Mepolizumab for Chronic Rhinosinusitis with Nasal Polyps

Identifying Predictors Of Response To Mepolizumab In CRSwNP

Recruiting Phase 4 Interventional Study
Chronic Rhinosinusitis With Nasal Polyps
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) · Other
Who this trial is looking for

This trial is looking for people with chronic rhinosinusitis and nasal polyps to learn about how well mepolizumab works for them. Participants will need to have certain symptoms and medical history, including prior nasal polyp surgery.

Are You a Good Fit for This Trial?
Must be taking Nasal steroids
Rules you out Cystic fibrosisChurg Strauss syndrome

You may be able to join if

  • I have been diagnosed with chronic rhinosinusitis with nasal polyps.
  • I have had at least one nasal polyp surgery in the last 10 years.
  • I have severe nasal polyps symptoms that may require surgery.
  • I have ongoing treatment with nasal steroids for at least 4 weeks.
  • I have had at least 2 chronic sinus symptoms for at least 12 weeks.

You may not be able to join if

  • I have cystic fibrosis.
  • I have had any recent sinus or upper respiratory infection.
  • I have had any nasal surgery in the last 6 months.
  • I have a history of drug allergies that would prevent my participation.
  • I am currently pregnant or breastfeeding.
  • I have a known medical history of HIV infection.
  • I have had recent radiation therapy or investigational treatments.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
The investigators propose a real-world study to assess the mechanism of action of long-lasting response to mepolizumab in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and identify clinically useful predictors of response. Mepolizumab is a monoclonal antibody targeting IL-5 and is approved for use in asthma and CRSwNP. In clinical studies, 12 months of treatment with mepolizu…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Bilateral NP, as diagnosed by endoscopy or historical CT scan * At least one NP surgery\* within the last 10 years. * Severe NP symptoms consistent with a need for surgery (obstruction VAS symptom score\>5, overall, VAS symptom score \>7, endoscopic bilateral NP score ≥4 \[wit…
Contacts

Martin Yvon Desrosiers, MD

514-890-8000

desrosiers_martin@hotmail.com

CONTACT

Leandra Mfuna Endam, Msc

514-890-8000

leandra.mfuna-endam.chum@ssss.gouv.qc.ca

CONTACT