Health Trials

Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS).

ConditionChronic Rhinosinusitis With Nasal Polyps
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstituto de Investigación Marqués de Valdecilla

About this trial

This randomized, controlled multicenter trial will recruit patients aged 18 to 70 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment.

All study procedures will be performed in five study visits and may take approximately 30 minutes. Clinical assessments include ifferent questionnaires and nasal endoscopy. This trial includes three treatment arms.

1. Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab. 2. Medical group (mepolizumab): This group will receive Mepolizumab. 3. Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy. The main advantage is that it allows comparison of mepolizumab versus surgery and surgery/mepolizumab versus surgery + mepolizumab, providing more information on the most effective therapeutic approach.

The presence of adverse effects will be assessed in each treatment arm.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant 18 years of age or older

Basal eosinophil count (BEC) ≥300 cells/µL for surgical naïve patients- or for those who have had surgery and have recurrence . The result of a previous analysis would be valid if it was obtained in a period of time not exceeding one year

Patients have been informed and signed consent to participate in the study.

Disqualifiers

Any serious or uncontrolled systemic or psychiatric illness that prevents a correct cognitive or endoscopic assessment or does not advise participation in the study.

Unilateral localized secondary CRS (odontogenic, fungal ball, tumor).

Bilateral diffuse secondary CRS (cystic fibrosis; eosinophilic granulomatosis with polyangiitis-S. de Churg-Strauss-; granulomatosis with polyangiitis-S de Wegener-; primary ciliary dyskinesia; selective immunodeficiencies.

Pregnancy/ breast feeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • surgical arm

    Procedure/Surgery

    polypectomy in the office and will not receive mepolizumab treatment.

  • Mepolizumab 100 MG

    Drug

    will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.

  • combined arm

    Other intervention

    in-office nasal polypectomy before starting treatment with mepolizumab. Mepolizumab treatment will be administered at the surgical procedure visit or within 48 hours after the polypectomy.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: surgical armActive comparator 1 intervention
Group B: medical armExperimental treatment 1 intervention
Group C: combined armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

the efficacy of mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score at week 52.

SNOT-22 total score ranges from 0 to 110, with higher scores indicating worse quality of life/more severe symptoms.

Time frame
12 moths

Secondary outcomes

1

Change in nasal polyposis severity VAS score at V1, V6, V12.

VAS score ranges from 0 to 100, with higher scores indicating greater symptom severity.

Time frame
1 month, 6 months and 12 months
2

Change in endoscopic nasal polyp score at V1, V6, V12

Time frame
1 month, 6 months and 12 months
3

Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at V1, V6, V12

Time frame
1 month, 6 months and 12 months
4

Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto de Investigación Marqués de Valdecilla

Lead sponsor

Source ClinicalTrials.gov
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