xRead - September 2022

Wise et al.

Page 373

Author Manuscript Author Manuscript Author Manuscript Author Manuscript TABLE IX.B.2.c-1. Evidence for the clinical efficacy of intranasal corticosteroids in the management of allergic rhinitis Study Year LOE Study design Study groups Clinical endpoint Conclusion Rachelefsky & Farrar 1274 2013 1a SR SAR (n = 2290) and PAR (n = 800). Sixteen controlled clinical trials ≥2 weeks in duration. Children aged 2–18 years. Measures that assessed impairment and/or risk of comorbid conditions. Intranasal steroids improved risk outcomes associated with asthma and OSA. Rodrigo & Neffen 1272 2011 1a SR with meta analysis 16 trials (n = 5348). SAR:7 studies; PAR: 9 studies. Adults and adolescents ≥12 years: 13 studies; children: 3 studies. FFNS vs placebo. Primary outcomes: rTOSS, iTOSS, rTNSS, and iTNSS. Secondary outcomes: QOL, and adverse effects. FFNS significantly improved rTOSS, iTOSS, rTNSS, and iTNSS scores compared with placebo in patients with SAR and PAR. There were greater improvements in QOL with a favorable safety profile. Penagos et al. 1271 2008 1a Meta-analysis of RDBPCTs 16 trials (n = 2998). MFNS vs placebo. TNSS, individual nasal symptoms, and TNNSS. MFNS was associated with a significant reduction in TNSS and TNNSS. Significant effect was seen for nasal stuffiness/congestion, rhinorrhea, sneezing, and nasal itching. Yamada et al. 673 2012 1b Randomized, placebo controlled, double blind, crossover study PAR (n = 57). MFNS vs placebo for 14 days. Nasal symptom scores, QOL, and sleep quality, ESS. MFNS significantly improved nasal symptoms, QOL, and sleep quality. Significant reduction of the ESS observed in the MFNS group with high sleep disturbance. Meltzer et al. 1276 2010 1b Double-blind, parallel group, placebo-controlled study Adults with PAR, moderate rhinitis and disturbed sleep (n = 30). MFNS 200 μ g vs placebo, 4-week trial. Primary endpoint: AHI. Secondary measures: TNSS, nighttime symptom score, daytime nPIF, nighttime flow limitation index, RQLQ, ESS, WPAI-AS AHI was not statistically significantly different between groups. MFNS significantly improved morning and evening TNSS, nasal obstruction/ blockage/congestion, daily nPIF, ESS, QOL score, and 2 of 5 WPAI–AS domains. Kaiser et al. 1284 2007 1b Double-blind, parallel-group, randomized, placebo-controlled study Adults and adolescents with SAR (n = 299). FFNS 110 μ g vs placebo. Nasal and ocular symptoms on 4-point scale. rTNSS, iTNSS, rTOSS, iTOSS Craig et al. 1275 2003 1b Double-blind, placebo-controlled study PAR (n = 32). Fluticasone NS vs placebo. FFNS significantly improved daily rTNSS, morning pre-dose iTNSS, daily rTOSS, and

patient-rated overall response to therapy. Onset of therapeutic effect occurred at 8 hours after initial administration.

Fluticasone improved subjective sleep vs placebo. There was no difference in the AHI in treated subjects.

Patients treated with FPNS PRN had a significantly greater reduction from baseline in TNSS. Individual symptoms were also significantly improved by active therapy.

Budesonide significantly improved daytime fatigue, somnolence, and quality of sleep vs placebo.

Questionnaires, QOL instruments, daily diary, ESS, and polysomnography.

Mean change from baseline in TNSS.

ESS, Functional Outcomes of Sleep Questionnaire, RQLQ.

Daily diary of nasal symptoms, sleep problems, and daytime fatigue.

Dykewicz et al. 1289 2003 1b RDBPCT Adults and adolescents ≥12 year (n = 241), SAR to fall allergen. FPNS 200 μ g PRN vs placebo for 4 weeks. Hughes et al. 1706 2003 1b Double-blind, placebo controlled, crossover study PAR (n = 22). Budesonide 128 μ g/day or placebo for 8 weeks.

Int Forum Allergy Rhinol . Author manuscript; available in PMC 2020 June 10.