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NCT05031455 · ClinicalTrials.gov registry record · Phase 2
Mechanisms of Dupilumab in AERD
A Phase 2 study of Aspirin-exacerbated Respiratory Disease, sponsored by Scripps Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05031455: Recruiting Phase 2 study of Aspirin-exacerbated Respiratory Disease, sponsored by Scripps Clinic.
NCT05031455 is a Phase 2 study of Aspirin-exacerbated Respiratory Disease that is actively recruiting participants, run by Scripps Clinic. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05031455, a Phase 2 study of Aspirin-exacerbated Respiratory Disease, is actively recruiting participants, sponsored by Scripps Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Aspirin-Exacerbated Respiratory Disease (AERD), although uncommon in the general population, is an important phenotype of severe asthma and nasal polyposis where it occurs in 15% of severe asthmatics, and up to 30% of those with nasal polyposis. An important therapy for AERD is aspirin therapy after desensitization (ADAT). This is an inexpensive and proven therapy to improve the burden of sinus disease in AERD. Aspirin desensitization is the mechanism by which tolerance is induced in AERD patients. This is a 1-2 day outpatient procedure whereby increasing doses of aspirin are administered and the patients invariably experience some degree of hypersensitivity reactions. It is important to understand the effect of medications on the aspirin desensitization. It is known that the leukotriene modifier medications decrease the severity of the reactions in AERD. Other treatments such as antihistamines and the biologic agent omalizumab might have an effect on either blocking or blunting reactivity in AERD during desensitization. Dupilumab is a new respiratory biologic approved for atopic dermatitis, eosinophilic asthma and nasal polyposis. As such, it is well situated to be used for many AERD patients whose disease cannot be well controlled. The effect of dupilumab on the aspirin desensitization process and reaction is unknown and is the topic of this investigation. The primary objective is to determine the effect of dupilumab on reactions during aspirin challenge/desensitization.
Primary Outcome
Aspirin challenge reactions will be defined as either 1) \>15% drop in FEV1 or 2) \>25% drop in peak nasal inspiratory flow (PNIF) or 3) \>5 point change in composite symptom score. Spirometry is a standardized measure of airflow obstruction used to define lower airway reaction to aspirin in AERD. Nasal inspiratory flow rates are measured using an inverted peak flow meter and have been correlated with nasal obstruction occurring during nasal reactions to aspirin in AERD. Symptom Score - sympt
Conditions Studied
Interventions
- DRUG Aspirin Challenge
Study Locations (1)
California
- Scripps Clini - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-03-25 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
What NCT05031455 shows while recruiting
NCT05031455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Aspirin-exacerbated Respiratory Disease appearing as the primary indexed condition, and to 1 intervention - of which Aspirin Challenge is the first listed.
NCT05031455 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05031455 about?
NCT05031455 is a clinical study titled "Mechanisms of Dupilumab in AERD". Aspirin-Exacerbated Respiratory Disease (AERD), although uncommon in the general population, is an important phenotype of severe asthma and nasal polyposis where it occurs in 15% of severe asthmatics, and up to 30% of those with nasal polyposis. An important therapy for AERD is aspirin therapy after...
What is the current status of trial NCT05031455?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2024-03-25. Estimated completion is 2026-02-28.
What conditions does trial NCT05031455 study?
This clinical trial studies the following conditions: Aspirin-exacerbated Respiratory Disease.
What interventions are being tested in trial NCT05031455?
The interventions under investigation include: Aspirin Challenge (DRUG).
Who is sponsoring clinical trial NCT05031455?
This trial is sponsored by Scripps Clinic, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05031455 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05031455's enrollment target sits among peer trials
16 1909th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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