University of North Carolina, Chapel Hill
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.
This pilot study will incorporate early intervention with the IL-1 receptor antagonist (IL-1RA), anakinra, as part of a home-based asthma action plan (AAP) at the start of a moderate exacerbation with the goal of preventing severe exacerbations requiring systemic steroids. The investigators will determine the feasibility of recruitment, enrollment, and retention for a trial that requires self administered injections; adherence to critical protocol operational tasks and rates of moderate exacerbations; and preliminary safety and efficacy of anakinra treatment during a moderate asthma exacerbati…
Inclusion Criteria: * Provision of signed and dated informed consent form * Age ≥18 years * A history of physician-diagnosed persistent asthma or symptoms consistent with persistent asthma based on national or international guidelines for diagnosis and management of asthma. * Current use of controller therapy such as inhaled corticosteroid (ICS) or ICS in combination with long-acting beta agonist (LABA) * Asthma exacerbation requiring systemic corticosteroid therapy in the past 12 months * Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy or who have been amen…
Active study treatment
Placebo
Arctuva estimate
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