xRead - Olfactory Disorders (September 2023)

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PATEL et al.

TABLE IX-4 (Continued)

Clinical end point

Study Rawal

Year 2015

LOE Study design Study groups

Conclusions Compared with

UPSIT R PEA threshold test Data collection points: week 1 to 2, week 3 to 8, and month 3 to 6

2

RCT

CRSwNP (N = 50) Budesonide nasal irrigation 0.12 mg twice daily (n = 25) Saline irrigations twice daily (n = 25)

et al 1408

baseline, neither group demonstrated significant benefit on USPIT or PEA test at any time point

Topical

corticosteroid: exhalation driven delivery

Compared with

Subjective

Sindwani et al 1409

2019

2

RCT

CRSwNP (N = 323) FPEDS327 μ g twice daily × 24weeks (n = 79) FPEDS 186 μ g twice daily × 24weeks (n = 80) FPEDS93 μ g twice daily × 24weeks (n = 81) Placebo EDS × 24weeks (n = 82) daily × 24weeks (n = 82) FPEDS 186 μ g twice daily × 24weeks (n = 80) FPEDS93 μ g twice daily × 24weeks (n = 80) Placebo EDS × 24weeks (n = 79) CRSwNP (N = 323) FPEDS327 μ g twice

placebo, FP groups demonstrated significant greater benefit in olfactory subjective symptom score at majority of time points

symptom score (0–3)

Data collection

points: week 4, week 8, week 12, week 16

Leopold

2019

2

RCT

Subjective

Compared with

et al 1410

symptom score (0–3)

placebo, all FP EDS dosing groups demonstrated significantly greater benefit in subjective symptom score at all time points

Data collection

points: week 4, week 8, week 12, week 16, week 24

Compared with baseline, both groups demonstrated

Kobayashi et al 1411

OSIT-J Data collection point: week 4

2018

2

RCT

CRSwNP (N = 23) Exhaled

Hydrofluoroalkane 134a beclomethasone dipropionate via metered dose inhaler × 4weeks

significant benefit

Compared with

placebo, the exhaled corticosteroid group did not demonstrate any significant benefit improvement compared with placebo at all time points and at all doses

Placebo (n = 12)

Soteres

2017

2

RCT

CRSwNP (N = 323) FPEDS327 μ g twice daily × 24weeks (n = 82) FPEDS 186 μ g twice daily × 24weeks (n = 80) FPEDS93 μ g twice daily × 24weeks (n = 80) Placebo × 24weeks (n = 79)

Subjective

Significant

et al 1412

symptom score (0–3)

Data collection

points: week 4, week 8, week 12, week 16, week 24

(Continues)