrograms/day). Medication was given tid over 12 weeks in a double-blind fashion. Response to medication was evaluated using symptom scoring, physician evaluation, and, in 44 patients, nasal airflow determinations by anterior rhinomanometry. The higher dose of TAA (165 micrograms/day) significantly improved rhinitis symptoms relative to placebo: the total nasal symptom score and most individual symptom scores (eg, nasal stuffiness, itch, sneezing) were significantly better, duration of rhinitis symptoms (hours per day) was significantly reduced, and nasal airflow in a subset of patients showed significant improvement. The lower dose of TAA (82.5 micrograms/day) was superior to placebo by the same parameters as the higher dose, but this improvement was not as consistently significant as the higher dose. There were no clinically significant adverse events; nasal irritation and epistaxis were rare with a similar incidence among treatment groups. In conclusion, TAA at 165 micrograms/day was effective in controlling the symptoms of PAR and in improving nasal airflow in pediatric patients; the lower dose (82.5 micrograms/day) was marginally effective. Both doses were safe and well-tolerated in the children studied.
Welch
M J
MJ
Bronsky
E A
EA
Grossman
J
J
Shapiro
G G
GG
Tinkelman
D G
DG
Garcia
J D
JD
Gillen
M S
MS
D000280:Administration, Inhalation; D000336:Aerosols; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D014222:Triamcinolone Acetonide / Q000008:administration & dosage*
D000336:Aerosols; D014222:Triamcinolone Acetonide