CTIS2024-514524-16-00进行中（未招募）1 期
Prospective, multicentre, randomized, double-blind, placebo-controlled, clinical trial of efficacy and safety with subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma sensitized to grasses and cupressaceae - DMV02-SIT-026
Inmunotek S.L.0 个研究点目标入组 180 人开始时间: 2024年8月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
- 性别
- All
入选标准
- •1.Subject who has signed the informed consent form., 10.Subjects with negative skin test for co-seasonal pollens. In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs., 11.Subjects with negative skin test for other aeroallergens (mites, dander, and fungi). In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs., 2.Subjects of both sexes aged between 12 and 65 years., 3.Subjects with a confirmed clinical history of inhalation allergy (moderate-severe intermittent or persistent rhinitis and/or rhinoconjunctivitis according to the ARIA classification, with or without mild-moderate controlled intermittent or persistent asthma according to the GEMA 5.0 classification) caused by grass and cupressaceae allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent., 4.Subjects with a positive skin prick test (wheal major diameter = 5 mm) to a standardised extract mixture of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or to one of the components of the mixture and a cupressaceae extract., 5.Specific IgE (CAP or Immulite) to a grass mixture or to one of the components of the grass mixture, preferably to Phleum pratense and cupressaceae or to one of the molecular components of the allergenic sources with a value > 3.5 KU/L., 6.Women of childbearing age (from menarche) must present a urine pregnancy test with negative result at the time of entry into the trial., 7.Women of childbearing age participating in the trial must agree to use an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices inserted at least 3 months in advance, surgical sterilisation (e.g., tubal ligations), barrier methods, or the use of oral contraceptives., 8.Subjects able to comply with the dosing regimen., 9.Subjects with a smartphone to record symptoms and medication consumption.
排除标准
- •1.Subjects with positive skin prick test to other aeroallergens, except for dander with occasional exposure and symptomatology., 10.Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.)., 11.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, nephropathies)., 12.Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies., 13.Subject whose condition prevents him/her from offering cooperation and/or who has severe psychiatric disorders., 14.Subjects with known allergy to components of the investigational medicinal product other than the allergen., 15.Subjects with lower respiratory tract diseases other than asthma such as emphysema or bronchiectasis., 16.Subjects who are immediate family members of investigators., 17.Pregnant or breastfeeding women., 2.Subjects with positive skin prick test for other aeroallergens, except for non-co-seasonal pollens with grasses and cupressaceae., 3.Subjects who have received immunotherapy to pollens in the last 5 years or are currently receiving immunotherapy with any allergen., 4.Subjects in whom immunotherapy may be subject to 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., 5.Subjects with severe or uncontrolled persistent asthma, with an FEV1<70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom discontinuation of oral or systemic antihistamine treatment is contraindicated., 6.Subjects who have previously exhibited a severe secondary reaction during diagnostic skin prick test., 7.Subjects on treatment with ß-blockers., 8.Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, febrile process, acute urticaria, etc.)., 9.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.
研究者
相似试验
进行中（未招募）
1 期
Clinical trial to assess the efficacy and safety of a vaccine for grasses and olive tree allergyAetiological treatment of moderate-severe intermitent or persistent allergic rhinitis/rhinoconjunctivitis with or without controlled mild-moderate intermittent or persistent allergic asthmaMedDRA version: 20.0Level: LLTClassification code: 10036019Term: Pollen allergy Class: 10021428MedDRA version: 26.0Level: LLTClassification code: 10034382Term: Perennial allergic rhinitis Class: 10038738MedDRA version: 27.0Level: LLTClassification code: 10070526Term: Grass allergy Class: 10021428MedDRA version: 20.0Level: LLTClassification code: 10001728Term: Allergic rhinoconjunctivitis Class: 10015919MedDRA version: 21.1Level: LLTClassification code: 10001705Term: Allergic asthma Class: 10038738CTIS2024-514525-34-00Inmunotek S.L.180
进行中（未招募）
1 期
Clinical trial to evaluate the efficacy of a 0.005% estriol vaginal gel in the prevention of recurrent urinary tract infections in postmenopausal women with vaginal atrophy.Recurrent Urinary Tract Infection (UTI) in postmenopausal women with vaginal atrophy.MedDRA version: 20.0Level: LLTClassification code 10038140Term: Recurrent urinary tract infectionSystem Organ Class: 100000004862EUCTR2018-001481-42-ESITF RESEARCH PHARMA S.L.U.120
进行中（未招募）
1 期
Dose-response study of efficacy and safety of Botulinum toxin type A to treat spasticity of the leg(s) in cerebral palsyower limb spasticity due to cerebral palsyMedDRA version: 17.1Level: LLTClassification code 10058977Term: Spastic paresisSystem Organ Class: 100000004852EUCTR2012-005054-30-SKMerz Pharmaceuticals GmbH300
进行中（未招募）
1 期
Prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, efficacy and safety phase 3 study of an intravenous human plasma-derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacksacute hereditary angioedema attacksMedDRA version: 20.0Level: LLTClassification code: 10075280Term: Hereditary angioedema attack Class: 10010331MedDRA version: 21.0Level: LLTClassification code: 10080960Term: Hereditary angioedema type II Class: 10010331MedDRA version: 21.0Level: LLTClassification code: 10080957Term: Hereditary angioedema C1 inhibitor deficiency Class: 10010331MedDRA version: 21.0Level: LLTClassification code: 10080956Term: Hereditary angioedema type I Class: 10010331CTIS2023-503507-29-00Octapharma Pharmazeutika Produktionsgesellschaft mbH124
尚未招募
4 期
Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritisrheumatoid arthritisITMCTR2100005057Guang'anmen Hospital, China Academy of Chinese Medical Sciences