Tissue Immune Interaction in Nasal Polyposis

Asthma Clinical Trial

— TIP  

Official title:

Tissue Immune Interaction in Nasal Polyposis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04628442
• Other study ID #: 19-28725
• Secondary ID: 2P01HL107202-06A
• Status: Recruiting
• Start date: November 10, 2020
• Est. completion date: March 2025

Study information

• Verified date: February 2023
• Source: University of California, San Francisco
• Contact: Xavier Orain, BS
• Phone: 415-502-3472
• Email: xavier.orain[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a cross-sectional study of up to 100 subjects who are undergoing clinically indicated sinus procedures to treat chronic rhinosinusitis. Participants will be asked to donate leftover sino-nasal secretions, sino-nasal tissue and blood as well as undergo partial characterization. As optional extensions of the main study, participants may also undergo a biopsy of extra sino-nasal tissue for additional tissue analysis and/or a more detailed characterization visit performed in the UCSF Airway Center Research Center (ACRC).

Description:

This is a cross-sectional study of up to 100 participants who are undergoing clinically indicated sinus procedures to treat chronic rhinosinusitis. 50 participants with CRSwNP and 50 participants with CRS without polyps and no features of atopy will be enrolled in the study. Participants will donate leftover sino-nasal secretions and tissue from their procedures. In addition, participants will be subject to medical record review and research questionnaires. In many instances, these participants will have multiple procedures over time to treat recurrent disease and this study will allow for them to donate leftover biospecimens as many as 9 times. Participants may also opt to undergo a turbinate mucosal tissue biopsy during regularly scheduled sinus surgery for additional tissue analysis and/or undergo a more detailed, complete characterization visit performed in the UCSF Airway Center Research Center (ACRC). During the complete characterization, participants will undergo lung function tests, sputum induction and blood collection, in addition to the procedures mentioned above.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Participants with Chronic Rhinosinusitus with Nasal Polyps

Inclusion Criteria:

• Males or females between the ages 18 to 80 (inclusive).
• History of blood eosinophils > 200 cells/dL (or tissue eosinophilia evident on histopathologic review of sino-nasal tissues).
• Physician diagnosis of chronic rhinosinusitis (CRS).
• Undergoing office-based or operating room-based sinus procedures for a clinical indication.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

• Smoking of tobacco or other recreational inhalants more than twice in the last month and/or >10 pack-year smoking history.
• History of cystic fibrosis or ciliary dyskinesia.
• Currently taking immunosuppressant drugs including Mycophenolate mofetil (Cellcept), Cyclophosphamide (Cytoxan), Azathioprine (Imuran). Participants with Chronic Rhinosinusitus without Nasal Polyps

Inclusion Criteria:

• Males or females between the ages 18 to 80 (inclusive)
• Physician diagnosis of CRS.
• Undergoing office-based or operating room-based sinus procedures for a clinical indication.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

• Smoking of tobacco or other recreational inhalants more than twice in the last month and/or >10 pack-year smoking history.
• Presence of nasal polyps.
• History of allergic rhinitis.
• History of blood eosinophilia > 200 (or tissue eosinophilia evident on histopathologic review of sino-nasal tissues).
• Currently taking immunosuppressant drugs including Mycophenolate mofetil (Cellcept), Cyclophosphamide (Cytoxan), Azathioprine (Imuran).

Related Conditions & MeSH terms

• Asthma
• Chronic Rhinosinusitis (Diagnosis)
• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Sinusitis

Intervention

Procedure:
• Sinonasal Debridement Procedure
This is a medical procedure prescribed by the participant's physician that has been deemed necessary for patient care in order to address their chronic rhinosinusitis.
• Nasal Polyp Removal
This is a surgical procedure prescribed by the participant's physician that has been deemed necessary for patient care in order to address their chronic rhinosinusitis.
• Biopsy
A biopsy is optional and will remove a sample of inferior turbinate tissue from the nasal passage. It will be performed during a nasal polyp removal surgery already scheduled for patient care.

Locations

Country	Name	City	State
United States	UCSF Airway Clinical Research Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of ILC2 and tuft cells	This study enrolls chronic rhinosinusitis patients with and without nasal polyps. Investigators aim to compare the percentage of ILC2 and tuft cells present in nasal tissue and secretions between those who present with nasal polyps and without nasal polyps.	Up to 8 hours

External Links

•   Airway Clinical Research Center website