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New treatment option for Chronic Sinusitis
Official title Biologics in Chronic Rhinosinusitis With Nasal Polyposis
ClinicalTrials.gov ID: NCT06824649
What this study is testing
What is Biologic Agents?
Biologic Agents is an investigational medicine, being studied as a potential treatment for chronic sinusitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \> 18 years
- 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
You likely can't join if
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Endoscopic sinus surgery within 6-months preceding enrollment / randomization.
- Oral corticosteroid use within 30-days preceding enrollment / randomization.
- Serum IgE level outside the dosing range for omalizumab (i.e., \<30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA...
- Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care.
- Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization.
See the full eligibility criteria
- Age \> 18 years
- 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.
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Endoscopic sinus surgery within 6-months preceding enrollment / randomization.
- Oral corticosteroid use within 30-days preceding enrollment / randomization.
- Serum IgE level outside the dosing range for omalizumab (i.e., \<30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)
- Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care.
- Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization.
- Any previous treatment with any of the 3 biologic medications.
- Comorbid cystic fibrosis, CVID, or ciliary dyskinesia.
- Comorbid systemic inflammatory disorders (e.g., GPA, EGPA, Sarcoidosis, SLE)
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks for participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.