xRead - September 2022

Wise et al.

Page 379

Author Manuscript Author Manuscript Author Manuscript Author Manuscript

Study Year LOE Study design Study groups Clinical endpoint Conclusion Chervinsky et al. 1313

No clinically relevant differences observed between the ciclesonide and placebo groups.

Changes in plasma or urine cortisol levels showed no difference in active vs placebo group. Serum concentrations were below the lower limit of

Incidence of adverse events similar to placebo, except epistaxis (active 20%, placebo 8%). No clinically meaningful differences in ophthalmic parameters or urine cortisol excretion.

FP group equivalent to placebo group in mean change from baseline of 12-hour urinary free cortisol at treatment end.

quantification, suggesting that systemic exposure to ciclesonide was low.

Adverse events, exam findings, 24-hour urinary free cortisol, morning plasma cortisol, IOP, lens opacification.

Cortisol levels were measured at the beginning and end of each study. The

systemic exposure of ciclesonide and its active metabolite measured at treatment end in the 6-week study.

Adverse events, 24-hour urinary cortisol excretion, nasal and ophthalmic examinations, electrocardiograms and clinical laboratory tests.

12-hour urinary free cortisol concentration at baseline and after 6 weeks of treatment.

PAR, children 2–5 years. Safety, tolerability, and efficacy of intranasal ciclesonide 200 μ g once daily. First study: 6 weeks. Second study: 12 weeks. PAR (n = 806).

2007 1b RDBPCT PAR patients ≥12 years (n = 663). Ciclesonide 200 μ g vs placebo daily for up to 52 weeks. phase 3, double blind, parallel group, placebo

FF 110 μ g vs placebo daily for 12 months.

Galant et al. 1311 2003 1b RDBPCT AR, children 2-3 years (n = 65). FP 200 μ g vs placebo daily for 6 weeks.

controlled trials

parallel-group

Kim et al. 1312 2007 1b Two separate Rosenblut et al. 1303

2007 1b RDBPCT,

AR = allergic rhinitis; BDP; beclomethasone dipropionate; FF = fluticasone furoate; FP = fluticasone propionate; HPA; hypothalamic pituitary axis; INCS = intranasal corticosteroid; IOP = intraocular pressure; LOE = level of evidence; MFNS = mometasone furoate nasal spray; PAR = perennial allergic rhinitis; RCT = randomized controlled trial; RDBPCT = randomized double-blind placebo-controlled trial; SAR = seasonal allergic rhinitis; SR = systematic review; TAA = triamcinolone acetonide.

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