Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07600190
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Asthma (Diagnosis)
  • Moderate Asthma Exacerbation
  • Persistent Asthma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anakinra 100 Mg/0.67 Ml Inj Syringe — DRUG
    Active study treatment
  • Saline Placebo/0.67 Ml Inj Syringe — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Treatment
    Subjects will be randomized to receive two doses of active study treatment (anakinra) upon meeting orange zone exacerbation criteria.
  • Placebo Comparator: Placebo
    Subjects will be randomized to receive two doses of placebo upon meeting orange zone exacerbation criteria.

Primary Outcome Measure

Effect of Anakinra on percent change in Peak Expiratory Flow from baseline during moderate asthma exacerbation [ Time Frame: Day 1 of treatment through day 10 after treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina Chapel HillChapel HillNorth Carolina27599
Chris Brooks
[email protected]
919-843-6598
Corinne Taylor
[email protected]
919-962-9841
Michelle Hernandez, MD (PRINCIPAL_INVESTIGATOR)

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University of North Carolina Chapel Hill· Chapel Hill, NC

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