[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"allergic-rhinoconjunctivitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:allergic-rhinoconjunctivitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100575894","phase-4-evaluation-of-the-efficacy-of-allergen-specific-immunotherapy-using-assessment-in-an-allergen-exposure-chamber-a-randomized-placebo-controlled-double-blind-study-100575894",false,"NCT06778213","Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study","A Randomized Placebo-controlled Double-blind Clinical Study for Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Clinical and Biomarker Assessment in an Allergen Exposure Chamber and During Natural Exposure in Patients With House Dust Mite-triggered Allergic Rhinoconjunctivitis RANSES","RANSES","Inclusion Criteria:\n\nTo be eligible for trial participation, patients must meet all the following inclusion criteria:\n\n1. Written informed consent given from patient according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient)\n2. Legally competent male or female outpatient between 18 and ≤ 65 years\n3. IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by HDM allergens documented by\n\n   Positive Skin prick test (SPT) result to D. pteronyssinus allergens:\n\n   D. pteronyssinus test solution (wheal diameter) ≥ 3 mm and Positive histamine-control reaction (wheal diameter) ≥ 3 mm and Negative NaCl-control reaction (wheal diameter) \\\u003C 2 mm Immunoassay result for specific IgE ≥ 0.70 kU\u002FL to D. pteronyssinus\n4. Symptoms of rhinitis or rhinoconjunctivitis e.g., during the months October to February or over the entire year for at least 2 years before enrolment.\n5. Assessment of persistent, moderate-severe rhinitis acc. to ARIA guidelines (Brozek et al.\n\n2017, Bousquet et al. 2001) Symptoms for 4 or more consecutive weeks in the previous years and for at least 4 days per week during those weeks More than one of the symptoms evaluated as \"troublesome\" by the patients and\u002For impairing their daily activities, leisure or sport, school, or work and\u002For involving sleep disturbance 6. Symptoms requiring regular intake of anti-symptomatic medication 7. Previous symptomatic anti-allergic medication for at least 2 seasons prior to enrolment 8. At entry to this trial: No diagnosis of bronchial asthma in medical history or confirmed diagnosis of asthma as being \"well controlled\" according to GINA recommendation (GINA 2022)\n\nExclusion Criteria:\n\nGeneral criteria:\n\n1. Patients are unable to understand and comply with the requirements of the trial, as judged by the investigator\n2. Currently participating in another clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial\n3. Low adherence to trial procedures expected or inability to understand instructions\u002Ftrial documents\n4. Involvement in the planning and conduct of the trial\n5. Any relationship of dependence with the investigator\n6. Previous randomization to treatment in the present trial\n7. Mentally disabled\n8. Institutionalized due to an official or judicial order For female patients with childbearing potential (i.e., females who are not chemically or surgically sterilized or females who are not post-menopausal)\n9. Positive urine pregnancy test or pregnant\n10. Wish to become pregnant during the course of the trial\n11. Not using highly effective and reliable contraception, as judged by the investigator (reliable and highly effective methods of birth control defined as a failure rate of less than 1% per year \\[CTFG recommendations 2020\\]) during the trial. Sexual abstinence is an allowed method of birth control (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.) Males are not required to use any contraception during the study.\n12. Wish to breastfeed or breastfeeding\n\n    Immunotherapy criteria:\n13. History of a confirmed anaphylaxis after an AIT injection\n14. Current treatment with any kind of AIT\n15. AIT with HDM allergoids or allergens within the last 5 years\n16. AIT with unknown allergen within the last 5 years Sensitization criteria\n17. Clinically relevant symptoms to perennial and seasonal allergens which interfere with the assessment period of October to January. Exceptions are symptoms to allergens of cat and dog, if the patient has no direct contact to these animals.\n\n    Diseases and health status:\n18. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy\n19. Chronic persistent rhinitis symptoms for 20 years or longer\n20. Forced expiratory volume in 1 second (FEV1) \\\u003C 70 % of predicted normal values according to Quanjer (Quanjer et al. 2012) under adequate asthma treatment according to GINA recommendation (GINA 2022)\n21. Uncontrolled or partly controlled asthma according to GINA recommendation (GINA 2022)\n22. Asthma exacerbation within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency unit visit requiring the use of systemic corticosteroids or change of controller medication\n23. Severe acute or chronic diseases (e.g., COVID-19, chronic urticaria, mastocytosis, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)\n24. Autoimmune diseases, immune defects including immunosuppression, immune-complexinduced immunopathies (e.g., HIV, post-transplant patients, lupus erythematodes \\[SLE\\], vitiligo, Grave's disease, multiple sclerosis)\n25. Severe psychiatric and psychological disorders including impairment of cooperation (e.g., alcohol or drug abuse)\n26. Recurrent seizures (e.g., febrile convulsion, untreated epilepsy)\n27. Irreversible secondary alterations of the reactive organ (e.g., emphysema, bronchiectasis)\n28. For assessment the normal reference ranges of the central laboratory should be applied. If out of range, laboratory values greater than grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) will lead to exclusion of the patient.\n\n    Medications:\n29. Use of β-blockers (locally or systemically) and\u002For angiotensin-converting enzyme (ACE) inhibitors\n30. Contraindication for use of adrenalin (e.g., acute, or chronic symptomatic coronary heart disease, severe hypertension)\n31. Completion or ongoing treatment with anti-IgE-antibodies (e.g., omalizumab) or anti IL4\u002FIL13 antibodies (e.g., dupilumab) or other biological medication interfering with the TH2 pathway\n32. Completed or ongoing long-term treatment with tranquilizer or other psychoactive drugs","ALL","18 Years","65 Years",{"count":21,"type":22},67,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The main objective of the study is to measure and correlate clinical parameters suitable for the assessment of allergen immunotherapy (AIT) with an aluminum hydroxide-adsorbed preparation of house dust mite (Dermatophagoides pteronyssinus\u002F Dermatophagoides farinae) allergens in adults with moderate to severe allergic rhinitis\u002Frhinoconjunctivitis with or without controlled allergic bronchial asthma caused by house dust mite (HDM) allergens. The assessment of clinical responses will be evaluated following an allergen challenge in allergen exposure chamber (AEC) before and during the course of AIT. Patients' response to therapy will be evaluated as well as in the AEC and by patient's personal environment (Diary).",[28],"Allergic Rhinoconjunctivitis",[30,31,32,33,34],"allergen-specific immunotherapy","biomarker assessment","allergen exposure chamber","house dust mite","allergic rhinoconjunctivitis","RECRUITING","2025-01-23",{"date":38,"type":39},"2025-01-28","ACTUAL",{"date":41,"type":39},"2024-11-02",{"date":43,"type":22},"2026-12-01",{"name":45,"class":46},"Wroclaw Medical University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":81,"locationsCount":47},"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":59,"type":22},90,[61,62],"PHASE2","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).",[65,66,28,67],"Allergic Rhinitis","Allergic Asthma","Allergy to House Dust Mite",[69,70,71,72,73],"Allergy","Mites","Hypersensitivity","Rhinitis","Rhinoconjunctivitis","NOT_YET_RECRUITING","2023-10-20",{"date":77,"type":39},"2023-10-23",{"date":79,"type":22},"2023-11-01",{"date":43,"type":22},{"name":82,"class":83},"Inmunotek S.L.","INDUSTRY"]