xRead - Olfactory Disorders (September 2023)

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INTERNATIONAL CONSENSUS ON OLFACTION

TABLE IX-4 (Continued)

Clinical end point VAS (0–100) Mean sense of smell disorder score Data collection

Study

Year 2009

LOE Study design Study groups

Conclusions Compared with

Janowski et al 1391

2

RCT

CRSwNP (N = 246) FPNS200 μ g twice daily × 8months FPNS200 μ g twice daily × 1 month, followed byFPNS200 μ gonce daily + placebo once daily × 7months Placebo twice daily × 2 months, followed by FPNS200 μ g twice daily for 6 months CRSwNP (N = 68) FPNS400 μ g twice daily Placebo spray twice daily

placebo, both FP groups demonstrated significantly greater improvement in VAS (only at month 1) and mean sense of smell disorder score (only month 1 and month2)

points: month 1, month 2, and month8

Ehnhage et al 1392

2009

2

RCT

Subjective

Compared with

symptom score (0–3)

placebo, there was no significant benefit in the FP group

BTS Data collection point: week 4

Compared with

Small

Subjective

2008

2

RCT

CRSwNP (N = 447) MFNS200 μ g twice daily (n = 224) Placebo (n = 223)

et al 1393

placebo, the MF group demonstrated significantly greater improvement in subjective symptom score first on day 13 and remained significantly elevated throughout study duration placebo, the MF group demonstrated significantly greater improvement in subjective symptom score and BTS at all time points placebo, the MF 200 μ g twice-daily dosing group demonstrated significantly greater improvement in smell at W4. No significant benefit with every day dosing placebo, the FP group demonstrated significantly greater improvement in VAS at week 12 only

symptom score (0–3) points: daily for 6.5weeks

Data collection

Stjärne

2006

2

RCT

CRSwNP (N = 298) MFNS200 μ g once daily (n = 153) Placebo (n = 145)

Subjective

Compared with

et al 1394

symptom score (0–3)

BTS Data collection

points: week 4, week 8, week 12, week 16 symptom score (0–3) points: week 4, week 12

Compared with

Stjärne

Subjective

2006

2

RCT

CRSwNP (N = 310) MFNS200 μ g once daily am and placebo in Pm (n = 102) MFNS200 μ g twice daily (n = 102) Placebo am and pm (n = 106)

et al 1395

Data collection

Aukema

2005

2

RCT

CRSwNP (N = 54) FPNS400 μ g once daily (n = 27) Placebo (n = 27)

VAS loss of smell (0–100) Data collection

Compared with

et al 1396

points: week 2, week 6, week 12

(Continues)