Trial Outcomes & Findings for Role of IL-5R Signaling in Non-eosinophil Upper Airway Cells in CRSwNP (NCT NCT05672030)
NCT ID: NCT05672030
Last Updated: 2025-11-24
Results Overview
We will determine the number of participants from whom a transcriptional profile of nasal polyp plasma cells is analyzable from bulk RNA sequencing of sorted nasal polyp plasma cells.
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
At baseline
Results posted on
2025-11-24
Participant Flow
Participant milestones
| Measure |
Aspirin-exacerbated Respiratory Disease (AERD)
Aspirin-exacerbated respiratory disease (AERD)
Non-Interventional: No intervention.
|
Aspirin-tolerant Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP)
Non-Interventional: No intervention.
|
Healthy Controls
Individuals who do not have AERD or CRSwNP
Non-Interventional: No intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Role of IL-5R Signaling in Non-eosinophil Upper Airway Cells in CRSwNP
Baseline characteristics by cohort
| Measure |
Aspirin-exacerbated Respiratory Disease (AERD)
n=10 Participants
Aspirin-exacerbated respiratory disease (AERD)
Non-Interventional: No intervention.
|
Aspirin-tolerant Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
n=10 Participants
Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP)
Non-Interventional: No intervention.
|
Healthy Controls
n=10 Participants
Individuals who do not have AERD or CRSwNP
Non-Interventional: No intervention.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 years
n=9 Participants
|
52 years
n=6 Participants
|
49 years
n=9 Participants
|
52 years
n=205 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
18 Participants
n=205 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
12 Participants
n=205 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
3 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
3 Participants
n=205 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
23 Participants
n=205 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
PRIMARY outcome
Timeframe: At baselineWe will determine the number of participants from whom a transcriptional profile of nasal polyp plasma cells is analyzable from bulk RNA sequencing of sorted nasal polyp plasma cells.
Outcome measures
| Measure |
Aspirin-exacerbated Respiratory Disease (AERD)
n=10 Participants
Aspirin-exacerbated respiratory disease (AERD)
Non-Interventional: No intervention.
|
Aspirin-tolerant Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
n=10 Participants
Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP)
Non-Interventional: No intervention.
|
Healthy Controls
n=10 Participants
Individuals who do not have AERD or CRSwNP
Non-Interventional: No intervention.
|
|---|---|---|---|
|
Number of Participants With Nasal Polyp Plasma Cell Transcriptome
|
10 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At baselineWe will determine the number of participants from whom a readout of IL-5Ra is analyzable from the plasma cells in their nasal tissue
Outcome measures
| Measure |
Aspirin-exacerbated Respiratory Disease (AERD)
n=10 Participants
Aspirin-exacerbated respiratory disease (AERD)
Non-Interventional: No intervention.
|
Aspirin-tolerant Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
n=10 Participants
Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP)
Non-Interventional: No intervention.
|
Healthy Controls
n=10 Participants
Individuals who do not have AERD or CRSwNP
Non-Interventional: No intervention.
|
|---|---|---|---|
|
Number of Participants With Functional Readouts of IL-5Ra on Nasal Polyp Plasma Cells.
|
10 Participants
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At baselineWe will determine the number of participants from whom IL-5-elicited signaling on their nasal epithelial tissue can be analyzed.
Outcome measures
| Measure |
Aspirin-exacerbated Respiratory Disease (AERD)
n=10 Participants
Aspirin-exacerbated respiratory disease (AERD)
Non-Interventional: No intervention.
|
Aspirin-tolerant Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
n=10 Participants
Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP)
Non-Interventional: No intervention.
|
Healthy Controls
n=10 Participants
Individuals who do not have AERD or CRSwNP
Non-Interventional: No intervention.
|
|---|---|---|---|
|
Number of Patients for Whom IL-5Ra Signaling on Nasal Epithelial Cells Can be Analyzed
|
10 Participants
|
10 Participants
|
10 Participants
|
Adverse Events
Aspirin-exacerbated Respiratory Disease (AERD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aspirin-tolerant Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tanya M. Laidlaw, MD, Associate Professor of Medicine
Brigham and Women's Hospital, Allergy and Clinical Immunology
Phone: 6177329850
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place