Not yet recruitingPhase 1

Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)

Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA) Pilot Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether anakinra can be studied as an at-home rescue treatment for moderate asthma attacks. It is for adults with ongoing asthma who are at high risk for another attack. Over 26 weeks, participants will use anakinra or a placebo (a treatment with no active drug) during their first moderate attack.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Sign a form agreeing to join the study.
  • Have a doctor's diagnosis of ongoing asthma, or symptoms that meet asthma guidelines.
  • Use an asthma control medicine, such as an inhaled steroid.
  • Have had an asthma attack in the past year that needed steroid pills or shots.
  • Have a score above 2 on the Asthma Impairment and Risk Questionnaire.
  • Have a negative pregnancy test if required by the study.

Who can't join

  • Have another long-term lung disease, a past heat treatment to open the airways, or needed a breathing tube for asthma in the past year.
  • Have a cancer history within the past 5 years, except non-melanoma skin cancer; another health problem the study doctor considers unsafe; or mental health or substance use problems that could prevent following study rules.
  • Smoked more than once a week in the past year, or smoked or vaped marijuana weekly. Past tobacco use limits also apply: 15 pack-years if age 40 or older, or 10 if younger. One pack-year means one pack of cigarettes daily for one year; other smoking and vaping products also count.
  • Are pregnant, planning pregnancy, or breastfeeding, or will not follow the study's birth control rules through at least one week after the study ends.
  • Take daily steroid pills or shots for asthma, used medicines that change immune system activity in the past year, or currently get allergy treatment to build tolerance. Medicines that weaken the immune system need study doctor review.
  • Have a positive tuberculosis (TB) blood test or too few neutrophils, a type of white blood cell. The blood cell limit depends on ancestry.
  • Are allergic to the study drugs, their ingredients, or latex; or have had a severe allergic reaction that needed epinephrine.
  • Recently received treatment in another study, cannot or will not give written consent, or cannot or will not give yourself study medicine shots.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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).

Study sites (1)

NC