[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"allergic-asthma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:allergic-asthma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,59,91,115,144,167,187],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":35,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100597211","creating-a-risk-assessment-tool-for-thunderstorm-asthma-the-carista-study-100597211",false,"NCT07055542","Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study","Creating A RIsk Assessment Biomarker Tool to Prevent Seasonal and Thunderstorm Asthma: The CARISTA Study","CARISTA","Inclusion Criteria:\n\nConsenting adults aged 18 to 70 years with seasonal allergic rhinitis\n\nwilling to undertake:\n\n* Lung function testing\n* Blood sample collection for risk factor identification, -Prospectively logging their symptoms and medications through the springtime season using the CARISTA symptom monitoring platform . -\n\nExclusion Criteria:\n\n* Individuals unable to provide informed consent\n* Individuals who do not suffer from symptoms of seasonal allergic rhinitis\n* Individuals who do not consent to lung function testing and blood sample collection - Individuals with unstable asthma (FEV1 by spirometry less than 70% predicted), a recent exacerbation or change of asthma preventive medication use (within one month) would be excluded, although re-screening would be permitted after one month, time permitting.\n* Individuals with severe asthma requiring the use of continuous oral corticosteroids or biological medication for severe asthma.\n* The presence of any medical illness, such as cardiac disease, pre-existing illness or immunomodulatory therapy that, in the opinion of the Investigators, would compromise participant safety or the derivation of biomarkers during the study.",true,"ALL","18 Years","70 Years",{"count":22,"type":23},530,"ESTIMATED","INTERVENTIONAL",[26],"NA","Thunderstorm asthma is a recurring public health emergency in South-Eastern Australia which occurs in springtime. The major identified risk factors for thunderstorm asthma is hay fever and allergy to ryegrass pollen. The goal of the CARISTA study is to identify the risk of springtime allergic and thunderstorm asthma in allergic adults living in South-Eastern Australia. To do this the investigators will recruit 530 people who have hay fever and test them for allergy to ryegrass pollen and undertake simple lung function testing. The investigators will ask study participants to complete a customised symptom tracker over the springtime pollen season for 2 consecutive years. The outcome the investigators are looking for is an asthma exacerbation or worsening asthma symptoms. This study will enable the investigators to identify indicators (biomarkers) of severe and moderate asthma exacerbations in order to identify those at risk of thunderstorm and seasonal asthma so protective treatments and strategies can be advised.",[29,30,31,32,33,34],"Allergic Asthma","Thunderstorm Asthma","Seasonal Allergic Rhinitis","Grass Pollen Allergy","Asthma Exacerbation Due to Thunderstorm","Asthma Acute",[36,37,38,39,40,41,42,43,44,45],"asthma","allergy","grass pollen allergy","ryegrass pollen","prospective symptom monitoring","seasonal allergic rhinitis","hay fever","seasonal allergic rhinoconjunctivitis","serum specific IgE","spirometry","RECRUITING","2026-04-29",{"date":49,"type":50},"2026-05-06","ACTUAL",{"date":52,"type":50},"2025-08-27",{"date":54,"type":23},"2030-12-31",{"name":56,"class":57},"University of Melbourne","OTHER",6,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":24,"phases":69,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100589897","phase-1-safety-and-immunogenicity-of-cat-allergen-intralymphatic-immunotherapy-in-patients-with-cat-allergy-with-and-without-asthma-100589897","NCT06960382","Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy in Patients With Cat Allergy With and Without Asthma","Safety and Immunogenicity of Cat-allergen Intralymphatic Immunotherapy: an Open Label Phase II Study in Patients With Cat Allergy With and Without Asthma","Inclusion Criteria:\n\n* Informed consent as documented by signature.\n* Cat-dander-induced ARC as confirmed by patient history and type-1-sensitization to cat dander in skin and\u002For serum.\n\nExclusion Criteria:\n\n* Hypersensitivity to phenol.\n* Planned depot steroid injection for treatment of ARC\n* Patients with uncontrolled asthma or FEV1 \\\u003C 70% of the predicted value in adults (after adequate pharmacological therapy).\n* Patients with a severe asthma exacerbation in the past 3 months.\n* Irreversible secondary changes in the affected organ (e.g., emphysema, bronchiectasis).\n* Chronic obstructive or restrictive lung disease.\n* Patients with active systemic autoimmune diseases and patients with immune deficiencies or immune weaknesses.\n* Severe chronic inflammatory diseases.\n* Concomitant infection with fever or other signs\u002Fsymptoms of an acute or chronic infection at treatment visit.\n* Chronic obstructive or restrictive lung disease\n* Patients with malignant tumours that currently have clinical significance.\n* Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension, and treatment with beta-blockers).\n* Known cardiovascular disease, i.e., not even NYHA class I.\n* Use of ACE-blockers.\n* Recent or on-going hepatic or renal disease.\n* Severe chronic renal insufficiency (due to aluminium burden).\n* Alcohol or drug abuse\n* Women who are pregnant and breast feeding\n* Women of childbearing age who wish to become pregnant or do not use contraception.\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.\n* Participation in another study with investigational drug within the 30 days preceding and during the present study.","65 Years",{"count":68,"type":23},36,[70,71],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety and tolerability of intralymphatic immunotherapy (ILIT) with ALUTARD SQ Felis domesticus in patients with cat allergy-induced allergic rhinitis and asthma. The main questions it aims to answer are:\n\nIs ILIT with ALUTARD SQ Felis domesticus safe and well tolerated?\n\nWhat immunological responses play a role in ILIT?\n\nResearchers will compare the effects of ILIT to existing subcutaneous immunotherapy (SCIT) approaches to assess safety, tolerability, immunogenicity, and efficacy.\n\nParticipants will:\n\nReceive 3-4 ILIT injections of ALUTARD SQ Felis domesticus into an inguinal lymph node, guided by ultrasound.\n\nUndergo safety monitoring, including WAO guidelines for systemic allergic reactions and tryptase measurement.\n\nComplete lung function tests, questionnaires, and a modified nasal provocation test to evaluate asthma effects and treatment efficacy.\n\nProvide blood samples for ImmunoCAP and basophil activation testing using CAST ELISA.\n\nInclusion criteria: Adults aged 18-65 with cat-dander-induced allergic rhinitis and asthma.\n\nExclusion criteria: Hypersensitivity to treatment components, systemic steroid use, uncontrolled asthma (FEV1 \\\u003C 70%), recent severe asthma exacerbations, or serious comorbidities.\n\nThe study aims to generate data to inform future efficacy trials.",[74,29],"Allergic Rhinitis",[76,36,77,78,79,80],"cat allergy","rhinitis","immunotherapy","intralymphatic injection","ILIT","2026-03-12",{"date":83,"type":50},"2026-03-16",{"date":85,"type":50},"2025-08-20",{"date":87,"type":23},"2028-03-31",{"name":89,"class":57},"University of Zurich",1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":90},"100625669","rollyn-oma-an-observational-study-in-patients-treated-by-omlyclo-an-omalizumab-biosimilar-100625669","NCT07425639","ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar","ROLL'YN-OMA : Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Omlyclo®, un Omalizumab Biosimilaire","ROLL'YN-OMA","Inclusion Criteria:\n\n* Be an adult (aged 18 years or older at the time of inclusion) receiving specialist care and diagnosed with one of the following conditions: Severe asthma, Chronic Spontaneous Urticaria\n* Have been treated for at least 6 months prior to inclusion with the reference omalizumab for the relevant condition (Severe asthma or Chronic Spontaneous Urticaria).\n* Have been stable for at least 3 months according to the prescribing physician, with the disease controlled or in clinical remission based on the disease-specific activity score: Severe asthma: ≤ 1 course of oral corticosteroids per year related to disease worsening, without hospitalization, and ACQ \\\u003C 1.5 and FEV1 ≥ 80% of the patient's most recent values\u002F Chronic Spontaneous Urticaria : UCT ≥ 12\n* For whom the specialist physician has decided to switch to OMLYCLO® (biosimilar developed and marketed by Celltrion) on the day of patient inclusion (shared medical decision independent of the study).\n* Be able to start treatment within a maximum of 60 days following inclusion.\n* Have an email address.\n* Have a mobile phone number.\n* Be able to understand and complete questionnaires in French.\n* Not object to participating in the study.\n* Be affiliated with a French Social Security scheme or be a beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Patients under guardianship or trusteeship, or otherwise deprived of liberty.\n* Pregnant women or women of childbearing potential with a desire to become pregnant during treatment with OMLYCLO®.\n* Patients who, at the time of inclusion, are participating in a clinical trial or another clinical study that prohibits simultaneous participation in other studies.\n* Contraindication to the study products.",{"count":100,"type":23},225,"OBSERVATIONAL","ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and\u002For remission of their disease for at least 3 months and whose physician has independently decided, within the framework of a shared medical decision, to switch them to OMLYCLO®. The primary objective of this study is to evaluate the maintenance of this control and\u002For clinical remission 12 months after initiation of the biosimilar, and subsequently, patient satisfaction at 6 and 12 months.",[104,29],"Chronic Spontaneous Urticaria (CSU)","2026-02-16",{"date":107,"type":50},"2026-02-23",{"date":109,"type":50},"2025-10-02",{"date":111,"type":23},"2028-09",{"name":113,"class":114},"Celltrion HealthCare France","INDUSTRY",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":24,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":141,"locationsCount":143},"100620043","modified-shenling-baizhu-powder-for-allergic-asthma-with-spleen-deficiency-and-dampness-accumulation-syndrome-100620043","NCT07352488","Modified Shenling Baizhu Powder for Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome","Effect of Modified Shenling Baizhu Powder on Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome: A Multicenter, Randomized Controlled Trial","mSLBZP-Asthma","Inclusion Criteria:\n\n* Patients who are persistent allergic asthma.\n* Patients who meet the diagnostic criteria for the spleen deficiency and dampness accumulation syndrome.\n* Patients who are aged between 18 and 80 years.\n* Patients who voluntarily accept the treatment and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients who have chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis , active pulmonary tuberculosis, or pulmonary embolism, etc.\n* Patients who have severe cardiovascular or cerebrovascular diseases.\n* Patients who have severe liver or kidney diseases.\n* Patients who have a history of tumor.\n* Patients who have cognitive impairment or psychiatric disorders.\n* Patients who are pregnant or breastfeeding.\n* Patients who are allergic to medication(s) used.\n* Patients who participated in another clinical trial within one month prior to enrollment.","80 Years",{"count":125,"type":23},400,[26],"Allergic asthma is a common allergic disease characterized by a protracted disease course and recurrent episodes, which severely impairs patients' physical and mental health. There is a paucity of high-quality clinical evidence in the treatment of allergic asthma with traditional Chinese medicine (TCM). This study will enroll patients who are persistent allergic asthma with spleen deficiency and dampness accumulation syndrome. A multicenter, randomized, double-blind, placebo-controlled trial design is adopted. The experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation, while the control group will receive a placebo in addition to the same inhalation therapy. Both groups will undergo an 8 week of treatment followed by a 12 week of follow-up. The primary outcome is Asthma Control Test scores, and the secondary outcomes include acute exacerbations, Asthma Control Questionnaire scores, Asthma Quality of Life Questionnaire scores, pulmonary function, airway inflammatory markers, clinical symptom scores, serum inflammatory markers, immune markers, and use of controller medications.",[29],[130,131,132,133],"Allergic asthma","Modified Shenling Baizhu Powder","Spleen Deficiency and Dampness Accumulation Syndrome","Randomized controlled trial","NOT_YET_RECRUITING","2026-01-11",{"date":137,"type":50},"2026-01-20",{"date":139,"type":23},"2026-01-15",{"date":87,"type":23},{"name":142,"class":57},"Henan University of Traditional Chinese Medicine",3,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":24,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100439951","phase-2-evaluate-the-efficacy-and-safety-of-fb825-in-adult-with-allergic-asthma-100439951","NCT05008965","Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma","A Phase II Study to Evaluate the Efficacy and Safety of FB825 in Adult Patients With Moderate-to-severe Allergic Asthma","Inclusion Criteria:\n\n1. Male or females 18-75 years old.\n2. Subjects diagnosed with moderate-to-severe allergic asthma \\[Global Initiative for Asthma \\[GINA\\]; GINA, 2021) at least 12 months prior to Visit 1.\n3. Documented reversibility from historical data of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 mcg albuterol\u002Fsalbutamol (or other standard office practice) OR documented airway hyperresponsiveness (methacholine PC20 \\\u003C 8 mg\u002FmL \\[or PC20 \\\u003C 16 mg\u002FmL on ICS\\]) OR airflow variability in clinic FEV1 \\>12% and 200 mL between visits outside of respiratory infections, documented in the past 24 months prior to Visit 1 if documented reversibility and airway hyperresponsiveness data are not available.\n4. Subjects must have a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% predicted within 2 months from randomization.\n5. Subjects must have received a physician-prescribed asthma regimen with medium- or high-dose ICS plus LABA for at least 3 month prior to Visit 1 and the dose of ICS must be stable for at least 30 days prior to Visit 1 and throughout the screening period.\n\n   1. High-dose ICS is defined as total daily dose of \\>500 mcg fluticasone propionate or equivalent\n   2. Medium-dose ICS is defined as a total daily dose of 250 to 500 mcg fluticasone propionate or equivalent.\n   3. Equivalence ICS doses will be based upon the GINA guidelines (GINA, 2021)\n   4. According to the medical history, subject have no more than a maximum of 2000 mcg\u002Fday equipotent ICS daily dosage of fluticasone propionate or equivalent in 3 months before visit 1.\n6. Prior to screening, subjects must be on a stable dose of any of the following doses and formulations of ICS\u002FLABA combination therapy for at least 1 month:\n\n   1. Fluticasone\u002Fsalmeterol combination therapy\n\n      * Advair® Diskus - dry powder inhaler (DPI): 250\u002F50 μg BID or 500\u002F50 μg BID, or\n      * Advair® HFA - metered dose inhaler (MDI): 230\u002F42 μg BID or 460\u002F42 μg BID, or\n   2. Budesonide\u002Fformoterol combination therapy (Symbicort® -160\u002F4.5 μg BID or 320\u002F9 μg BID), or\n   3. Mometasone\u002Fformoterol combination therapy (Dulera® -200\u002F10 μg BID or 400\u002F10 μg BID).\n   4. Other equivalents medium to-high dose medication following the GINA guidelines (GINA, 2021)\n7. Subjects must have a documented history of protocol-defined asthma exacerbation at least 1 or more times within the 12 months.\n8. A total serum IgE ≥ 125 IU\u002FmL during screening prior to randomization.\n9. Subjects must have at least one positive in skin prick test or at least one environmental allergen-specific IgE greater than normal range.\n10. Uncontrolled asthma demonstrated both during the screening period and at the time of randomization defined as ACQ-5 (5-item Asthma Control Questionnaire) ≥ 1.5\n11. If recently treated for respiratory tract infection, the treatment must have been completed at least 4 weeks prior to screening. Subjects who have an upper respiratory tract infection during screening are allowed to be rescreened 4 weeks after resolution.\n12. Female subjects of childbearing potential must use at least two forms of birth control. One must be barrier protection (i.e., condom or female condom) and the other is one of acceptable method of birth control (ie, diaphragm, intrauterine device, hormonal contraceptives, or abstinence) throughout the study. Subjects who are surgically sterile (ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), or postmenopausal (defined as amenorrhea for 12 consecutive months and documented serum follicle stimulating hormone level \\>40 mU\u002FmL) will be considered as no childbearing potential. All female subjects of child-bearing potential must have a negative serum pregnancy test at screening.\n\n    Note: The subject must use the methods of contraception mentioned above during study period and at least 120 days after the last dosing of FB825.\n13. The subject has a body weight ≥ 40 kg at screening.\n14. The subject has a normal or non clinically significant abnormal, as determined by the investigator, 12-lead electrocardiogram (ECG).\n15. The subject is able to provide written informed consent.\n16. The subject agrees to comply with all protocol requirements.\n\nExclusion Criteria:\n\n1. Asthma exacerbation or any other reason requiring systemic steroids in the 30 days prior to randomization. Subjects are allowed to be rescreened 30 days after completion of treatment.\n2. \\>20% relative change in post-bronchodilator FEV1 between screening and randomization.\n3. Female subjects who are pregnant or lactating.\n4. A positive human immunodeficiency virus (HIV) test (e.g., HIV Ag\u002FAb combo test) at screening or subject taking antiretroviral medications, as determined by medical history.\n5. Patients with positive HBeAg or HCV RNA results should be excluded as they are indications of active Hepatitis B virus and Hepatitis C virus replication.\n6. Active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease) other than allergic asthma.\n7. Use of any experimental drug within 30 days or 5 half-lives, whichever is longer, prior to or during the screening period.\n8. Current or history of treatment with a monoclonal antibody, for example, IL-4, IL-5, IL-13 or IL-15 antibody treatment within 6 months prior to the screening.\n9. Current or history of treatment with anti-IgE antibody treatment within 6 months or 5 half-lives, whichever is longer.\n10. The subject has a history of alcohol or drug abuse that would impair or risk the patients' full participation in the study, in the opinion of the investigator.\n11. The subject has any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements.\n12. The subject has indication of severe liver disease, defined by serum levels of either alanine aminotransferase (ALT), aspartate transaminase (AST) above 3x upper limits of normal (ULN) or elevated total bilirubin \\>2x ULN as determined at screening.\n13. The subject has severe kidney disease, defined as estimated GFR \\\u003C30ml\u002Fmin\u002F1.73m2 or creatinine \\> 3x ULN.\n14. The subject has known or suspected history of immunosuppression or immunodeficiency.\n15. Known history of active tuberculosis (TB) or evidence of tuberculosis infection as defined by a positive purified protein derivative (PPD) skin test and\u002For interferon-gamma release assay. The interferon-gamma release assay should be repeated in case of an indeterminate result.\n16. The subject has history of malignancy within 5 years before the screening period. Patients with non-invasive carcinoma in-situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin may be eligible if they have undergone curative resection at least 12 months prior to screening.\n17. Current smoker with \\> 10 packs year prior to screening. A smoker is defined as a subject who has taken inhaled nicotine containing products (e.g. cigarette, cigar, pipe), including e-cigarettes prior to screening.\n18. High risk of parasite infection\n\n    • Risk factors for parasitic disease (living in an endemic area, travel within the last 6 months to regions where geohelminthic infections are endemic, and\u002For chronic immunosuppression).\n\n    AND\n\n    • Evidence of parasitic colonization or infection on stool evaluation for ova and parasites.\n\n    Note: stool ova and parasite evaluation will only be conducted in patients with risk factors and an eosinophil count more than twice the upper limit of normal.\n19. The subject has received live vaccine within 12 weeks or COVID-19 vaccination within 2 weeks prior to dosing or planned live attenuated vaccinations during the study.\n20. The subject has a history of any clinically relevant arrhythmias as determined by the investigator.\n21. The subject has a history of respiratory failure or near fatal asthma events which resulted in intensive care unit admission or intubation within five years before the screening period.\n22. History of anaphylaxis to any biologic therapy.\n23. The subject has major surgery, for example organ replacement, joint replacement, full hysterectomy, heart surgeries, within 8 weeks before the screening. The subject who has major surgery prior to 8 weeks of screening should have fully recovered from any surgical procedures.\n24. The subject has comorbid disease that might interfere with the evaluation of IMP (investigational medicinal product) or conduct of study procedures (eg, bronchodilator test).\n25. The subject requiring non-selective beta-adrenergic receptor blockers for any reason and initiation or dose change of a selective beta-1 adrenergic receptor blocker within 3 months prior to Visit 1.\n26. The subject who received bronchial thermoplasty within 3 years of Visit 1 OR patients who plan to begin therapy during the Screening Period or the Randomized Treatment Period.\n27. The subject with active autoimmune disease (excluding atopic dermatitis) or patients using immunosuppressive therapy for autoimmune disease (excluding atopic dermatitis) (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) or patients with high titer autoantibodies at screening who are suspected of having high risk for developing autoimmune disease at the discretion of the Investigator or the Sponsor.\n28. Use of Traditional Chinese Medications, those that are listed in the Prohibited Medication, for the treatment of asthma within 3 months prior to screening.\n29. Aggravating factors that are inadequately controlled e.g., medication uncontrolled gastroesophageal reflux disease.\n30. The subject has adrenal insufficiency (ACTH-resistant) by rapid ACTH stimulation test due to known history of adrenal insufficiency or being suspected of adrenal insufficiency or long-term use of systemic corticosteroids (annual average more than 6 months in the past two years).\n\n    Adrenal insufficiency: after 30 minutes of ACTH injection, the cortisol level ≦20 mg\u002Fml in rapid ACTH stimulation test.\n31. History of prior positive SARS-CoV-2 diagnostic test (antigen or NAAT\u002FPCR) within 3 months prior to screening.","75 Years",{"count":153,"type":23},100,[71],"This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy and safety of FB825 in adult patients with moderate-to-severe allergic asthma.",[29],"2026-01-09",{"date":159,"type":50},"2026-01-12",{"date":161,"type":50},"2021-07-27",{"date":163,"type":23},"2027-12",{"name":165,"class":114},"Oneness Biotech Co., Ltd.",13,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":151,"enrollmentInfo":174,"targetDuration":4,"studyType":24,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":90},"100619298","phase-2-efficacy-safety-and-pharmacokinetics-of-lp-003-injection-in-allergic-asthma-patients-100619298","NCT07342803","Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients","A Multicenter, Randomized, Double-Blind, Active Drug and Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in the Treatment of Patients With Moderate to Severe Persistent Allergic Asthma.","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 75 years, no gender restriction;\n2. Body weight ≥ 40 kg;\n3. Diagnosed with bronchial asthma for at least 1 year according to the \"Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)\", and diagnosed with allergic asthma according to the \"Chinese Guidelines for the Diagnosis and Treatment of Allergic Asthma (2019 Edition)\" ; At least 1 asthma exacerbation in the year prior to screening (referring to GINA and Chinese guidelines, asthma exacerbation is defined as worsening of asthma symptoms requiring systemic glucocorticoid treatment for at least 3 days, and\u002For multiplying the dose of inhaled glucocorticoids for at least 3 days);\n4. Positive bronchial dilation test within 24 months prior to screening or at the time of screening;\n5. Subjects with at least one positive skin prick test or positive serum specific IgE test result for a relevant allergen within 12 months prior to randomization;\n6. Subjects who have received medium to high dose inhaled corticosteroids (ICS) treatment for at least 8 weeks prior to screening (fluticasone propionate \\>250 μg\u002Fday or equivalent dose of ICS, not exceeding fluticasone propionate 2000 μg\u002Fday or equivalent dose of ICS, as per the \"Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)\"), have maintained stable use for 4 weeks before randomization, with asthma remaining partially controlled or uncontrolled (defined as ACT score ≤ 19);\n7. Combined with at least one other asthma control medication (long-acting β2 receptor agonists (LABA), long-acting muscarinic antagonists (LAMA), leukotriene receptor antagonists (LTRA), and sustained-release theophylline treatment) and stable use for 4 weeks before randomization ;\n8. At screening, 40% \\\u003C FEV1 \\\u003C 80% of predicted value;\n9. Subjects who have no plans for pregnancy and agree to take effective contraceptive measures during the trial and for 6 months after the last dose of study treatment;\n10. Subjects who voluntarily sign the ICF, are able to understand and correctly fill out the assessment form, correctly use the PEF device and record the patient diary card, and attend follow-up visits as scheduled.Male or female, aged 18 to 75 years.\n\nExclusion Criteria:\n\n1. Allergic to the investigational product and its excipients or Xolair® ;\n2. Coexisting diseases other than asthma that may affect lung function, such as chronic obstructive pulmonary disease (COPD), allergic bronchopulmonary aspergillosis (ABPA), and bronchiectasis, which, in the investigator's judgment, may place the subject at inappropriate risk or affect the assessment of study results;\n3. Patients who have severe or uncontrolled diseases of the liver, kidneys, gastrointestinal tract, cardiovascular and cerebrovascular systems, hematopoietic system, urogenital system, endocrine system, nervous system, immune system, etc.;\n4. Clinically significant infection history within 4 weeks prior to randomization, as assessed by the investigator, affecting patient evaluation;\n5. Major surgery within 4 weeks prior to randomization or planned surgical procedures during the study period, or treatments that the investigator believes may affect patient evaluation;\n6. Known parasitic infection within 6 months prior to randomization;\n7. History of malignancy diagnosed within 5 years prior to screening;\n8. Clinically significant abnormalities in laboratory tests during the screening period and baseline, deemed unsuitable for participation by the investigator ;\n9. Positive test for human immunodeficiency virus (HIV) antibodies at screening, or positive for treponema pallidum antibodies (except RPR or TRUST negative), or positive for hepatitis B surface antigen (except HBV-DNA below the detection limit of the site), or positive for hepatitis B core antibody (except HBV-DNA below the detection limit of the site), or positive for hepatitis C virus (HCV) antibodies (except HCV RNA below the detection limit of the site);\n10. Still smoking or having quit smoking for less than 6 months at screening, or a history of smoking ≥10 pack-years \\[Smoking Index (pack-years) = daily smoking amount (packs) × smoking duration (years), 1 pack = 20 cigarettes\\];\n11. Used biological agents such as monoclonal antibodies, including investigational biological agents, within 3 months prior to screening or within 5 half-lives of the drug (whichever is longer);\n12. Received systemic immunosuppressants or systemic glucocorticoids (dose equivalent to prednisone \\>10 mg\u002Fday) for inflammatory or autoimmune diseases (such as rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, etc.) within 8 weeks prior to screening or within 5 half-lives of the drug (whichever is longer);\n13. Specific allergen immunotherapy conducted within 3 months prior to screening;\n14. Live (attenuated) virus\u002Fbacterial vaccines administered or intravenous immunoglobulin used within 4 weeks prior to screening;\n15. Participation in other drug clinical trials within 3 months or 5 half-lives of the drug (whichever is longer) prior to screening;\n16. History of drug abuse, substance abuse, and\u002For excessive alcohol consumption within 1 year prior to screening;\n17. Pregnant or breastfeeding women;\n18. Any other condition that makes the subject unsuitable for participation in the trial as assessed by the investigator.",{"count":175,"type":23},200,[71],"This is a multicenter, randomized, masked, active and placebo controlled, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-003 injection in adult patients with moderate to severe persistent allergic asthma.",[29],"2026-01-05",{"date":139,"type":50},{"date":182,"type":50},"2025-01-25",{"date":184,"type":23},"2029-09-30",{"name":186,"class":114},"Longbio Pharma",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":18,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":24,"phases":199,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":90},"100488527","phase-2-clinical-trial-to-evaluate-the-efficacy-and-safety-of-polymerized-mannan-conjugated-dermatophagoides-allergen-extract-100488527","NCT05641272","Clinical Trial to Evaluate the Efficacy and Safety of Polymerized, Mannan-Conjugated Dermatophagoides Allergen Extract","Prospective, Randomised, DBPC Clinical Trial to Evaluate the Efficacy and Safety of Polymerized and Mannan Conjugated Allergen Extract of Dermatophagoides for the Treatment of Allergic Rhinitis\u002FRhinoconjunctivitis With or Without Asthma","MM09-SLIM","Inclusion Criteria:\n\n1. Signed Informed Consent Form.\n2. Male or female, aged between 12 and 60 years, both included.\n3. Confirmed clinical history of inhalation allergy with moderate-severe rhinitis\u002Frhinoconjunctivitis according to the ARIA classification with or without controlled mild-moderate intermittent or persistent asthma according to the definition of GEMA 5.0 y GINA caused by allergy to mites (D. pteronyssinus and\u002For D. farinae). The asthma diagnostic will be valid up to 24 months prior to signing the informed consent form.\n4. Combined Symptom and Medication Score for moderate to severe rhinitis\u002Frhinoconjunctivitis (RCSMS) ≥ 1,8 out of 3.\n5. Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and\u002For Dermatophagoides farinae. The results will be valid up to 12 months prior to signing the informed consent form.\n6. Specific IgE against a complete extract of Dermatophagoides pteronyssinus and\u002For D. farinae or any the molecular components of allergenic sources with a value ≥ 3.5 kU\u002FL. The results will be valid up to 12 months prior to signing the informed consent form.\n7. Subjects shall preferably be monosensitised to the study allergens. In case of subjects sensitised to other aeroallergens, only those with the following characteristics may be included in the study (results will be valid up to 12 months prior to signing the informed consent form):\n\n   * Subjects with a positive skin prick test to Blomia tropicalis and Lepidoglyphus destructor, whose wheal major diameter and specific IgE values do not exceed or equal the values for the study allergens.\n   * Subjects with a positive skin prick test for dander if they have occasional exposure and symptoms.\n   * Subjects with positive skin prick test to pollens, whose specific IgE values do not exceed or equal the values for the study allergens and who also do not have exacerbations during pollen season. The maximum specific IgE value to theses allergens is 17.5 kU\u002FL.\n8. Subjects with negative skin prick test to mold. In case specific IgE determination have been performed, the result must be \\\u003C0.35 kU\u002FL.\n9. Women of childbearing age (since menarche) must present a negative urine pregnancy test at the time of trial enrollment.\n10. Women of childbearing age must commit to using and adequate contraception method.\n11. Subjects capable of complying with a dosage regimen.\n12. Subjects owning a smartphone to register symptoms and medication consumption.\n\nExclusion Criteria:\n\n1. Subjects polysensitized to other aeroallergens with clinically relevant symptoms.\n2. Subjects who have received previous immunotherapy in the preceding 5 years to any of the tested allergens or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.\n3. Patients in whom immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee may not be included.\n4. Subjects with uncontrolled severe asthma, and\u002For with FEV1 \\\u003C80% of baseline despite adequate pharmacological treatment by the time of the enrolment.\n5. Subjects on treatment with ß-blockers.\n6. Subjects on treatment with immunosuppressive or biological drugs.\n7. Subjects who are unstable by the time of enrolment (respiratory infection, febrile process, acute pruritus, etc.).\n8. Subjects with chronic urticaria during the last 2 years, severe anaphylaxis or with hereditary angioedema history.\n9. Subjects with any pathology in which the administration of adrenaline is contraindicating (hyperthyroidism, hypertension, heart disease, etc.) according to the investigator discretion.\n10. Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that could interfere with treatment and follow-up (epilepsy, psychomotor disorders, diabetes, malformations, multi-surgery, nephropathy, etc.), according to the investigator discretion.\n11. Subjects with severe autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies.\n12. Subject whose condition prevents him\u002Fher from offering cooperation and\u002For who presents severe psychiatric disorders, according to the investigator discretion.\n13. Subjects with known allergy to the other components of the investigational product other than allergen study.\n14. Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis.\n15. Pregnant or breastfeeding women.\n16. Subjects who are immediate family members of researchers.\n17. Concurrent participation in other clinical trials or previous participation within 30 days prior to inclusion.\n18. History of severe systemic reactions, including food, hymenoptera venom, etc.\n19. Subjects who have suffered a respiratory tract infection and\u002For asthma exacerbation within 4 weeks prior to screening.\n20. Subjects with a history of significant renal disease or chronic liver disease.","12 Years","60 Years",{"count":198,"type":23},90,[71,200],"PHASE3","Prospective, randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of polymerized and mannan conjugated allergen extract of Dermatophagoides for the treatment of allergic rhinitis\u002Frhinoconjunctivitis with or without asthma.\n\nThe main objective of the clinical trial is to evaluate the clinical efficacy of the investigational medicinal product, administered sublingually, compared to placebo for the treatment of moderate-severe rhinitis\u002Frhinoconjunctivitis with or without mild to moderate asthma and controlled using the Rhinitis\u002FRhinoconjunctivitis Combined Symptom and Medication Score (R-CSMS).",[74,29,203,204],"Allergic Rhinoconjunctivitis","Allergy to House Dust Mite",[206,207,208,209,210],"Allergy","Mites","Hypersensitivity","Rhinitis","Rhinoconjunctivitis","2023-10-20",{"date":213,"type":50},"2023-10-23",{"date":215,"type":23},"2023-11-01",{"date":217,"type":23},"2026-12-01",{"name":219,"class":114},"Inmunotek S.L."]