Evidence Table 13Placebo-controlled trials of harms outcomes

Author
Year
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Other population characteristicsNumber screened/eligible/enrolledNumber withdrawn/lost to fu/analyzedOutcomesMethod of adverse effects assessmentAdverse effects reportedTotal withdrawals; withdrawals due to adverse eventsComments
Schenkel
2000
Randomized, double-blind, placebo-controlled multicenterChildren with perennial allergic arthritis no greater than stage 1 on the Tanner Classification of Sexual Maturity, height between 5th–95th percentile
Exclusion criteria: asthma requiring chronic use of inhaled corticosteroids for asthma for >2 months, history/presence of abnormal growth or malnutrition, history of multiple drug allergies, allergy to corticosteroids, posterior subcapsular cataracts or nasal structural abnormailites, upper respiriatory infection, sinus infection within 1 week before study
mometasone furoate aqueous nasal spray (MFNS), 100 mean grams once daily vs placebo
Study period: 12 months
NR/NRTreatment with immunotherapy if patient on a stable schedule for at least 1 month before screening, 1–2 courses oral prenisone lasting no > 7 days, oral corticosteroids, low-potency dermatologic corticosteroids, nonsteroidal allergy preparationsCosyntropin stimulation testing performed in half of centers at 6 and 12 months, vital signs taken at each visit, clinical lab determinations taken at baseline, week 26 and endpoint, height measured at 4, 8, 12, 26, 39 and 52 weeks6.3 years
67.3% Male
Ethnicity NR
Asthma: MFNS: 32.6% vs placebo: 26.5%
Comorbid SAR: MFNS: 79.5% vs placebo: 73.4%
Mean body weight: MFNS: 54.5 vs placebo: 55.2
Mean height: MFNS: 120.2cm vs placebo: 120.9cm
NR/NR/9814/16/82Mean Increase in Height after 12 months of treatment:
Age 3–5y: MFNS: 7.65 cm vs placebo: 7.26 cm
Age 6–9y: MFNS: 6.67 cm vs placebo: 6.0cm
Female: MFNS: 6.73cm vs placebo: 6.25 cm
Male: 7.07cm vs placebo: 6.39cm
Patient self-reportNumber of patients reporting adverse events
Epistaxis: MFNS 12% vs placebo: 8%
Nasal irritation: MFNS: 8% vs placebo: 6%
Headache: MFNS: 0 vs placebo: 2%
Pharyngitis: MFNS: 0 vs placebo: 2%
Rhinitis: MFNS: 0 vs placebo: 2%
Sneezing: MFNS: 0 vs placebo: 0
Withdrawals (16): MFNS: 7 vs placebo 9;
  Withdrawal due to adverse event (2): MFNS: 1 vs placebo: 1
Skoner
2000
Randomized, double-blind, twice daily dose, placebo-controlled, parallelPrepuertal children, aged 6–9 years with perennial allergic rhinitis, baseline heights between 5th–95th percentile, skeletal age within 2 years of chronological ageintranasal beclomethasone dipropionate 168mcg vs placebo
Study period: 1 year
NR/NRNR/NRHeight measured with stadiometer at 1,2, 4,6, 8, 10 and 12 monthsNRNRNR/NR/100NR/NR/80Mean standing height at 1 year:
BDP: 5.0cm vs placebo: 5.9 cm
NRNo unusual adverse events observedNR; NR
Allen, 2002Randomized, double-blind, placebo-controlledChildren with perennial arthritis found from positive skin test, nasal symptoms at least once daily in past year, normal current growth within 5–95 percentile, normal height growth reflected in at least two height measurements, Tanner Sexual maturity rating of 1 for all classifications. Exclusion: conditions that could require concomitant corticosteroid therapy, use of inhaled, intransal, oral, optical or injectable corticosteroids, or >1% subcutaneous hydrocortisone with 1 month of study, evidence of malnutritionfluticasone propionate aqueous nasal spray, 200mcg daily vs placebo
Study period: 1 year
NR/NRNRGrowth, measured by stadiometry every 30 days at clinical visit6 years
34% Female
White: 80%, Black: 11%, Asian: 2%, Hispanic: 4.5%, Other: 2%
NRNR/NR/15040/12/110Mean Height Measurements: vs baseline
With at least 3 months of treatment data:
 F: 119.0cm vs placebo: 119.0cm
At one year of treatment:
 F: 125.5cm vs placebo: 125.4cm
Patient outcome, self-reportReport of Adverse Events:
 Any event: F: 12% vs placebo: 12%
 Epistaxis: F: 9% vs placebo: 8%
 Nasal irritation: F: 3% vs placebo: 0%
 Headache: F: 1% s placebo: 1%
 Gastric upset: F: 0% vs placebo: 1%
 Nasal burning: F: 0% vs placebo: 1%
 Nasal soreness: F: 1% vs placebo: 0%
 Vestibulitis of nose: F: 0% vs placebo: 1%
40;9
Holm
1998
Randomized, double-blind, placebo-controlled, parallel
Single-center
Patients with perennial allergic rhinitis for at least 1 year.
Exclusion: serious/unstable disease, infection of upper/lower respiratory tract, structural abnormalities, nasal surgery >6 months before study, concurrent use of oral/inhaled steroids, intrana
intranasal fluticasone propionate aqueous, 100mcg twice daily vs placebo
Study period: 1 year
4 weeks/NRterfenadine tablets, 60mg as rescue medication12 clinic visits conducted between 4–6 weeks, nasal blockage, nasal discharge, sneezing, nasal itching, eye irritation assessed by daily diary cards completed for 10 days before clinic visits and investigator at clinical visits28 years
66.6% Male
Ethnicity NR
NRNR/NR/42NR/NR/29Percentage of patients with symptoms:
Baseline vs 1 year: FPANS
 Mucosal swelling: 23% vs 11%
 Evidence of crusting: 8% vs 14%
 Evidence of bleeding: 0% vs 5%
 Nasal polyps: 0% vs 0%
Baseline vs 1 year: placebo
 Mucosal swelling: 62% vs 37%
 Evidence of
Patient outcome, self-reportNo major adverse events reported
Minor adverse events reported:
Total: FPANS: (13)62% vs placebo (12)57%
FPANS:
 Headache: 5
 Bronchitis: 3
 Epistaxis: 3
 Upper respiratory tract infection: 3
 Mental depression: 1
NR; 1
Cutler
2006
Randomized, double- blind, placebo-controlled, parallel
Single-center
Children age ≥ 2 to <6 yrs with diagnosis of allergic rhinitis in good health (based on medical history, physical exam, ECG and routine lab tests)mometasone furoate (MFNS)
100μg/day
placebo
Study period: 6 wks
NR/NRNRSerum cortisol concentration and urinary free cortisol lels at day 42 (primary endpoint)
AEs spontaneously reported
4.0 years
59% male
39.3% Caucasian
55.4% Black
5.3% Othe
Mean height 101 cm
Mean weight 18.0 kg
NR/NR/564/0/56NRPatient self-reportAdverse events: MMNS vs placebo
Headache: 2/28 (7%) vs 3/28 (11%)
Rhinorrhea: 2/28 (7%) vs 3/28 (11%)
Abdominal pain: 0/28 vs 2/28 (7%)
Irritability: 1/28 (4%) vs 1/28 (4%)
URTI: 2/28 (7%) vs 0/28
Ecchymoses: 0/28 vs 1/28 (4%)
Skin trauma: 1/28 (4%) vs 0
4; 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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