[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-asthma-exacerbation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-asthma-exacerbation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100640560","phase-1-anakinra-rescue-treatment-for-moderate-asthma-attacks-artma-100640560",false,"NCT07600190","Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)","Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA) Pilot Study","ARTMA","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Age ≥18 years\n* 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.\n* Current use of controller therapy such as inhaled corticosteroid (ICS) or ICS in combination with long-acting beta agonist (LABA)\n* Asthma exacerbation requiring systemic corticosteroid therapy in the past 12 months\n* Negative pregnancy test for females who are not s\u002Fp hysterectomy with oophorectomy or who have been amenorrheic for 12 months or more.\n* Asthma Impairment and Risk Questionnaire (AIRQ) Score \\>2\n\nExclusion Criteria:\n\n* Clinical contraindications:\n\n  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.\n  2. History of undergoing bronchial thermoplasty.\n  3. Intubation for asthma in the last 12 months\n  4. History of malignancy except non-melanoma skin cancer within the last five years.\n  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.\n  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.\n  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 \\\u003C40 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\u002Ftank\u002Fpod per day for 1 year; and active use of smoking\u002Fvaping marijuana, specified as once per week in the last year.\n  8. Allergy\u002Fsensitivity to study drugs or their formulations, including latex\n  9. Unwillingness to use reliable contraception if sexually active (IUD, birth control pills\u002Fpatch, condoms).\n  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)\n* 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.\n* Usage of the following medications:\n\n  1. Use of daily systemic corticosteroid therapy for asthma control\n  2. Use of any immunomodulatory therapy within the preceding 12 months, including biologics that are approved for asthma.\n  3. Currently receiving allergen immunotherapy\n  4. Use of any immunosuppressant therapy within the preceding 12 months will be reviewed by the study physician.\n* Laboratory: Participants who meet the following criteria will be excluded from study:\n\n  1. Positive QuantiFERON-tuberculosis (TB) gold assay. Cases of indeterminate QuantiFERON-TB test results will require a second specimen to be drawn.\n  2. Baseline absolute neutrophil count (ANC) \\\u003C1.0 x 109\u002FL for participants of African descent, \\\u003C1.5 x 109\u002FL for other participants\n* Allergy\u002Fsensitivity to study drugs or their formulations, including latex.\n* History of anaphylaxis requiring epinephrine treatment\n* Inability or unwillingness of a participant to give written informed consent.\n* Inability or unwillingness to self-administer injectable medication (anakinra or placebo).","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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.",[27,28,29],"Asthma (Diagnosis)","Persistent Asthma","Moderate Asthma Exacerbation",[31,32,33,34,35,36,37,28],"Asthma","Asthma Exacerbation","Anakinra","Kineret","Interleukin-1 Receptor Antagonist","IL-1 receptor blockade","Airway Inflammation","NOT_YET_RECRUITING","2026-05-14",{"date":41,"type":42},"2026-05-20","ACTUAL",{"date":44,"type":21},"2026-06-01",{"date":46,"type":21},"2028-12-01",{"name":48,"class":49},"University of North Carolina, Chapel Hill","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":50},"100492367","early-high-flow-oxygen-therapy-with-nebulized-beta-2-agonist-using-a-vibrating-mesh-for-the-management-of-moderate-to-severe-asthma-exacerbation-in-the-emergency-department-100492367","NCT05691218","Early High-flow Oxygen Therapy With nebuLized Beta-2-agonist Using a Vibrating Mesh for the Management of Moderate to Severe Asthma Exacerbation in the Emergency Department","EOLE","Inclusion Criteria:\n\n* Age equal or over 18 years\n* admitted in an Emergency Department with a clinical suspicion of acute exacerbation of asthma according to the Global Initiative for Asthma (GINA) criteria.\n* with at least one of the following criteria 60mn after a first treatment by beta-2 agonist adrenergic nebulization with 3 x 5 mg of terbutaline:\n\n  * Respiratory rate over 22 breaths\u002Fmin\n  * Peak flow \\\u003C 50% of predictive normal value\n  * SpO2 \\\u003C 95% in room air\n  * Signs of severe asthma exacerbation (at least one criteria):\n\nTalks in word, Agitation, Sits hunched forwards, Accessory muscles in use\n\n* Free subject, without guardianship or curatorship or subordination\n* Patients benefiting from a Social Security scheme or benefiting from it through a third party\n* Informed consent signed by the patient after clear and honest information about the study\n\nExclusion Criteria:\n\n* Acute exacerbation of asthma during the last 30 days\n* Clinical suspicion of acute exacerbation of asthma due to anaphylaxis, pneumothorax, pneumomediastinum, pneumonia or atelectasis.\n* At least ONE of the following serious signs: drowsiness, confusion, auscultatory silence\n* Clinical suspicion of another pathology that could explain the respiratory failure such as heart failure, laryngeal obstruction, pulmonary embolism, etc\n* Patients with neurological (Glasgow \\\u003C 13) or hemodynamical failure (Mean Arterial Pressure \\\u003C 65 mmHg)\n* contraindication to treatment with a beta-2-adrenergic agonist\n* History of hypersensitivity (allergy) to terbutaline or any of the constituents\n* Contraindication to OHD\n* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, people assessed GIR1 or GIR 2 (AGGIR grid), adults under legal protection\n* Pregnant or breastfeeding women, Women at age to procreate and not using effective contraception",{"count":20,"type":21},[60],"NA","Acute exacerbation of asthma represents an acute or sub-acute worsening in symptoms and lung function in patients with asthma. It is characterized by a progressive increase in symptoms of shortness of breath, cough, wheezing, or chest tightness. It is a common diagnosis in patients admitted in an Emergency Department for dyspnoea. Near 10 to 15% of respiratory symptoms in an ED are related to acute exacerbation of asthma.\n\nTreatment of acute exacerbation of asthma associates nebulized beta-2 agonist adrenergic with or without ipratropium bromide, oral corticosteroids and controlled oxygen therapy to maintain SpO2 between 93 and 95%. Treatment in the ED did not vary during last years, including for patients with a lack of efficacy after first line treatment, and exacerbation are always associated with a hospitalisation in 40% of adult patients and with mortality in 1% of hospitalized patients.\n\nVibrating mesh nebulizers are devices using vibration to push drug through the mesh, resulting in the drug nebulization. Vibrating mesh nebulizers have been associated with better pulmonary drug delivery than jet-nebulizers, provide faster improvement in peak expiratory flow and have been associated in retrospective studies with patient prognosis, particularly in terms of throughput time and need for hospitalisation. However, no studies have prospectively compared nebulisation with a vibrating membrane device with standard nebulisation in patients with asthma exacerbation on clinically relevant criteria. Nebulisation with a vibrating membrane device may potentiate the clinical efficacy of short-acting bronchodilators, result in faster and more effective clinical improvement, and be associated with improved short- and medium-term patient outcomes.\n\nHigh-flow nasal cannula heated, and humidified oxygen (HNFO) is a ventilatory support which is commonly used for the management of acute respiratory failure for acute respiratory failure in intensive care units and in emergency departments. HFNO delivers high fraction of inspired oxygen (FiO2), generates a low level of positive pressure and provides washout of dead space in the upper airways, thereby improving mechanical pulmonary properties and unloading inspiratory muscles during ARF. Consequently, HFNO is associated with a decrease in the work of breathing. During asthma exacerbation, HFNO was associated with an improvement in the dyspnea level and in the respiratory rate compared with conventional oxygen therapy. However, HFNO has never been assessed in association with nebulized beta-2 adrenergic agonist.\n\nTo resume, beta-2 adrenergic agonist nebulization with a vibrating mesh nebulizer seems effective, especially compared to standard jet nebulization. In addition, HFNO is a technique that appears to be suitable for the pathophysiological conditions of chronic reversible respiratory failure, and can be used during exacerbations of asthmatic disease. The high flow rate of gas makes it possible to control the FiO2 in order to avoid hyperoxia, to generate a PEEP effect, to reduce the patient's work of breathing and the respiratory resistance, and to avoid the re-inhalation of CO2 by a dead space wash-out.\n\nIn the EOLE study, the investigators propose to compare three therapeutic management strategies. One standard strategy (nebulisation with a jet-nebulizer), and two experimental strategies (nebulisation with a vibrating mesh device, and nebulisation with a vibrating mesh device in association with HFNO).\n\nThe investigators hypothesise that bronchodilator nebulization with a vibrating mesh nebulizer is more effective than jet-nebulizers for the management of patients admitted for asthma exacerbation and non-responders or with lack to efficacy to initial treatment. Furthermore, the investigators also hypothesise that the addition of the physiological effects of HFNO may enhance the efficacy of the treatment.\n\nThe therapeutic effects of nebulisation with a vibrating membrane device alone or with the addition of the physiological effects of HFNO could constitute a new approach to the management of asthma patients, particularly in patients who are insufficiently responsive or non-respondent to initial treatment.",[29,63],"Severe Asthma Exacerbation","RECRUITING","2025-06-03",{"date":67,"type":42},"2025-06-06",{"date":69,"type":42},"2024-02-19",{"date":71,"type":21},"2026-03-19",{"name":73,"class":49},"Poitiers University Hospital"]