Nasal PolypsRECAP-5NCT05672030
Role of IL-5R Signaling in Non-eosinophil Upper Airway Cells in CRSwNP
An observational study of Nasal Polyps and Aspirin-exacerbated Respiratory Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The overarching hypothesis of this proposal is that IL-5 acts on multiple sinus tissue cell types, including plasma cells and epithelial cells, to promote immune dysregulation, and that inhibition of IL-5 affects several relevant effector pathways that lead to clinical benefit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Polyps, Aspirin-exacerbated Respiratory Disease
- What is being tested?
- Non-Interventional
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: AERD, CRSwNP, healthy controls undergoing planned elective sinus surgery.
Who may be able to join
- AERD, CRSwNP, healthy controls
Who cannot join
- Not on any systemic steroids or respiratory biologics at time of surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Role of Interleukin 5 (IL-5) and IL-5R Signaling in Non-eosinophil Upper Airway Cells in Chronic Rhinosinusitis With Nasal Polyps
The overarching hypothesis of this proposal is that IL-5 acts on multiple sinus tissue cell types, including plasma cells and epithelial cells, to promote immune dysregulation, and that inhibition of IL-5 affects several relevant effector pathways that lead to clinical benefit.
Read the detailed description
Further characterization of the role of IL-5Rα expression and function on human plasma cells will determine whether inhibiting IL-5 signaling on these cells offers therapeutic promise in other diseases related to plasma cell proliferation. Further characterization of human upper airway epithelial cell IL-5Rα expression and function will determine whether or not inhibiting IL-5 signaling on these cells offers therapeutic promise in other diseases related to epithelial dysfunction. IL-5Rα expression has been identified on several relevant sinus tissue effector cells, including on nasal polyp plasma cells and epithelial cells, and the aim of this study is to further the field by determining the consequences of IL-5 signaling on those cells.
- Being tested
- Non-Interventional
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin-exacerbated respiratory disease (AERD) | Aspirin-exacerbated respiratory disease (AERD) Receives: Other: Non-Interventional | |
| Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP) | Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP) Receives: Other: Non-Interventional | |
| Healthy controls | Individuals who do not have AERD or CRSwNP Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Nasal Polyp Plasma Cell Transcriptome
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.
Measured: At baseline
Secondary outcomes (2)
Number of Participants With Functional Readouts of IL-5Ra on Nasal Polyp Plasma Cells.
We will determine the number of participants from whom a readout of IL-5Ra is analyzable from the plasma cells in their nasal tissue
Measured: At baseline
Number of Patients for Whom IL-5Ra Signaling on Nasal Epithelial Cells Can be Analyzed
We will determine the number of participants from whom IL-5-elicited signaling on their nasal epithelial tissue can be analyzed.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Oct 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Laidlaw, MD, Brigham and Women's Hospital
- Investigators
- Tanya Laidlaw, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672030
- Sponsor's protocol ID
- 2003P002088
- Acronym
- RECAP-5
- Status last verified
- Nov 2025
- First submitted
- 3 Jan 2023
- Last updated
- 24 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Interleukin 5 (IL-5) and IL-5R Signaling in Non-eosinophil Upper Airway Cells in Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT05672030
- Acronym / sponsor ID
- RECAP-5 / 2003P002088
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Jan 2023 (actual)
- Results
- Posted 24 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching hypothesis of this proposal is that IL-5 acts on multiple sinus tissue cell types, including plasma cells and epithelial cells, to promote immune dysregulation, and that inhibition of IL-5 affects several relevant effector pathways that lead to clinical benefit.
Detailed description
Further characterization of the role of IL-5Rα expression and function on human plasma cells will determine whether inhibiting IL-5 signaling on these cells offers therapeutic promise in other diseases related to plasma cell proliferation. Further characterization of human upper airway epithelial cell IL-5Rα expression and function will determine whether or not inhibiting IL-5 signaling on these cells offers therapeutic promise in other diseases related to epithelial dysfunction. IL-5Rα expression has been identified on several relevant sinus tissue effector cells, including on nasal polyp plasma cells and epithelial cells, and the aim of this study is to further the field by determining the consequences of IL-5 signaling on those cells.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aspirin-exacerbated respiratory disease (AERD) | – | Other: Non-InterventionalAspirin-exacerbated respiratory disease (AERD) |
| Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP) | – | Other: Non-InterventionalAspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP) |
| Healthy controls | – | Other: Non-InterventionalIndividuals who do not have AERD or CRSwNP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- AERD, CRSwNP, healthy controls undergoing planned elective sinus surgery.
Key inclusion criteria (1 listed)
- AERD, CRSwNP, healthy controls
Key exclusion criteria (1 listed)
- Not on any systemic steroids or respiratory biologics at time of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNo intervention. | Other | Aspirin-exacerbated respiratory disease (AERD), Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP), Healthy controls |
Primary outcome
Number of Participants With Nasal Polyp Plasma Cell Transcriptome
Time frame: At baseline
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.
2 secondary outcomes
Number of Participants With Functional Readouts of IL-5Ra on Nasal Polyp Plasma Cells.
Time frame: At baseline
Number of Patients for Whom IL-5Ra Signaling on Nasal Epithelial Cells Can be Analyzed
Time frame: At baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Nasal Polyps
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Laidlaw principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Polyps and Aspirin-exacerbated Respiratory Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Nasal Polyp Plasma Cell Transcriptome (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.