Could an arthritis drug stop asthma attacks in their tracks?
NCT ID NCT07600190
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This pilot study tests whether anakinra, a drug that reduces inflammation, can help people with moderate asthma attacks. 60 adults at high risk for asthma attacks will either receive anakinra or a placebo at home when they feel an attack starting. The study will check if this approach is practical and if it improves breathing, to inform a larger future trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anakinra (a drug that reduces inflammation)
- What this could lead to
- If it works, this could point toward a new rescue treatment for moderate asthma attacks that people can use at home.
- What could go wrong
- This is a very early, small pilot study (Phase 1) with only 60 people. It is designed mainly to test feasibility, not yet to prove effectiveness. The drug may not work better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 amenorrheic for 12 months or more. * Asthma Impairment and Risk Questionnaire (AIRQ) Score \>2 Exclusion Criteria: * Clinical contraindications: 1. Physician diagnosis of other chronic pulmonary disease including cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema or congenital disorders of the lungs or airways. 2. History of undergoing bronchial thermoplasty. 3. Intubation for asthma in the last 12 months 4. History of malignancy except non-melanoma skin cancer within the last five years. 5. Any chronic medical condition considered by the PI as a contraindication to inclusion in the study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic or recurrent infections or immunodeficiency. 6. Mental illness or history of substance abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements. 7. History of smoking: i. Smoking \>1 time per week in the past year; ii. If ≥40 years old: Smoked ≥15 pack years; iii. If \<40 years old: Smoked ≥10 pack years; iv. Smoking equivalents of 1 pack cigarettes a day for 1 year: 1 cigar or pipe daily for 1 year; Hookah - 1 session per day for 1 year; E-cigarettes or vapes - 1 cartridge/tank/pod per day for 1 year; and active use of smoking/vaping marijuana, specified as once per week in the last year. 8. Allergy/sensitivity to study drugs or their formulations, including latex 9. Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch, condoms). 10. Current participation in an interventional trial in which study administration was administered within the past 60 days or within 5 half-lives of the drug (whichever is greater) * Pregnancy, plans to get pregnant or nursing a baby. Female volunteers will be asked to use effective birth control (stable regimen of hormonal contraceptive use for at least 6 months, intrauterine device placement, or tubal ligation for at least 6 months through at least one week after study completion) and will provide a urine sample to test for pregnancy on study days. If the test is positive or the participant has reason to believe she may be pregnant, she will be dismissed from the study. Women who have been amenorrheic for 12 months may participate. Male volunteers will be asked to use condoms for the duration of the study through at least one week after study completion. * Usage of the following medications: 1. Use of daily systemic corticosteroid therapy for asthma control 2. Use of any immunomodulatory therapy within the preceding 12 months, including biologics that are approved for asthma. 3. Currently receiving allergen immunotherapy 4. Use of any immunosuppressant therapy within the preceding 12 months will be reviewed by the study physician. * Laboratory: Participants who meet the following criteria will be excluded from study: 1. Positive QuantiFERON-tuberculosis (TB) gold assay. Cases of indeterminate QuantiFERON-TB test results will require a second specimen to be drawn. 2. Baseline absolute neutrophil count (ANC) \<1.0 x 109/L for participants of African descent, \<1.5 x 109/L for other participants * Allergy/sensitivity to study drugs or their formulations, including latex. * History of anaphylaxis requiring epinephrine treatment * Inability or unwillingness of a participant to give written informed consent. * Inability or unwillingness to self-administer injectable medication (anakinra or placebo).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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Other studies related to the condition(s) this trial covers.
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