Mepolizumab and in-office nasal polypectomy in patients with chronic rhinosinusitis (CRS). A three arm study.

Conditions

chronic rhinosinusitis (CRS)

Brief summary

SINO-NASAL OUTCOME TEST (SNOT-22)

Detailed description

VAS score for nasal symptoms, The following measurement will be assessed using a nasopharyngoscope: 1. CRSwNP: Lund-Kennedy scale 2. CRSwNP: Meltzer scale, Need of rescue therapy with systemic corticosteroids: dose, route of administration, length of treatment, number of treatments., Need of rescue surgery (either in-office polypectomy or full endoscopic sinus surgery), The resected polyp in the polypectomy groups will be sent for histology to confirm that it is eosinophilic and to obtain evidence of type 2 inflammation (tissue eos> 10/hpf), The safety of the treatment will be assessed by collecting Adverse Events at each of the study visits.

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Interventions

DRUGNucala 100 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
SINO-NASAL OUTCOME TEST (SNOT-22)	—

Secondary

Measure	Time frame
VAS score for nasal symptoms, The following measurement will be assessed using a nasopharyngoscope: 1. CRSwNP: Lund-Kennedy scale 2. CRSwNP: Meltzer scale, Need of rescue therapy with systemic corticosteroids: dose, route of administration, length of treatment, number of treatments., Need of rescue surgery (either in-office polypectomy or full endoscopic sinus surgery), The resected polyp in the polypectomy groups will be sent for histology to confirm that it is eosinophilic and to obtain evidence of type 2 inflammation (tissue eos> 10/hpf), The safety of the treatment will be assessed by collecting Adverse Events at each of the study visits.	—

Measure

Time frame

VAS score for nasal symptoms, The following measurement will be assessed using a nasopharyngoscope: 1. CRSwNP: Lund-Kennedy scale 2. CRSwNP: Meltzer scale, Need of rescue therapy with systemic corticosteroids: dose, route of administration, length of treatment, number of treatments., Need of rescue surgery (either in-office polypectomy or full endoscopic sinus surgery), The resected polyp in the polypectomy groups will be sent for histology to confirm that it is eosinophilic and to obtain evidence of type 2 inflammation (tissue eos> 10/hpf), The safety of the treatment will be assessed by collecting Adverse Events at each of the study visits.

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Countries

Spain

Outcome results

None listed