EUCTR2006-005868-10-HU进行中（未招募）不适用
Multicenter, Randomized, Double-Blind Placebo-Controlled Study, Subcutaneous Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum pratense Pollen in Hypersensitivity Patients to grass Pollen.
aboratorios LETI S.L.0 个研究点目标入组 148 人开始时间: 2010年5月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Informed consent, signed by the patient.
- •Clinical history of moderate to severe rhinitis/rhinoconjunctivitis lasting for at least 2 consecutive years, with or without episodic asthma, caused by allergy to grass pollen. Moderate to severe rhinoconjunctivitis is defined as having one or more of the following symptoms: sleep disorders; difficulties in performing routine leisure and/or sports activities; difficulties in carrying out everyday work or school activities; symptoms that cause discomfort to the patient.
- •Patients who have both rhinitis/rhinoconjunctivitis and episodic asthmatic symptoms will be identified by a normal spirometry and the absence of symptoms outside the pollination season. The following criteria during the pollination period must be fulfilled, either through the patient’s clinical history or during the spring of the current year:
- •a) Worsening of the pulmonary function ?15% in FEV1 or 25% of FEF25-75% compared to controls performed during a previous period with no antigen load.
- •b) Obstructive spirometry with an improvement of >12% in FEV1 after use of short-acting bronchodilator, beta-agonist.
- •c) In the case of obstructive spirometry with no improvement following short-acting B2 agonist, anti-inflammatory medication will be added to control the symptoms. At the end of the pollination season, patient will have to show an increase in the FEV1 value of at least 12% with respect to the baseline value.
- •d) In the case of a normal spirometry and a history suggestive of exercise-induce asthma, confirmation of a change of ?10% with respect to the baseline values is necessary after the stress test*.
- •Aged between 18 and 55 years.
- •Symptoms that coincide with allergy to grass pollen, defined as the presence of seasonal symptoms (during the most intensive grass pollination period) such as sneezing, a runny, blocked or itchy nose, reddening of the eyes, irritation or itching of the eyes, tearing, which may or may not be accompanied by coughing, wheezing and dyspnoea.
- •Sensitivity to grass pollen, diagnosed through a positive skin reaction to Phleum pratense: the papule produced by the prick-test must be equal to or larger than the papule produced by the positive control (histamine 10 mg/ml); and/or due to the presence of specific IgE versus P. pratense >0.7 kU/L. The patients included must be mono-sensitised or, in the case of poly-sensitisation, sensitivity to P. pratense pollen should be considered as the only relevant aspect of their condition from the clinical standpoint during the time they are included in the study. The result of immunoserology tests performed within less than one year will be accepted.
- •Patients who are able to:
- •Comply with the dose regime
- •Give their informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 148
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients suffering from only mild rhinitis/rhinoconjunctivitis
- •Patients outside the specified age group.
- •Relevant sensitivity to any other perennial allergen (fungi, animal epithelia, etc. if not removed from the patient’s vicinity).
- •Patients who have previously received immunotherapy for asthma or allergic rhinitis/rhinoconjunctivitis during the past 4 years. Neither may patients for whom immunotherapy is absolutely contraindicated in general in accordance with the criteria of the Immunotherapy Committee of the Spanish Allergy and Clinical Immunology Society (1) and the European Allergy and Clinical Immunology Immunotherapy Subcommittee (2) be included: Patients being treated with ß-blocker drugs.
- •Patients suffering from pathologies in which adrenalin is contraindicated (hyperthyroidism, HBP, heart disease, etc.).
- •Patients with other diseases not related to asthma but which are potentially serious and could interfere with treatment and follow-up (epilepsy, psychomotor alterations, diabetes, malformations, patients undergoing repeated surgery, kidney disease,..).
- •Autoimmune diseases (thyroiditis, lupus, etc.).
- •Patients who are unable to cooperate, and who suffer from severe psychiatric alterations.
- •The co-existence of intolerance to aspirin.
- •Patients who are pregnant or planning to become pregnant and patients who are breastfeeding.
研究者
相似试验
进行中（未招募）
不适用
Multicenter, Randomized, Double-Blind, Placebo Controlled Phase IIb/III Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients with Degenerative ArthritisDiseases of the musculo-skeletal system and connective tissueKCT0001619R-bio24
进行中（未招募）
1 期
Multicenter randomized, double-blind, placebo-controlled parallel clinical trial to assess efficacy and safety of Omalizumab (Xolair®) in a new indication: cholinergic urticaria.Cholinergic urticariaEUCTR2013-002770-43-ESClínica Universidad de Navarra/Universidad de Navarra24
进行中（未招募）
1 期
Acetylsalicylic acid in the prevention of severe COVID-19 pneumonia in hospitalised patientsCovid-19MedDRA version: 20.0Level: LLTClassification code 10076502Term: Viral pneumonitisSystem Organ Class: 100000004862EUCTR2020-006130-12-ITAZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA204
已完成
3 期
Multicenter double-blind, randomized, placebo-controlled trial of IDEC-C2B8 for the treatment of childhood-onset nephrotic syndrome(JSKDC10)Childhood onset idiopathic nephrotic syndrome showing frequent relapse or steroid dependenceJPRN-jRCT1091220380Kobe University Hospital40
进行中（未招募）
1 期
A study of ixekizumab (LY2439821) in participants from 6 to less than 18 years of age with moderate to severe plaque psoriasis.Moderate-to-Severe Plaque PsoriasisMedDRA version: 19.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2016-003331-38-ESilly S.A.201