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Wise et al.

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Author Manuscript Author Manuscript Author Manuscript Author Manuscript TABLE IX.B.2.c-4.

Studies evaluating adverse effects of intranasal corticosteroids Study Year LOE Study design Study groups Clinical endpoint Conclusion Ahmadi et al. 1319 2015 1a SR 19 studies of INCS reporting original ocular endpoints (10 RCTs, 1 case control, 8 case series) included. IOP, lens opacity, glaucoma or cataract incidence. None of the 10 RCTs reporting IOP demonstrated changes vs control. None of the 6 RCTs reporting cataract or lens opacity demonstrated changes vs control. Mener et al. 1320 2015 1a SR with meta analysis 8 RCTs (n = 755) investigating INCS for AR in children 3-12 years. Interval change in growth. Knemometry (n = 342 participants, duration 2–4 weeks). Stadiometry (n = 413 participants, duration 12 months). Knemometry studies: Mean growth lower among children using INCS. Stadiometry studies: No Verkerk et al. 1305 2015 1a SR 34 studies (11 RCTs, 5 cohorts, 20 case series) included. Hampel et al. 1317 2015 1b RDBPCT PAR, children 6–11 years. BDP 800 μ g daily (n = 67) vs placebo (n = 32) for 6 weeks. RDBPCTs, focusing on the significant growth difference in INCS vs placebo. Limitations: Difficulty in predicting longer-term or catch-up growth. Histopathology of nasal mucosa. Mucosal atrophy reported in 17 studies.

The concept of nasal mucosal atrophy is poorly defined. No histological evidence for deleterious effects from INCS use on human nasal mucosa.

Serum cortisol values remained stable in both groups. Concentration-time profiles similar for the placebo and BDP groups at baseline and week 6.

Epistaxis 4% in both active and placebo groups. No differences between groups for IOP, and no posterior subcapsular cataracts. No difference in HPA measures between groups.

Symptom control and safety. There was appropriate symptom control in both groups. Adverse events were mild. Incidence of 24-hour serum and urinary cortisol. FF plasma measurements.

epistaxis was 12.7% with MFNS and 9.4% for BDP. FF was non-inferior to placebo with respect to 24 hour serum cortisol. Urinary cortisol excretion over 24 hour at baseline and end of treatment similar between treatment groups.

Adverse event rates comparable between groups. No significant change from baseline in serum cortisol levels after cosyntropin infusion.

Distribution by stature-for-age percentile remained stable.

Epistaxis 6% in all groups. There were no significant ophthalmic or HPA related side effects in the treated subjects. The lower dose of FF reduced nasal symptoms.

Ratio from baseline in serum cortisol weighted mean: FF noninferior to placebo, prednisone significantly reduced the ratio. 24-hour urinary cortisol excretion was similar in the FF and placebo groups. Plasma levels of FF were undetectable after 6 weeks of treatment.

Change in 24-hour serum cortisol from baseline.

Different endpoints, which included: adverse event monitoring, nasal

examinations, ophthalmic examinations, 24-hour urinary cortisol excretions, and serum cortisol concentrations.

Adverse events, morning serum cortisol levels, and growth as measured using office stadiometry.

Nasal symptom scores for efficacy. Nasal and ophthalmic examinations, and HPA assessments for safety.

Change in 24-hour serum cortisol and 24-hour urinary free cortisol, total 24 hour urinary free cortisol, 6-beta

hydroxycortisol excretion, and plasma concentration of FF.

PAR, children 6–11 years (n = 255). MFNS 100 μ g vs BDP 168 μ g daily for 12 months.

HPA axis safety: 6-week U.S. study. FF 55 μ g vs FF 110 μ g vs placebo daily (n = 948).

PAR, children 2–11 years (n = 558). FF 110 μ g vs FF 55 μ g vs placebo daily for 12 weeks.

PAR, children 2–5 years (n = 474). TAA 110 μ g vs placebo daily for 4 weeks.

PAR, children 2–11 years (n = 112). FF 110 μ g vs placebo daily for 6 weeks.

PAR, 12–65 years (n = 112). FF 110 μ g daily for 6 weeks vs

INCS use with or without control group.

SAR: 2-week U.S. study. PAR: 12-week global study.

prednisone 10 mg daily for last 7 days of study vs placebo.

6-11 age group

randomized,

controlled trial

randomized

parallel-group study

multicenter,

parallel-group

placebo

controlled study

parallel-group

Meltzer et al. 1302 2009 1b Subanalysis of 3

Ratner et al. 1304 2009 1b Multicenter, Tripathy et al. 1316

2009 1b Double-blind,

2009 1b RDBPCT,

2008 1b Double-blind,

Patel et al. 1314 2008 1b RDBPCT,

Weinstein et al. 1315

Maspero et al. 1301

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