Table 13

Placebo-controlled trials in children/adolescents with perennial allergic rhinitis

Study
Sample size
Interventions (Total daily dose) DurationMean age Age range % femaleOutcomeResults
Day, 1990
N=51
Budesonide BID (200 mcg)
Placebo
4 weeks
13.4 compared with 13.3 years, 7–18 compared with 6–18 years
53.4% compared with 40%
Difference in combined nasal symptom scores, including sneezing, blocked nose, itchy nose, runny nose−0.95 ± 1.87 compared with −0.37 ± 1.38
P < 0.05
Fokkens, 2002
N=202
Budesonide aqueous QD (128 mcg)
Placebo
6 weeks
10.5 compared with 10.7 years, 6–16 years, 34.3%Difference in combined nasal symptom scores (evening), including sneezing, blocked nose, runny nose−1.86 compared with −0.93; P<0.001
Hill, 1978
N=22
Beclomethasone aerosol QD (300 mcg)
Placebo
6 weeks then crossover
NR, 7–17
years, 50%
% children with improved nasal symptoms (lower mean daily diary score)86.4%
P<0.01 placebo results not reported
Shore, 1977
N=46
Beclomethasone aerosol (300 mcg)
Placebo
3 weeks then crossover, followed by 3 months open label with active drug (200 mcg)
8 years, 4–12
years, 21.7%
Patient assessment that drug was effective75%
placebo results not reported
Neuman, 1978
N=30
Beclomethasone aerosol 4 times daily (200 mcg)
Placebo
3 weeks then crossover
13.8 years, 9–18 years, 53.3%Difference (baseline to end of study) in average daily symptom score on 4-point scaleGroup I −2.5 compared with 0
Group II −2.5 compared with +2.65 (no washout period)
Ngamphaiboon, 1997
N=106
Fluticasone p. aqueous QD (100 mcg)
Placebo
4 weeks
8.96 compared with 9.06 years, 5–11 years, 18.9% compared with 10.3%Physician-rated mean total symptom score (sum of obstruction, rhinorrhea, sneezing and itching, scale 0–3)−6.13 compared with −5.7, P<0.05
Todd, 1983
N=64
Flunisolide aqueous QD (150 mcg)
Placebo
4 weeks then crossover
8.3 years, 3–17 years, 39%Mean daily total symptom score (stuffy nose, sneezing, runny nose, nose blowing, and eye symptoms)Significantly lower than placebo for Group II only for 11 of 28 days
Sarsfield, 1979
N=27
Flunisolide aqueous QD (150 mcg)
Placebo
2 months then crossover
12.3 years, 7–16 years, 22%Mean weekly symptom scores on 4-point scale
 (A) sneezing
 (B) stuffy nose
 (C) runny nose
 (D) nose-blowing
Week 4
 (A) 0.64 vs. 1.17
 (B) 1.04 vs. 1.00
 (C) 0.62 vs. 0.85
 (D) 1.10 vs. 1.45
Welch, 1991
N=210
Triamcinolone aerosol (165 mcg)
Triamcinolone aerosol (82.5 mcg)
Placebo
12 weeks
9 years, 4–12 years, 33%Adjusted mean change from baseline total nasal symptom score in first 6 weeks (no escape medication allowed) and second 6 weeks (escape medication allowed)Estimated from figure:
first 6 weeks
2.65 compared with
2.2 compared with
1.65
second 6 weeks
3.35 compared with
2.75 compared with
2.05
P<0.01 for highest dose compared to placebo
Storms, 1996
N=137
Triamcinolone aerosol (220 mcg)
Placebo
4 weeks
8.9 years, 6–11 years, 27% compared with 44%Adjusted mean change from baseline nasal index: sum of symptom scores for nasal stuffiness, nasal discharge, and sneezing each on a 4-point scale−2.27 compared with −1.36, P<0.05
Nayak, 1998
N=80
Triamcinolone aqueous (220 mcg)
Triamcinolone aqueous (440 mcg)
Placebo
6 weeks
9.5 years, 6–12 years, 37.5%Outcome not eligible, for adverse events only

From: Results

Cover of Drug Class Review: Nasal Corticosteroids
Drug Class Review: Nasal Corticosteroids: Final Report Update 1 [Internet].
Selover D, Dana T, Smith C, et al.
Portland (OR): Oregon Health & Science University; 2008 Jun.
Copyright © 2008, Oregon Health & Science University, Portland, Oregon.

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