A Phase 1 interventional study of Anakinra 100 Mg/0.67 Ml Inj Syringe and Saline Placebo/0.67 Ml Inj Syringe in Asthma (Diagnosis), Persistent Asthma and Moderate Asthma Exacerbation, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by University of North Carolina, Chapel Hill · Phase 1, Interventional, and Treatment
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 exacerbation, with the goal of these findings supporting the development a hybrid decentralized phase II trial.
40 adults (≥18 years and \< 65 years) with persistent asthma that experienced an exacerbation within the prior 12 months requiring systemic steroid treatment will be enrolled, with the aim to randomize 20 women and 20 men. Up to 100 subjects will be screened to randomize 40 subjects.
Patients are to receive anakinra or placebo during a moderate asthma exacerbation (defined by pre-specified criteria). Investigators will monitor symptom scores, lung function measurements, rescue medication use, systemic corticosteroid use, and healthcare utilization during exacerbations. Device training, blood collection, and nasal sample collection will also occur.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 60 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinical contraindications:
Usage of the following medications:
Laboratory: Participants who meet the following criteria will be excluded from study:
Subjects will be randomized to receive two doses of active study treatment (anakinra) upon meeting orange zone exacerbation criteria.
Drug: Anakinra 100 Mg/0.67 Ml Inj Syringe
Subjects will be randomized to receive two doses of placebo upon meeting orange zone exacerbation criteria.
Drug: Saline Placebo/0.67 Ml Inj Syringe
Active study treatment
Placebo
Effect of Anakinra on absolute change in morning PEF from baseline during moderate asthma exacerbation
Area under the curve (AUC) of the absolute change from baseline, over the period of treatment day 1 through 10 days post-treatment day 1, calculated using the trapezoidal method, and comparing Anakinra to placebo treatment.
Time frame: Day 1 of treatment through day 10 after treatment
Study Design Feasibility - Percentage of participants who experience one moderate asthma exacerbation
Percent of randomized participants who experience one moderate asthma exacerbation (as defined by the participant's asthma action plan) during the 6-month study period.
Time frame: The 6-month period from randomization to the end of study visit
Effect of Anakinra on Asthma Index during moderate asthma exacerbation
Asthma Index is a continuous variable that reflects the magnitude and timing of changes in asthma control. Asthma scores are calculated using objective peak expiratory flow (PEF) and subjective symptom score elements over a 48-hour period. Asthma scores will be calculated over the period of treatment day 1 through 10 days post-treatment day 1 and subtracted from the mean Asthma score from a stable baseline 7-day period to obtain the Asthma Index. The area under the curve (AUC) of the Asthma Index will be calculated over the period of treatment day 1 through 10 days post-treatment day 1. Higher Asthma Index AUC values represent a greater cumulative burden of uncontrolled asthma relative to the individual's stable baseline (i.e., worse asthma control), while lower values represent better-maintained asthma control over the assessment period.
Time frame: Day 1 of treatment to day 10 after treatment
Intervention Feasibility - Mean number of participants enrolled per month
Mean number of participants completing the screening visit and signing informed consent per month.
Time frame: 18 months
Intervention Feasibility - Mean number of participants randomized per month
Mean number of participants completing the training and randomization visit per month.
Time frame: 18 months
Intervention Feasibility - Percentage of participants retained through completion of study
Percentage of total randomized participants who complete visit 9 (end of study visit).
Time frame: 24 months
Study Design Feasibility - Percentage of participants completing daily PEF measurements
Percentage of randomized participants who complete at least 75% of expected daily PEF measurements.
Time frame: 24 months
Fidelity to Study Intervention - Percentage of prescribed doses of study treatment that are self-administered by the participant
Percentage of prescribed doses of study treatment that are completed through self-administration by the study participant during treatment visit 1 or treatment visit 2.
Time frame: 24 months
Percentage of participants requiring rescue systemic corticosteroid treatment
Among participants who experience an exacerbation event, the percentage who require treatment with systemic corticosteroids for ongoing symptoms and/or PEF reduction.
Time frame: The 10 day period following the start of treatment for an exacerbation
Percentage of participants with rebound worsening of asthma exacerbation after study treatment
Among participants who experience an exacerbation event, the percentage who experience rebound worsening of the asthma exacerbation will be reported. Rebound worsening of asthma exacerbation is defined as an initial improvement in symptoms, short acting beta-agonist (SABA) use and/or peak expiratory flow (PEF) after study treatment with subsequent deterioration shown by a decline in PEF, increased SABA use, or need for systemic corticosteroids during Visits T4-T7.
Time frame: The 10 day period following the start of treatment for an exacerbation
Percentage of participants experiencing an asthma exacerbation that requires emergency care
Among participants who experience an exacerbation event, the percentage who require emergency care, defined as an unscheduled primary care visit, urgent care visit, or emergency department visit, will be reported.
Time frame: The 10 day period following the start of treatment for an exacerbation
Percentage of participants experiencing an asthma exacerbation that requires hospitalization.
Among participants who experience an exacerbation event, the percentage who require hospitalization will be reported
Time frame: The 10 day period following the start of treatment for an exacerbation
Percentage of participants with post-treatment severe neutropenia.
Among participants who inject study treatment for an exacerbation, the percentage with post-treatment severe neutropenia will be reported. A post treatment complete blood count (CBC) will be performed and severe neutropenia will be defined as an absolute neutrophil count (ANC) \< 500 cells/µL.
Time frame: 14 days following the start of treatment for an exacerbation
Percentage of participants experiencing serious infection
Among participants who inject study treatment for an exacerbation, the percentage who experience a serious infection (including pneumonia, cellulitis, kidney or neurologic infections, and bacteria or sepsis) will be reported.
Time frame: The 14 day period following the start of treatment for an exacerbation
Percentage of participants experiencing an injection site reaction
Among participants who inject study treatment for an exacerbation, the percentage who experience injection site reactions will be reported.
Time frame: The 14 day period following the start of treatment for an exacerbation
Percentage of accurately identified participants
Electronic medical record (EMR)-based data pulls will occur at intervals throughout the enrollment period to identify potentially eligible participants through a computable phenotype. The percentage of potentially eligible participants that were accurately identified through this computable phenotype will be reported.
Time frame: Up to 24 months
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol, Sap, Icf
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University of North Carolina, Chapel Hill