drugset / Trial / NCT07600190
Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)
Phase 1
Not yet recruiting
60 enrolled
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
In this single center, interventional pilot study, 40 participants at high risk for future exacerbation will be randomized to anakinra (v. placebo control) treatment for home administration as part of an asthma action plan (AAP) and monitored through their first moderate asthma exacerbation, triggering treatment dosing over a 26 week period. Key feasibility questions will be assessed in this pilot study to inform trial design and sample size selection for a future multi-site phase II clinical trial testing anakinra as a rescue treatment for moderate asthma exacerbations.
Timeline
- Start
- 2026-11-01
- Primary completion
- 2029-01-01
- Completion
- 2029-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anakinra | Protein / enzyme biologic | 100 mg | — |