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RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Biologic Agents for Chronic Sinusitis

The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure.

Official registry: https://clinicaltrials.gov/study/NCT06824649 · Medical University of South Carolina · enrollment listed as 504

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biologic Agents. The registry lists allocation as randomized. The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans.

They plan to enroll about 504 people at 5 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

SMART Use of Biologics in Chronic Rhinosinusitis With Nasal Polyposis

Interventions: Biologic Agents

Primary outcome (registry wording): Disease-Specific Quality of Life

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria
  • Bilateral nasal polyposis visible on sinonasal endoscopy
  • Nasal polyp score \> 5
  • Baseline SNOT-22 total score \> 30
  • Patient elects biologic therapy for the management of CRSwNP
  • Capable of receiving all 3 biologic therapy medications
  • Treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit

Public study contact (from the registry)

Research Associate

(503) 494-5886

ENTResearch@ohsu.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

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FAQ about this NCT record

Is NCT06824649 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06824649?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06824649?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary