Other Clinical Trial - Early-onset Dupilumab Effects in CRSwNP

Status Not yet recruiting

Clinical Trial Summary

While it is known that Dupilumab has profound effects in patients with CRSwNP, these are often seen months later after treatment initiation; however, in practice, patients often endorse feeling significantly better within days of their first injection. No studies have investigated the molecular basis for such an acute change. This study proposes that specific cytokine changes in phenotype in addition to microbiome and oscillometry effects play a synergistic role in producing this effect.

Clinical Trial Description

This is a single center, prospective, controlled pilot study investigating the acute-onset changes across multiple parameters from immunology to microbiome and pulmonary physiology in patients with CRSwNP after receiving initial doses of dupilumab therapy. In total, eligible participants will be enrolled in the study for a total of 3 weeks, during which they will receive two injections of 300 mg of dupilumab. There will be a total of 8 study visits with the 1st visit being a 1-month pre-intervention baseline allowing each patient to serve as independent controls. The next seven visits will be at the following time points: Day of the 1st injection, 24-hrs after the first injection, 48 hrs after the first injection, one week after the first injection, two weeks after the first injection prior to receiving the second injection, 24hrs after receiving the 2nd injection and the 3-week timepoint (1 week after the second injection). At each visit, patients will be screened for side effects and nasal endoscopy will be performed as well as collection of nasal secretions via sinus packings that are placed in both nares for five minutes. The packings will subsequently be removed and per the collection protocol will undergo centrifugation, aliquoting and storage in a -80 freezer for future cytokine analysis via ELISA assays for various cytokine markers of type 2 inflammation, neutrophil activity, and mucin type. At specific visits, additional measures will be collected including Staph Aureus swabs for qPCR and cell culture, SNOT-22 surveys and smell testing, and oscillometry. ;

Study Design

Related Conditions & MeSH terms

Chronic Rhinosinusitis With Nasal Polyps
Nasal Polyps
Polyps
Rhinosinusitis

Clinical Trial Details

NCT number	NCT06188871
Study type	Interventional
Source	University of Rochester
Contact	Paul Allen, PhD
Phone	(585) 276-5181
Email	Paul_Allen@URMC.Rochester.edu
Status	Not yet recruiting
Phase	Phase 4
Start date	April 1, 2024
Completion date	December 31, 2026

View Details

See also
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Recruiting	`NCT05891483` - Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps	Phase 2
Recruiting	`NCT04998604` - EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients	Phase 4
Recruiting	`NCT06069310` - Mepolizumab Effectiveness in Patients With Chronic Rhinosinusitis, Nasal Polyps and Comorbid Severe Eosinophilic Asthma
Recruiting	`NCT05009758` - Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps	N/A
Active, not recruiting	`NCT05529784` - Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)
Recruiting	`NCT05902325` - Identifying Predictors Of Response To Mepolizumab In CRSwNP	Phase 4
Completed	`NCT05049122` - Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)	Phase 4
Not yet recruiting	`NCT05598411` - CST1-Guided Oral Glucocorticoids Management for CRSwNP	Phase 4
Active, not recruiting	`NCT05553951` - Adherence in Global Airways	N/A
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Active, not recruiting	`NCT05649813` - A Study in Male and Female Adult Participants With Chronic Rhinosinusitis With Nasal Polyps In the Greater Gulf Region
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Active, not recruiting	`NCT06118554` - 3D Printing to Improve Nasal Irrigation Outcome	N/A
Active, not recruiting	`NCT04596189` - Dupilumab for Prevention of Recurrence of CRSwNP After ESS	Phase 4
Recruiting	`NCT02668861` - Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels	Phase 3
Active, not recruiting	`NCT05878093` - Dupilumab in Chinese Adult Participants With CRSwNP	Phase 3
Completed	`NCT05931744` - The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis	Phase 2/Phase 3
Recruiting	`NCT05938972` - Real Life Study of Biologicals in Patients With Severe CRSwNP

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.