Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). (MELYSA)
Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.
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.
- Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab.
- Medical group (mepolizumab): This group will receive Mepolizumab.
- 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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and indication for biologic treatment according to the criteria of the EPOS2020 guideline.
Presence of bilateral polyps in a patient who had endoscopic sinus surgery (ESS) (except in cases where the patient is not fit for surgery) and three of the following criteria are required:
Evidence of type 2 inflammation (tissue eos> 10/hpf* or blood eos>250, OR total IgE> 100).
* Whenever possible histology from previous surgery should be reviewed to confirm if eosinophilic pathology. If the previous surgery was performed more than 2 years earlier, a blood eosinophil count is essential, as the previous biopsy data may not be relevant.
- Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (>3 months)
- Significantly impaired quality of life (SNOT ≥ 40)
- Significant loss of smell (VAS).
- Diagnosis of comorbid asthma
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
-
-
-
Barakaldo, Spanje
- Werving
- Hospital De Cruces
-
Contact:
- Francisco Valcarcel
- Telefoonnummer: +34946006000
- E-mail: patxivalcarcel@gmail.com
-
Jerez de la Frontera, Spanje
- Werving
- Hospital de Jerez
-
Contact:
- Alfonso del cuvillo Bernal
- Telefoonnummer: +34956032000
- E-mail: dr.cuvillo@comcadiz.es
-
Madrid, Spanje
- Werving
- Hospital Puerta del Hierro
-
Contact:
- Antonio Martinez
- Telefoonnummer: +34911916000
- E-mail: amruizcoello@gmail.com
-
Salamanca, Spanje
- Werving
- Hospital de Salamanca
-
Contact:
- Maria gil
- Telefoonnummer: +34923291100
- E-mail: mgilmel@saludcastillayleon.es
-
Santander, Spanje, 39006
- Werving
- Hospital Universitario Marqués de Valdecilla
-
Contact:
- david lobo duro
- Telefoonnummer: +34942315515
- E-mail: david.lobo@scsalud.es
-
Seville, Spanje
- Werving
- Hospital Universitario Virgen Macarena
-
Contact:
- Serafín Sánchez Gómez
- Telefoonnummer: +34955008000
- E-mail: serafin.sanchez.sspa@juntadeandalucia.es
-
Valladolid, Spanje
- Werving
- Hospital de Valladolid
-
Contact:
- Jaime Santos
- Telefoonnummer: +34983420000
- E-mail: jsp002@gmail.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Participant 18 years of age or older
Patients with a diagnosis of CRS with polyposis according to the criteria of the EPOS2020 guideline:
Chronic rhinosinusitis with nasal polyps in adults is defined as presence of two or more symptoms, one of which should be either nasal blockage / obstruction / congestion or nasal discharge (anterior / posterior nasal drip); ± facial pain/pressure; ± reduction or loss of smell; for ≥12 weeks; and either endoscopic signs of nasal polyps, and/or CT changes: mucosal changes within the ostiomeatal complex and/or sinuses.
Patients with indication for biologic treatment according to the criteria of the EPOS2020 guideline. Presence of bilateral polyps in a patient who had ESS and three of the following criteria are required:
3.1. Evidence of type 2 inflammation (tissue eos> 10/hpf* or blood eos>250, OR total IgE> 100).
* Whenever possible histology from previous surgery should be reviewed to confirm if eosinophilic pathology. If the previous surgery was performed more than 2 years earlier, a blood eosinophil count is essential, as the previous biopsy data may not be relevant.
3.2. Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (>3 months)
3.3. Significantly impaired quality of life (SNOT ≥ 40)
3.4. Significant loss of smell (≥7 VAS)
3.5. Diagnosis of comorbid asthma
- 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.
Exclusion Criteria:
- 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.
- Hypersensitivity to mepolizumab or its excipients.
- Patients unable to complete the questionnaire or follow prescribed treatment.
- Patients who are participating in another clinical trial related to polyposis or asthma.
- Previously documented failure with IL-5/IL-5 receptor biologics
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: surgical arm
This group of patients will undergo nasal polypectomy in the office and will not receive mepolizumab treatment.
|
polypectomy in the office and will not receive mepolizumab treatment.
|
|
Experimenteel: medical arm
This group of patients will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.
|
will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.
|
|
Experimenteel: combined arm
This group of patients will undergo 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.
|
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.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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.
Tijdsspanne: 12 moths
|
SNOT-22 total score ranges from 0 to 110, with higher scores indicating worse quality of life/more severe symptoms.
|
12 moths
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in nasal polyposis severity VAS score at V1, V6, V12.
Tijdsspanne: 1 month, 6 months and 12 months
|
VAS score ranges from 0 to 100, with higher scores indicating greater symptom severity.
|
1 month, 6 months and 12 months
|
|
Change in endoscopic nasal polyp score at V1, V6, V12
Tijdsspanne: 1 month, 6 months and 12 months
|
1 month, 6 months and 12 months
|
|
|
Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at V1, V6, V12
Tijdsspanne: 1 month, 6 months and 12 months
|
1 month, 6 months and 12 months
|
|
|
Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study
Tijdsspanne: 12 months
|
12 months
|
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Mepolizumab and/or In-office Nasal Polypectomy
Tijdsspanne: 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months
|
Adverse events collected at each study visit and classified as serious or non-serious per protocol definitions, and by causal relationship to treatment (unrelated, possible, probable) as assessed by the investigator.
|
1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months
|
|
Change from baseline in sinonasal outcome test (SNOT-22) total score at weeks 4 and 24
Tijdsspanne: 1 month and 12 months
|
1 month and 12 months
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MELYSA
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .