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Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study. (MELYSA)

Primary Purpose

Rhinosinusitis Chronic, Polyp, Nasal

Status
Not yet recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Mepolizumab
Polypeptomy
Sponsored by
Instituto de Investigación Marqués de Valdecilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinosinusitis Chronic

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (except in cases where the patient is not fit for surgery, see bellow) 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). 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 (≥7 VAS) Diagnosis of comorbid asthma Basal eosinophil count (BEC) ≥300 cells/μL for surgical naïve patients- only those not fit for surgery (major criteria) or for those who have had surgery and have recurrence (minor criteria). Patients have been informed and signed consent to participate in the study. For those patients not suitable for surgery, the criteria of the EUFOREA guidelines for indication of biological treatment will be used (4 criteria, one of them being ≥300 cells/μL BEC). 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 it's 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

Sites / Locations

  • Hospital de Curces
  • Hospital de Jerez
  • Hospital Puerta del Hierro
  • HUCA
  • Hospital Universitario Marques de Valdecilla
  • Hospital Virgen Macarena
  • Hospital Valladolid

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Combined group

Medical group

Surgical group

Arm Description

In-office nasal polypectomy group with mepolizumab

(mepolizumab)

In-office nasal polypectomy

Outcomes

Primary Outcome Measures

Mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score

Secondary Outcome Measures

Change in nasal polyposis severity VAS score at 4 weeks, 6 months, 12 months
Change in endoscopic nasal polyp score at 4 weeks, 6 months, 12 months
Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at 4 weeks, 6 months, 12 months
Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study
Number of participants with mepolizumab and in-office nasal polypectomy related adverse events
Change from baseline in sinonasal outcome test
The minimum value is 0 and maximum value is 110

Full Information

First Posted
June 1, 2023
Last Updated
June 19, 2023
Sponsor
Instituto de Investigación Marqués de Valdecilla
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1. Study Identification

Unique Protocol Identification Number
NCT05923047
Brief Title
Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.
Acronym
MELYSA
Official Title
Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Marqués de Valdecilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized, controlled multicenter trial will recruit patients aged 18 to 70 7 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 different 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinosinusitis Chronic, Polyp, Nasal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined group
Arm Type
Experimental
Arm Description
In-office nasal polypectomy group with mepolizumab
Arm Title
Medical group
Arm Type
Experimental
Arm Description
(mepolizumab)
Arm Title
Surgical group
Arm Type
Active Comparator
Arm Description
In-office nasal polypectomy
Intervention Type
Drug
Intervention Name(s)
Mepolizumab
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Polypeptomy
Intervention Description
This group will undergone in-office nasal polypectomy.
Primary Outcome Measure Information:
Title
Mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score
Time Frame
up to 52 weeks
Secondary Outcome Measure Information:
Title
Change in nasal polyposis severity VAS score at 4 weeks, 6 months, 12 months
Time Frame
up to 52 weeks
Title
Change in endoscopic nasal polyp score at 4 weeks, 6 months, 12 months
Time Frame
up to 52 weeks
Title
Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at 4 weeks, 6 months, 12 months
Time Frame
up to 52 weeks
Title
Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study
Time Frame
up to 52 weeks
Title
Number of participants with mepolizumab and in-office nasal polypectomy related adverse events
Time Frame
up to 52 weeks
Title
Change from baseline in sinonasal outcome test
Description
The minimum value is 0 and maximum value is 110
Time Frame
up to 4 and 24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 (except in cases where the patient is not fit for surgery, see bellow) 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). 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 (≥7 VAS) Diagnosis of comorbid asthma Basal eosinophil count (BEC) ≥300 cells/μL for surgical naïve patients- only those not fit for surgery (major criteria) or for those who have had surgery and have recurrence (minor criteria). Patients have been informed and signed consent to participate in the study. For those patients not suitable for surgery, the criteria of the EUFOREA guidelines for indication of biological treatment will be used (4 criteria, one of them being ≥300 cells/μL BEC). 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 it's 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
Facility Information:
Facility Name
Hospital de Curces
City
Bilbao
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Valcarcel
Facility Name
Hospital de Jerez
City
Jerez De La Frontera
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso cuvillo
Facility Name
Hospital Puerta del Hierro
City
Madrid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Martinez
Facility Name
HUCA
City
Oviedo
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Luis Llorente
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39011
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
david Lobo
Email
david.lobo@scsalud.es
Facility Name
Hospital Virgen Macarena
City
Sevilla
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
serafin sanchez
Facility Name
Hospital Valladolid
City
Valladolid
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime santos

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.

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