[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Inmunotek S.L.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":259},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,56,88,117,139,159,189,210,230],{"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":30,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100619721","phase-3-efficacy-and-safety-of-slit-in-patients-with-rhinitisrc-withwithout-mild-moderate-asthma-due-to-dpt-andor-df-100619721",false,"NCT07348302","Efficacy and Safety of SLIT in Patients With Rhinitis\u002FRC With\u002FWithout Mild-moderate Asthma, Due to Dpt and\u002For Df","Prospective, Randomised, DBPC, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy in Patients With Rhinitis\u002FRhinoconjunctivitis With or Without Mild to Moderate Asthma, Allergic to Dpt and\u002For Df","Oraltek-58","Inclusion Criteria:\n\n1. Participants who have signed and dated Informed Consent Form (ICF).\n2. Female or male aged 12 to 65 years, both included, at the time of signature of ICF.\n3. Participants with confirmed clinical history of inhalation allergy with intermittent or persistent moderate-severe rhinitis\u002F rhinoconjunctivitis according to the ARIA classification(1) of at least 1 year of duration (treated with anti-allergic medication) with or without mild-moderate controlled intermittent or persistent asthma according to the definition of GINA 2022(2) caused by Dermatophagoides pteronyssinus and\u002For Dermatophagoides farinae.\n4. Participants with positive skin prick test and a wheal major diameter ≥ 5 mm to a standardized allergen extract of Dermatophagoides pteronyssinus and\u002For Dermatophagoides farinae.\n5. Women of childbearing age (i.e., following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilisation methods, such as hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a serum pregnancy test negative result, and a confirmed menstrual period before enrolling the study.\n6. Women of childbearing age must commit to using a highly effective contraception method during the trial and up to 1 month after the end of treatment with the investigational medicinal product (IMP). Such methods include: combined (estrogen and progestogen containing) hormonal, contraception. associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, male condom, diaphragm used with spermicide, bilateral tubal occlusion, vasectomized partner or sexual abstinence.\n7. Participants capable of complying with dosage regimen.\n8. Participants owning a smartphone to register symptoms and medication consumption.\n9. Participants not sensitized to any other clinically relevant allergen or sensitized with the following characteristics (sensitization to other allergens will be assessed through skin prick test in Europe and LATAM and through IgE levels in China):\n\n   1. Participants sensitized to dander (with a positive skin prick test for dander or IgE ≥ 0.35 kU\u002FL), provided that they have occasional exposure and symptoms.\n   2. Participants sensitized to endemic pollen (with a positive skin prick test or IgE ≥0.35 kU\u002FL) will be scheduled to be included so that the pollen season does not coincide with the Baseline Evaluation Period nor with one month before and after the Main Evaluation Period. In LATAM, grass sensitized participants will not be included.\n10. Participants not sensitized to moulds, cockroach, Blomia tropicalis or other geographically relevant mites (negative skin prick test or IgE \\\u003C 0.7 kU\u002FL).\n11. Participants with a RCSMS ≥ 3 out of 6 recorded for at least 10 days during the baseline evaluation period, corresponding to moderate-to-severe allergic rhinitis\u002Frhinoconjunctivitis.\n12. Participants with specific IgE against a complete extract of D. pteronyssinus and \u002F or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5kU\u002FL.\n\nExclusion Criteria:\n\n1. Participants who have received previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (e.g., oral immunotherapy \\[OIT\\], milk, or egg) before the second screening visit (S2), or currently receiving immunotherapy with any other allergen.\n2. Those cases in which allergen-specific immunotherapy (AIT) would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.(3)\n3. Asthmatic participants with forced expiratory volume in the first second (FEV1) \\\u003C80% (following at least a 6-hour washout of short-acting beta2 agonists \\[SABA\\] and 12-hour washout of long-acting beta2 agonists \\[LABA\\]) despite pharmacological treatment by the time of enrolment.\n4. Participants with uncontrolled asthma, according to GINA 2022,(2) asthma with poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma) and\u002For frequent exacerbations (≥2\u002Fyear) requiring oral corticosteroids (OCS), or serious exacerbations (≥1\u002Fyear) requiring hospitalization.\n5. Participants with severe asthma, according to GINA 2022,(2) on Step 4 or 5 treatment, who had poor symptom control and had good adherence and inhaler technique.\n6. Participants on treatment with β-blockers or angiotensin-converting enzyme (ACE) inhibitor.\n7. Participants on treatment with immunosuppressive or biological drugs.\n8. Participants who had not had a long enough washout\u002Fwithdrawal period at the first screening visit (S1) according to criteria in the study protocol (See Table 6 in section 9.5.3) before undergoing allergen diagnostic tests (skin prick test or IgE analysis).\n9. Unstable participants who have suffered a respiratory tract infection and\u002For asthma exacerbation within 4 weeks prior to first screening visit (S1).\n10. Participants who have suffered chronic urticaria, severe anaphylaxis, or with hereditary angioedema history within 2 years prior to the first screening visit (S1).\n11. Participants having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator's criteria.\n12. Participants with other severe diseases not related to allergic rhinitis or asthma that could interfere with the study treatment or the follow-up.\n13. Participants with severe and unresponsive to treatment autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases or immunodeficiencies.\n14. Participants that could not comply with the study protocol, according to the investigator's criteria, or have a serious mental illness.\n15. Participants with known allergy to any of the components of the study treatment other than study allergens.\n16. Participants who had a complication(s) of any nasal disease (including nasal polyp, nasal septal deviation, and hypertrophic rhinitis, drug-induced rhinitis and\u002For non-allergic rhinitis) affecting an appropriate evaluation of the efficacy and\u002For safety, according to investigator's criteria.\n17. Participants who had a nasal surgery within 6 months prior to the first screening visit (S1) or have programmed or anticipated nasal surgery during the trial period.\n18. Participants with a lesion in the oral cavity that could confound the safety profile of the study treatment, according to the investigator's criteria.\n19. Participants who required treatment with antihistamines and\u002For corticosteroids for other purposes than alleviating symptoms of allergic rhinitis (except temporal use for diseases such as common colds).\n20. Participants with lower respiratory tract diseases different from asthma as emphysema, bronchiectasis, or chronic obstructive pulmonary disease.\n21. Breastfeeding or pregnant women.\n22. Participants who are immediate family members of the investigator.\n23. Concurrent participation in other clinical trials or previous participation within 30 days prior to the first screening visit (S1).\n24. Participants with history of serious systemic reactions, including food, Hymenoptera venom, medications, etc.\n25. Participants expected to have marked changes (e.g., moving) in the circumstances of life during the study.\n26. Participants who plan to start using anti-mite bedding or similar equipment during the study.\n27. Participants who are considered inappropriate for the study, according to the investigator criteria.","ALL","12 Years","65 Years",{"count":21,"type":22},736,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this clinical trial is to learn if MM09 works to treat patients allergic to house mites, displaying rhinitis\u002Frhinoconjunctivitis with or without mild to moderate asthma. It will also learn about the safety of MM09. The main questions it aims to answer are:\n\nDoes MM09 reduce the symptoms and the need of rescue medication? What medical problems do participants have when inhaling MM09? Researchers will compare MM09 to a placebo (a look-alike substance that contains no drug) to see if MM09 works to treat rhinitis\u002Frhinoconjunctivitis.",[28,29],"Rhinitis","Rhinoconjunctivitis",[31,32,33,34,35,36,37,38,39,40,41,42],"immunotherapy","sublingual","Quality of live","dust mites","Dermatophagoides pteronyssinus","Dermatophagoides farinae","moderate asthma","allergic rhinitis","Allergic asthma","House dust mite allergy","efficacy","safety","RECRUITING","2026-01-09",{"date":46,"type":47},"2026-01-16","ACTUAL",{"date":49,"type":47},"2025-04-02",{"date":51,"type":22},"2029-07",{"name":53,"class":54},"Inmunotek S.L.","INDUSTRY",19,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100608005","determination-of-blomia-tropicalis-allergen-extract-in-prick-test-units-100608005","NCT07195929","Determination of Blomia Tropicalis Allergen Extract in Prick Test Units","Blomia Tropicalis Allergen Extract. Determination of the Vivo Histamine Equivalent Prick Test Units","Inclusion Criteria:\n\n1. Female or male aged 18 to 64 years, both included.\n2. Subjects who have signed and dated the informed consent form.\n3. Subjects must reside in a geographical area where allergic problems caused by Blomia tropicalis are relevant.\n4. Positive medical history of inhalant allergy (rhinitis and\u002For rhinoconjunctivitis and\u002For asthma) to Blomia tropicalis\n5. A positive prick-test (mean wheal diameter ≥ 3 mm) with an extract of the same allergen and\u002For presence of specific IgE against complete extract or any molecular component to the allergenic source.\n6. The area of the wheal obtained with 10 mg\u002FmL histamine dihydrochloride should be ≥ 7 mm², which corresponds to a mean wheal diameter ≥ 3 mm.\n7. The area of the wheal obtained with negative control should be \\\u003C 7 mm², which corresponds to a mean wheal diameter \\\u003C 3 mm.\n8. Women of childbearing age (i.e following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilization methods, such as hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must present a negative urine pregnancy test at the time of enrollment in the trial, as well as a confirmed menstrual period.\n9. Women of childbearing age must commit to using a highly effective and adequate contraception method during the trial and up to 72 hours after the end of treatment with the investigational medicinal product. Such methods include combined (estrogen and progestogen containing) hormonal; contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence.\n\nExclusion Criteria:\n\n1. Subjects outside the age range.\n2. Subjects who have previously received immunotherapy within the last 5 years for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Blomia tropicalis extract.\n3. Subjects with significant symptoms of rhinoconjunctivitis and\u002For bronchial asthma in whom discontinuation of systemic antihistamine treatment is contraindicated.\n4. Subjects who have previously exhibited a severe adverse reaction during diagnostic skin prick tests.\n5. Subjects on treatment with ß-blockers.\n6. Use of drugs that could interfere with skin prick test reactions (e.g., antihistamines) (See Section 5.2).\n7. Clinically unstable subjects (acute asthma, febrile, etc.).\n8. Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).\n9. Subjects with active herpes simplex viral infection, or herpes varicella zoster in the area where the prick test is performed.\n10. Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).\n11. States in which the subject is unable to offer cooperation and severe psychiatric disorders.\n12. Pregnant or potentially pregnant women and breastfeeding women.\n13. Subjects with known phenol allergy.","18 Years","64 Years",{"count":66,"type":22},30,[68],"NA","The primary objective is to assess the concentration of Blomia tropicalis allergenic extract that induces a wheal of size equivalent to that produced by a 10 mg\u002FmL histamine dihydrochloride solution, in order to be used as in-house reference preparation (IHRP).",[71,72],"Allergic Reactions","Allergic Skin Reaction",[74,75,76,77],"Allergy","In-House Reference Preparation (IHRP)","Prick test","Blomia tropicalis","NOT_YET_RECRUITING","2025-09-29",{"date":81,"type":47},"2025-10-02",{"date":83,"type":22},"2025-11",{"date":85,"type":22},"2027-01",{"name":53,"class":54},1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100431453","phase-3-efficacy-and-safety-evaluation-of-the-treatment-of-allergy-against-cupressaceae-and-grasses-100431453","NCT04898283","Efficacy and Safety Evaluation of the Treatment of Allergy Against Cupressaceae and Grasses.","Prospective, Multicentre, Doubleblind, Placebo-controlled RCT to Evaluate Efficacy and Safety With SC Immunotherapy in Patients With Rhinitis\u002FRhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitised to Grasses and Cupressaceae","Inclusion Criteria:\n\n1. Written informed consent.\n2. Aged between 12 and 65, both genders\n3. Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis \u002Frhinoconjunctivitis according to ARIA classification, with or without moderate intermittent or persistent asthma,according to GEMA 5.0, due to grass and cupressaceae pollen.\n4. Subjects with a positive skin prick-test (wheal size \\>5 mm diameter) to a standardized mixed extract of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne) or to one of the molecular components of the mixture and to a cupressaceae extract. In addition, the largest diameter of the papules must be greater than or equal to that of the histamine.\n5. Specific IgE \\> 3,5 KU\u002FL , against grass (preferably Phleum pratense) and cupressaceae pollen (InmunoCAP® o Immulite).\n6. Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial.\n7. Women of childbearing potential participating in the trial, should commit to using an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months in advance, surgical sterilization (for example, tubal ligation), barrier methods, or the use of oral contraceptives.\n8. Subjects capable of complying with the dosing regimen.\n9. Subjects who own a smartphone for symptom registration and medication.\n10. Subjects with a negative prick test to coestational pollens. In the case specific IgE is available, the result should be \\\u003C3,5 kU\u002FL and without relevant symptomatology\n11. Subjects with a negative prick test to other aeroallergens (dust mites, epitheliums and fungus). In the case specific IgE is available, the result should be \\\u003C3,5 kU\u002FL and without relevant symptomatology.\n\nExclusion Criteria:\n\n1. Subjects with positive prick test to other aeroallergens except for sensitisation to epithelia with occasional exposure and symptoms.\n2. Subjects with positive prick test to other aeroallergens except for sensitisation to pollen noncoseasonal with cupressus or grasses.\n3. Subjects who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.\n4. Subjects in which 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.\n5. Subjects with severe or uncontrolled intermittent or persistent asthma, with an FEV1 \\\u003C70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis \u002F rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated.\n6. Subjects who have previously had a severe secondary reaction during the prick test diagnostic skin test.\n7. Subjects treated with beta-blockers.\n8. Clinically unstable subjects at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc.).\n9. Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema.\n10. Subjects who have any pathology in which adrenaline administration is contraindicated (hyperthyroidism, HTN, heart disease, etc.).\n11. Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multioperated patients, kidney disease,).\n12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.\n13. Subject whose condition prevents from offering cooperation and\u002F or who has severe psychiatric disorders.\n14. Subjects with a known allergy to components of the investigational medicinal product other than the allergen.\n15. Subjects with lower respiratory diseases other than asthma such as emphysema or bronchiectasis.\n16. Subjects who are direct relatives of the researchers.\n17. Pregnant or lactating women.",{"count":96,"type":22},180,[25],"A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Immunotherapy in Patients With Rhinitis\u002FRhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to cupressaceae and grasses.",[100,29,101],"Rhinitis, Allergic","Asthma, Allergic",[103,104,74,105,106,107],"Rhinitis\u002F Rhinoconjunctivitis","Mild to moderate asthma","Immunotherapy","Grass","cupressaceae","2025-05-07",{"date":110,"type":47},"2025-05-13",{"date":112,"type":47},"2021-05-31",{"date":114,"type":22},"2026-10",{"name":53,"class":54},27,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100395968","phase-3-efficacy-and-safety-evaluation-for-the-treatment-of-allergy-against-mites-100395968","NCT04435990","Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites","Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Clinical Trial With SCIT in Patients With Rhinitis\u002FRhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to Dpt. and\u002For D. Farinae","MM09-SIT-023","Inclusion Criteria:\n\n* Written informed consent.\n* Age between 12 and 65, both genders.\n* Subjects with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and\u002For rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent mild-moderate controlled asthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoides pteronyssinus and\u002For Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.\n* Subjects with a positive skin prick-test wheal size \\>5 mm higher diameter due to Dermatophagoides pteronyssinus and\u002For Dermatophagoides farinae. The positive and negative control of the test should give consistent results. The results will be valid 12 months prior to the signing of the informed consent.\n* Specific immunoglobulin E against house dust mites \\>3,5 KU\u002FmL (InmunoCAP® o Immulite), for the complete extract of Dermatophagoides pteronyssinus and \u002F or for Dermatophagoides farinae or for some of the molecular components of these allergenic sources\n* Subjects should preferably be monosensitized to the study allergens. In case of subjects sensitized to other aeroallergens, only those with the following characteristics may be included in the study:\n\n  * Subjects with positive skin test to Blomia tropicalis and Lepidoglyphus destructor, whose specific IgE values do not exceed or equal the values for the study allergens. The maximum specific IgE value for these allergens is 3.5 KU\u002FL.\n  * Subjects with positive skin tests to epithelia, as long as they present occasional exposure and symptomatology.\n  * Subjects with positive skin tests to pollens, whose specific IgE values do not exceed or equal the values of the allergens in the study and who do not present exacerbations during the pollen season. The maximum value of specific IgE for these allergens is 17.5 KU\u002FL.\n* Subjects with negative skin test for fungi\n* Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial, before the first administration of the IMP.\n* Women of childbearing age participating in the trial must agree to use an appropriate method of contraception, meaning any act, device, or medication to prevent conception or viable pregnancy, during the trial if they are sexually active.\n* Subjects with a diagnosis of asthma according to the GEMA 5.0 guideline.\n* Subjects capable of complying with the dosing regimen.\n* Subjects who own an smartphone for symptom registration and medication\n\nExclusion Criteria:\n\n* Subjects who have received previous immunotherapy in the previous 5 years to dander, fungi, and mites.\n* Subjects 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.\n* Subjects with persistent severe or uncontrolled asthma, with an FEV1\\\u003C70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent or persistent rhinitis\u002Frhinoconjunctivitis with severe symptoms in whom oral or systemic antihistamine therapy is contraindicated.\n* Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.\n* Subjects under treatment with β-blockers.\n* Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).\n* Subjects with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema.\n* Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathy).\n* Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.\n* Subject whose condition prevents him\u002Fher from offering cooperation and\u002For who has serious mental illness.\n* Subjects with a known allergy to other components of the investigational medicinal product other than the allergen.\n* Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.\n* Direct investigator's relatives.\n* Pregnant women or breastfeeding women.",{"count":126,"type":22},150,[25],"A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis\u002Frhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and \u002For Dermatophagoides farinae.",[100,29,101],[103,104,74,105,131],"Mites",{"date":110,"type":47},{"date":134,"type":47},"2020-10-06",{"date":136,"type":22},"2026-12",{"name":53,"class":54},32,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":158,"locationsCount":138},"100430911","phase-3-efficacy-and-safety-evaluation-for-the-treatment-of-allergy-against-grass-and-olive-pollen-100430911","NCT04891237","Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen","A Randomized, Double-Blinded, Placebo-Controlled, Prospective, Multicenter CT to Evaluate Efficacy and Safety of Subcutaneous Immunotherapy in Subjects With Rhinitis With\u002FWithout Mild to Moderate Asthma Sensitized to Olive and Grass Pollen","Inclusion Criteria:\n\n1. Subject who has signed the informed consent.\n2. Subjects of both sexes aged between 12 and 65 years.\n3. Subjects with confirmed clinical history of inhalational allergy (rhinitis and \u002F or moderate-severe intermittent or persistent rhinoconjunctivitis according to the ARIA classification with or without intermittent or persistent controlled mild-moderate asthma according to the GEMA 5.0 classification caused by grass and olive allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent\n4. Subjects with a positive prick test (higher papule diameter ≥ 5 mm) to a standardized extract of pollen from grasses (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or one of the components of the mixture and an olive extract.\n5. Specific IgE (CAP or Immulite) against a mixture of grasses or against one of the components of the mixture of grasses, preferably Phleum pratense and olive or one of the molecular components of allergenic sources with a value \\> 3,5 KU \u002F L.\n6. Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of joining the trial.\n7. Women of childbearing potential, and men participating in the trial, should commit to using an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices placed at least 3 months in advance, surgical sterilization (for example, tubal ligation), barrier methods, or the use of oral contraceptives.\n8. Subjects capable of complying with the dosage regimen.\n9. Subjects who have a smartphone to record symptoms and medication.\n10. Subjects with a negative prick test to coestational pollens. In the case specific IgE is available, the result should be \\\u003C3,5 kU\u002FL and without relevant symptomatology\n11. Subjects with a negative prick test to other aeroallergens (dust mites, epitheliums and fungus). In the case specific IgE is available, the result should be \\\u003C3,5 kU\u002FL and without relevant symptomatology\n\nExclusion Criteria:\n\n1. Subjects polysensitized to other aeroallergens with the exception of epithelia with occasional exposure and symptoms\n2. Subjects polysensitized to other aeroallergens with the exception non-seasonal pollens with grasses and olive\n3. Subjects who have received prior immunotherapy in the preceding 5 years to any aeroallergens.\n4. Subjects in which 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.\n5. Subjects with severe or uncontrolled persistent asthma, with an FEV1 \\\u003C70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis \u002F rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated.\n6. Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.\n7. Subjects under treatment with ß-blockers.\n8. Clinically unstable subjects at the time of enrolment in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).\n9. Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburns, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema.\n10. Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).\n11. Subjects with some other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multiple operations, kidney disease,).\n12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.\n13. Subject whose condition prevents him \u002F her from offering cooperation and who has severe psychiatric disorders.\n14. Subjects with a known allergy to other investigational drug components other than the allergen.\n15. Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.\n16. Subjects who are direct relatives of the researchers.\n17. Pregnant or lactating women.",{"count":96,"type":22},[25],"Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with mild to moderate rhinitis \u002F rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and olive",[100,29,101],[103,104,74,151,152],"Grasses","Olea","2025-05-05",{"date":108,"type":47},{"date":156,"type":47},"2021-06-14",{"date":85,"type":22},{"name":53,"class":54},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":167,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":171,"conditions":172,"keywords":176,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100576828","immunotherapy-for-the-treatment-of-hymenoptera-venom-allergy-in-real-life-conditions-100576828","NCT06790368","Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.","Prospective Clinical Follow-up to Evaluate the Safety of Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.","Venox-23","Inclusion Criteria:\n\n* The study population consisted of allergic participants indicated for treatment with hymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according to standard clinical practice.\n* Participants of both sexes aged 14 years or more.\n* Participants who have not received immunotherapy with hymenoptera venom in the previous 5 years.\n* Participants who have agreed to take part in the study and sign the informed consent form. In the case of minors, the patient's parent or guardian must also sign.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.\n* Participants who do not agree to participate and\u002For do not sign the informed consent form.\n* Participants who do not comply with medical indications or do not cooperate with immunotherapy treatment.","14 Years",{"count":169,"type":22},80,"OBSERVATIONAL","Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), multicentric and data will be collected prospectively.",[173,174,175],"Allergy, Insect Venom","Allergy Insect Stinging","Insect Sting Allergy",[74,105,177,178,179],"Apis mellifera","Vespula sp","controlled sting","2025-04-30",{"date":182,"type":47},"2025-05-01",{"date":184,"type":47},"2025-01-01",{"date":186,"type":22},"2026-06-01",{"name":53,"class":54},3,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":167,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":5},"100576201","prospective-observational-study-to-evaluate-the-safety-of-immunotherapy-as-a-treatment-for-hymenoptera-venom-allergy-100576201","NCT06782217","Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy","Inclusion Criteria:\n\n1. The study population consisted of allergic participants indicated for treatment with immunotherapy with hymenoptera venom (Apis mellifera or Vespula spp.) according to standard clinical practice.\n2. Age equal to or older than 14 years, without gender differences.\n3. Not having received immunotherapy with hymenoptera venom in the previous 5 years.\n4. That they agree to participate in the study and sign the informed consent form. In the case of minors, the parent or guardian of the participant must also sign the informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.\n3. Participants who do not agree to participate and\u002For do not sign the informed consent form.\n4. Participants who do not comply with the medical indications or do not show cooperation with respect to the immunotherapy treatment.\n5. Participants with oncological diseases under active treatment or with autoimmune diseases under immunosuppressive treatment.\n6. Participants in whom the administration of immunotherapy is contraindicated.",{"count":196,"type":22},120,"Observational study to evaluate the safety of immunotherapy as a treatment for Hymenoptera venom allergy, analyzing the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting. This study will be conducted in Spain (multicentric) and data will be collected prospectively.",[173,174,175],[74,200,177,201,202],"Immunothepary","Vespula spp.","Insect venom",{"date":204,"type":47},"2025-05-04",{"date":206,"type":47},"2024-09-01",{"date":208,"type":22},"2027-02-01",{"name":53,"class":54},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":217,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":87},"100480175","quercus-ilex-and-quercus-robur-allergen-extracts-standardisation-100480175","NCT05532566","Quercus Ilex and Quercus Robur Allergen Extracts Standardisation","Quercus Ilex and Quercus Robur Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).","Inclusion Criteria:\n\n* Subjects must live in a geographical area where allergic problems caused by Quercus ilex and Quercus robur are relevant.\n* Positive clinical history of inhalant allergy (rhinitis and\u002For rhinoconjunctivitis and\u002For asthma) to asthma) to Quercus ilex and Quercus robur.\n* A positive prick-test (mean papule diameter ≥ 3 mm) with an extract of the same allergen and\u002For presence of specific IgE against that allergen.\n* The mean papule area obtained with Histamine dichlorhydrate at 10 mg\u002FmL should be ≥ 7 mm2.\n* Age: Between 18 and 64 years old.\n* Subjects must be able to give informed consent.\n\nExclusion Criteria:\n\n* Subjects should not be excluded in terms of low or high sensitivity to Quercus ilex and Quercus robur.\n* Subjects outside the age range.\n* Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or rhinoconjunctivitis for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Quercus ilex and Quercus robur extracts.\n* Subjects with significant symptoms of rhinoconjunctivitis and\u002For bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated.\n* Subjects who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test.\n* Subjects under treatment with ß-blockers.\n* Subjects clinically unstable (acute asthma, febrile, etc.).\n* Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).\n* Subjects with active viral infection by herpes simplex or herpes varicella zoster in the area where the prick test is performed.\n* Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.).\n* States of the subject in which he\u002Fshe cannot offer cooperation and severe psychiatric disorders.\n* Pregnant women or women at risk of pregnancy and lactating women.",{"count":66,"type":22},[68],"The objective of this study is to determine the biological activity of Quercus illex and Quercus robur allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).",[221,72,222],"Allergic Reaction","Allergy Pollen",[74],{"date":182,"type":47},{"date":226,"type":47},"2023-01-24",{"date":228,"type":22},"2025-11-30",{"name":53,"class":54},{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":241,"briefSummary":243,"conditions":244,"keywords":249,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":87},"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.","60 Years",{"count":240,"type":22},90,[242,25],"PHASE2","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).",[245,246,247,248],"Allergic Rhinitis","Allergic Asthma","Allergic Rhinoconjunctivitis","Allergy to House Dust Mite",[74,131,250,28,29],"Hypersensitivity","2023-10-20",{"date":253,"type":47},"2023-10-23",{"date":255,"type":22},"2023-11-01",{"date":257,"type":22},"2026-12-01",{"name":53,"class":54},""]