Evidence Table 3Placebo-controlled trials in children with SAR

Author
Year
Country
Trial Name
Study design
Setting
Eligibility criteriaInterventionsRun-in/Washout PeriodAllowed other medications/interventionsMethod of outcome assessment and timing of assessmentAge
Gender
Ethnicity
Other population characteristicsNumber screened/eligible/enrolledNumber withdrawn/lost to fu/analyzedOutcomesMethod of adverse effects assessmentAdverse effects reportedTotal withdrawals; withdrawals due to adverse events
Kobayashi
1989
Randomized, double-blind, placebo-controlled, parallel MulticenterChildren aged 5–13 years, with seasonal allergic rhinitis
Exclusion: Use of systemic corticosteroids, beginning hyposensitization treatment, underlying nasal pathology, history of adverse reactions to inhaled or systematic corticosteroids, concurrent viral infection
beclomethasone dipropionate aqueous nasal spray, 42mcg twice daily vs placebo
Study duration: 3 weeks
Decongestants 24 hours before studyRescue medication: chlorheniramine maleate 4mgEvaluated at clinic on study days 4, 8, 15 for nasal and ocular symptoms, Cochron-matel-Haennszel Test, patient daily diary of symptomsMean age: 8.8 years
58.4% Male
88.1% Caucasian, 11.8% Other
Mean duration of present episode: BDP-AQ: 9.0 vs placebo: 3.4
No. of seasonal recurrences to date: BDP-AQ: 5.2 vs placebo: 5.3
Previous hyposensitization therapy: BDP: 30 vs placebo: 29
NR/NR/1010/0/101Physician’s overall evaluation:
 Greater improvement with BDP-AQ vs placebo: (p=.012)

Improvement at 15 days vs placebo:
 Nasal obstruction: p= .002
 Periocular swelling: p= .007
Patient self-reportAdverse events reported:
Bloody nose: BDP: 1 vs placebo: 0
Burning or stinging in nose:
BDP: 3 vs placebo: 4
Dizziness: BDP: 1 vs placebo: 0
Drowsiness: BDP: 1 vs placebo: 0
Eye pain: BDP: 0 vs placebo: 1
Headache: BDP: 3 vs placebo: 3
0;0
Strem 1978Randomized, double-blind, placebo-controlledChildren aged 6–15 years with seasonal allergic rhinitisflunisolide nasal spray, 50mcg three times daily vs placebo
Study duration: 4 weeks
NR/NRNRPatient daily diaryMean age: 10.5 years
70.8% Male
Ethnicity NR
NRNR/NR/480/0/48Days when symptoms were present >2 hours:
Baseline:
  Sneezing: F: 2.4 vs placebo: 2.5; p=0.89
   Stuffy nose: F: 8.0 vs placebo: 7.8; p=0.63
   Runny nose: F: 4.4 vs placebo: 3.8; p=0.69
   All symptoms combined: F: 9.0 vs placebo:
8.3; p=0.35
Patient self-reportAdverse events reported:
flunisolide:
  moderate: stomatitis, headache, cough, nosebleed, cough
  mild: sore throat, cough
 placebo:
  moderate: sore throat, nausea, cheilosis
  mild: nosebleed, sore throat, nasal stuffiness
0;0
Gale 1980Randomized, double-blind, placebo-controlled, parallel Single-centerChildren aged 5–14 years with seasonal allergic rhinitisflunisolide 50mcg four times daily vs placebo
Study duration: 6 weeks
NR/NRNRPatient daily diaryMean age: 9.7 years
74.2% Male
Ethnicity NR
NRNR/NR/35NR/NR/NRPercentage of patients reported total or substantial control of hay fever symptoms:
 F: 64% vs placebo: 33%; P<0.05

Improvement of symptoms at 4 weeks: P-values of flunisolide vs placebo:
 Sneezing: NS
 Stuffy nose: p< 0.05
 Runny nose: p< 0.05
Patient self-reportNumber of adverse events reported:
 At 2 weeks: F: 14 vs placebo: 14
 At 4 weeks: F: 6 vs placebo: 9
NR;0
Munk, 1994Randomized, double-blind, placebo-controlled, parallel Multi-centerChildren aged 12–17 years with seasonal allergic rhinitis, naive to intranasal fluticasone propionate, and/or failed therapy with other medicationsIntranasal fluticasone propionate 200mcg once daily vs 100mcg twice daily vs placebo
Study duration: 2 weeks
NR/NRchlorpheniramine maleateClinician and patient symptom scoresMean age: 14.1 years
93% Male
Ethnicity NR
NRNR/NR/2433/NR/NRMean rhinitis symptom scores at 15 days:
 Nasal obstruction: clinician-rated:
  F100: 39.5 vs F200: 40.8 vs placebo: 54.1
 Nasal obstruction: patient-rated:
  F100: 33.4 vs F200: 38.5 vs placebo: 52.7
Patient self-reportAdverse events reported:
 Any event: F100: 5 vs F200:
13 vs placebo: 9
 Nasal burning: F100: 1 vs F200: 1 vs placebo: 1
 Epistaxis: F100: 1 vs F200: 3 vs placebo: 1
 Sneezing: F100: 0 vs F200: 1 vs placebo: 3
Urticaria: F100: 1 vs F200: 1 vs placebo: 1
NR;3
Boner 1995Double-blind, placebo-controlled, parallel multi-centerChildren with seasonal allergic rhinitis for at least one season
Exclusion: perennial arthritis, immunotherapy treatment, use of intranasal, inhaled systemic corticosteroids, inhaled, intranasal sodium cromoglycate or neocromil sodium within one month before study
fluticasone propionate aqueous nasal spray 100mcg vs 200mcg vs placebo
Study duration: 4 weeks
NR/NRNRPhysical examination, symptoms assessmentMean age: 8.3 years
Male: 72.6%
Ethnicity NR
NRNR/NR/143NR/NR/NRMedian percentage of symptoms-free days: p-value of treatment vs placebo:
F100:
 Sneezing: p=0.016
 Rhinorrhoea: p=0.011
 Nasal blockage on waking: p=0.011
 Nasal blockage during day: p=0.031
F200:
 Sneezing: p=0.018
 Rhinorrhoea: p=0.042
Patient self-reportNo. of adverse events: F100:
30 vs F200: 16 vs placebo: 40
No. of patients with adverse events: F100: 20 vs F200: 13 vs placebo: 23
No.of patients with serious adverse events: F100: 1 vs F200: 0 vs placebo: 0
No.of patients withdrawn due to adverse events
NR;2
Schenkel 1997Randomized, double-blind, placebo-controlled MulticenterChildren aged 6–11 years with spring grass seasonal allergic rhinitistriamcinolone acetonide aqueous nasal inhaler, 110mcg daily vs 220mcg daily vs placebo
Study duration: 2 weeks
NR/NRNRPatient daily diary, 4 clinical visits within 2 week period including physical examinationMean age: 9 years
Male: 65.9%
Caucasian: 87%
NRNR/NR/223NR/NR/204Mean changes in symptom scores at 2 weeks
 Nasal Stuffiness: TA110: +0.16 vs TA220: +0.15 vs placebo: +0.15
 Nasal Discharge: TA110: +0.15 vs TA220: +0.19 vs placebo: +0.15
 Sneezing: TA110: +0.09 vs TA220: +0.22 vs placebo: +0.06
Patient self-reportPercentage of reported adverse events: TA110:
16.2% vs TA220: 23.3% vs placebo: 18.4%
Headache reported:
TA110: 7% vs TA220: 3% vs placebo: 4%
Epistaxis reported:
TA110: 1% vs TA220: NR vs placebo: 4%
NR;0
Banov, 1996Randomized, double-blind, placebo-controlled, parallel MulticenterChildren aged 6–11 years, with seasonal allergic rhinitis
Exclusion: Any clinically relevant deviation from medical lab tests, history of hypersensitivity to corticosteroids, treatment with nasal, inhaled or systemic corticosteroids within 42 days of study
triamcinolone acetonide aerosol nasal inhaler, 220mcg daily, vs placebo
Study duration: 2 weeks
NR/NRNRPatient diary symptom scoresMean age: 9 years
Male: 63.7%
Caucasian: 93%,
African-American: 7%
NRNR/NR/1161/0/115Symptom scores at 1 and 2 weeks:
 Nasal stuffiness:
   Week 1: TAA: −0.60 vs placebo: −0.33
   Week 2: TAA: −0.91 vs placebo: −0.37
 Nasal discharge:
   Week 1: TAA: −0.67 vs placebo: −0.38
   Week 2: TAA: −1.02 vs placebo: −0.46
Patient self-reportAdverse events reported:
TAA: 31
placebo: 22
1;0
Galant, 1994Randomized, double-blind, placebo-controlled, parallel MulticenterChildren aged 4–11 years, with history of seasonal allergic rhinitis, severe symptoms, and positive skin test reaction to a local autumn allerginintranasal fluticasone propionate, 100mcg or 200mcg, once daily vs placebo
Study duration: 4 weeks
NR/NRNRPatient diary, analog scalesMean age: 8 years
Male: 64.3%
Ethnicity NR
NRNR/NR/2497/0/242Clinician-rated overall response:
 Better response with both F100 and F200 vs placebo: (p<0.01)
 Significant improvement:
   F100: 29% vs F200: 35% vs placebo: 11%
Patient self-reportAdverse events reported:
 Any event: F100: 4% vs F200: 13% vs placebo: 7%
 Crusting in nostril: F100: 2% vs F200: 0% vs placebo: 0%
 Nasal blockage: F100: 0% vs F200: 2% vs placebo: 0%
 Nasal burning: F100: 0% vs F200: 4% vs placebo: 2%
7;4
Grossman 1993Randomized, double-blind, placebo-controlled, parallel MulticenterChildren aged 4–11 years, with seasonal allergic rhinitis, positive skin test reaction to late- summer, autumn allergin, moderate to severe nasal symptomsfluticasone propionate aqueous nasal spray, 100mcg vs 200mcg once daily vs placebo Study duration: 2 weeksNR/NRchlorpheniramine maleateNasal and ocular symptoms assessed on days 1, 8, 15, 22Mean age: 8.8 years
Male: 65.3%
Ethnicity NR
Positive skin test, %
 Any fall allergin: 100%
 Weed: 92%
 Grass: 7.6%
Mold: 11.3%
History of asthma: 44.6%
NR/NR/250NR/NR/NRClinician-rated mean symptom scores at 22 days:
 Rhinorrhea: F100: 43 vs F200: 46 vs placebo: 48
 Sneezing: F100: 22 vs F200: 22 vs placebo: 21
 Nasal itching: F100: 33 vs F200: 39 vs placebo: 37
Ocular symptoms: F100: 22 vs F200: 29 vs placebo: 26
Patient self-reportAdverse events reported:
 Any event: F100: 12% vs F200: 5% vs placebo: 8%
 Nasal burning: F100: 4% vs F200: 1% vs placebo: 0%
 Epistaxis: F100: 4% vs F200: 2% vs placebo: 4%
Headache: F100: 0% vs F200: 1% vs placebo: 2%
NR;NR

From: Evidence Tables

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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