Trial · NCT05575037
Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease
NCT05575037, Phase 2, Active not recruiting, Brigham and Women's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease. Trials, record NCT05575037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05575037
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease
- NCT number
- NCT05575037
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Nasal Polyps, Asthma, Aspirin-Induced, Aspirin-Exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps
- Interventions
- Dupilumab
- First posted
- 2022-10-12
- Last updated
- 2026-08-13
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Nasal fluid levels of LTE4 | At Week 8 (Visit 3) | The nasal fluid levels of LTE4 will be measured at week 8 and will serve as a surrogate biomarker of respiratory mast cell activation or burden. |
| Secondary | Nasal fluid levels of albumin | At Week 8 (Visit 3) | The nasal fluid levels of albumin will be measured at week 8 and serve as a surrogate biomarker of nasal epithelial cell integrity. |
| Secondary | Sense of smell - University of Pennsylvania Smell Identification Test (UPSIT) | At Week 8 (Visit 3) | Patients' sense of smell will be assessed at week 8 using the UPSIT. The UPSIT scale goes from 0 to 40, with 0 being worse (no scents identified) and 40 being best (all scents identified) |
| Secondary | Rhinoscopic Total Polyp Score (TPS) | At Week 8 (Visit 3) | The extent of patients' nasal polyps will be assessed at week 8 using a TPS. The TPS scale goes from 0 (no polyps) to 8 (large polyps bilaterally), with 0 being best and 8 being worst. |
| Secondary | Peak Nasal Inspiratory Flow (PNIF) | At Week 8 (Visit 3) | Patients' nasal congestion will be assessed at week 8 by a PNIF. PNIF goes from 0 mL (no airflow) to 500 mL of airflow, with 0 being worst. |
| Secondary | Quality of life - 22-Item Sino-Nasal Outcome Test (SNOT-22) | At Week 8 (Visit 3) | Quality of life will be assessed at week 8 with a SNOT-22. For the SNOT-22, the scores range from 0 (no symptoms, excellent disease control) to 110 (maximum sinus symptoms, poor disease control). |
| Secondary | Lung function - Forced Expiratory Volume 1 (FEV1) | At Week 8 (Visit 3) | Patients' lung function will be assessed at week 8 with an FEV1. |
| Secondary | Asthma control - Asthma Control Questionnaire-6 (ACQ-6) | At Week 8 (Visit 3) | Asthma control will be measured at week 8 with an ACQ-6. For the ACQ-6, scores ranging from 0 (well-controlled) to 6 (extremely poorly-controlled). A lower score indicates better asthma control. |
| Secondary | Number of treatment-related adverse events (AEs) and serious adverse events (SAEs) leading to study drug discontinuation | At Week 8 (Visit 3) | Safety will be measured by the number of treatment-related AEs and SAEs leading to dupilumab discontinuation. |
| Other | Change in sense of smell - University of Pennsylvania Smell Identification Test (UPSIT) | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in UPSIT. The UPSIT scale goes from 0 to 40, with 0 being worse (no scents identified) and 40 being best (all scents identified) |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U19AI095219 | Pathophysiologic and Therapeutic Mechanisms of Aspirin Exacerbated Respiratory Disease | Boyce, Joshua A | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2011 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05575037
GET https://conductscience.org/api/trials/v1/NCT05575037/registered?page=2