Evidence Table 8Quality assessment of placebo-controlled trials in children with PAR

Internal ValidityExternal Validity
Author, Year, CountryRandomization adequate?Allocation concealment adequate?Groups similar at baseline?Eligibility criteria specified?Outcome assessors masked?Care provider masked?Patient masked?Reporting of attrition, crossovers, adherence, and contaminationLoss to follow-up: differential/highIntention-to- treat (ITT) analysisPost-randomization exclusionsQuality ratingNumber screened/eligible/enrolledExclusion criteriaRun-in/washoutClass naïve patients onlyControl group standard of careFundingRelevance
Day
1990
Method not reportedNRYesYesYesYesYesNo, No, Yes, NoNoYesNoFairNR/NR/107 adults and childrenPregnancy, tuberculosis, respiratory infection, additional nasal disease or asthma requiring treatment with corticosteroids2-week baseline period where patients recorded symptoms and received only terfenadine (60mg up to two tablets per dayNoN/AOne author is from AB Draco, Lund, SwedenYes
Fokkens
2002
Method not reportedNRSomeYesYesYesYesNo, No, No, NoNoYesNoFairNR/NR/202Polllen allergy in season, upper respiratory infection within 2wks before screening, rhinitis medicamentosa or structural abnormalities symptomatice enough to cause significant nasal obstruction, unstable asthma, immunotherapy not on constant maintenance dose, any other significant diseases, systemic corticosteroid therapy within 2 months, extensive application of topical cutaneous steroids, topical nasal steroids within one month before screening, other medication possibly interfering: antihistamines within 3 days, cromoglycate within 2 wks, astemizole within 1 month before screening1-week baseline period in which efficacy variables were measured twice dailyNoN/AFinancial support from AstraZeneca R&D, Lund SwedenYes
Hill
1978
Method not reportedNRNRYesYesYesYesNo, Yes, No, NoNoYesNoFairNR/NR/22None reportedNoNoN/ANRYes
Nayak
1998
USA
NRyesyesyesyesNRyesyes, no, yes, nonoyesnofairNR/NR/80Any clinically relevant deviation from normal medical or laboratory parameters, an intolerance to corticosteroid therapy, any medical condition capable of althering the pharmacokintics of the drup, acute infetiors sinusitis, underlying nasal pathology resulting in occlusion of a nostril, visible evidence of fungal infectionn of the nose, throat, or mouth, or an initial morning plasma cortisol level outside the range of 5 to 20 mcg/dl.
Also patients treated with systemic corticosteroids within 90d, oral corticosteroids for more than 10d within the past year, or if they participated in any investigational drug study within 60d or any previous study with triamcinolone aquesous nasal spray.
nonoyesSupported in part by Rhone-Poulenc rore Pharaceuticals, Inc.yes
Neuman
1978
Israel
NRNRNRyesyesNRyesyes, yes, no, nononot clearnopoorNR/NR/30NRnonoyesNRyes
Ngamphaiboon
1997
Method not reportedNRYesYesYesNRYesNo, No, Yes, NoNoYesNoFairNR/NR/106Physical obstruction in the nose, concurrent diseases that would affect their ability to participate safely and fully in the study, hypersensitivity to any corticosteroid, use of any steroid, sodium cromoglycate or nedocromil sodium 2 weeks before enrollment, oral astemizole 6 weeks before the study, hyposensitization treatment during the previous 12 months, or concurrent infection of paranasal sinuses or upper or lower respiratory tract.NoNoN/AFinancial support from Glaxo ThailandYes
Sarsfield
1979
UK
NRNRNRNRyesNRyesYes, yes, no, nonoyesnofair to poorNR/NR/27NRNot reportednoyesNRyes
Shore
1977
Method not reportedNRNRYesYesYesYesYes, Yes, No, NoNoYesNoFairNR/NR/46None reported1-week washout between cross-overNoN/ANRYes
Storms
1996
Method not reportedNRnoyesyesyesyesyes, no, no, nonoyesnofairNR/NR/137Any clinical deviation from normal medical or lab parameters, nasal candiasis, acute sinusitis, or a history of hypersensitivity to corticosteroids
Any of the following conditions: treatment with nasal, inhaled or systemic corticosteroids within 42 days prior to the study, nasal cromolyn sodium within 14d, medication that might produce or relieve symptoms of allergic rhinitis, or an investigational drug within 90d, initiation of immunotherapy within 30d or participation in any previous
Triamcinolone trials.
nonoN/Afunded by Rhone- Poulenc Rorer Pharmaceuticalsyes
Todd
1983
Method not reportedNRNRyesyesyesyesNo, yes, no, nononoNofairNR/NR/64None reportedNoNoN/AMaterials supplied by Syntex Pharmaceuticals Ltd.yes
Welch
1991
Method not reportedNRyesyesyesyesyesno, no, no, nononoNRfairNR/NR/210Use of oral or parenteral corticosteroids within 60d prior to study, or long-acting depot steroids within 6 months, use of nasal corticosteroids or nasal cromolyn within 30d of the study, any evidence of infection, sinusitis, otitis media, nasal polyps or any fixed anatomical abnormality and lack of stabilization with immunotherapyBaseline period of 6–10d, no rhinitis medication was allowed during the last 5dnoN/ASupported by a grant from Rhone-Poulenc Rorer Pharmaceuticalsyes

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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