NCT04435990招募中3 期
Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Clinical Trial With SCIT in Patients With Rhinitis/Rhinoconjunctivitis With or Without Mild to Moderate Asthma Sensitized to Dpt. and/or D. Farinae
Inmunotek S.L.31 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年10月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 31
- 主要终点
- CSMS: Combined Symptoms and Medication Score
研究概览
简要总结
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/rhinoconjunctivitis with or without asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.
详细描述
Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 12 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
During the trial, both the investigator and the included subjects will be unaware of the treatment each subject is receiving.
The person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed.
So that neither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Age between 12 and 65, both genders.
- •Subjects with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or 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/or Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.
- •Subjects with a positive skin prick-test wheal size >5 mm higher diameter due to Dermatophagoides pteronyssinus and/or 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.
- •Specific immunoglobulin E against house dust mites >3,5 KU/mL (InmunoCAP® o Immulite), for the complete extract of Dermatophagoides pteronyssinus and / or for Dermatophagoides farinae or for some of the molecular components of these allergenic sources
- •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:
- •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/L.
- •Subjects with positive skin tests to epithelia, as long as they present occasional exposure and symptomatology.
- •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/L.
- •Subjects with negative skin test for fungi
- •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.
- •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.
- •Subjects with a diagnosis of asthma according to the GEMA 5.0 guideline.
- •Subjects capable of complying with the dosing regimen.
- •Subjects who own an smartphone for symptom registration and medication
排除标准
- •Subjects who have received previous immunotherapy in the previous 5 years to dander, fungi, and mites.
- •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.
- •Subjects with persistent severe or uncontrolled 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 oral or systemic antihistamine therapy is contraindicated.
- •Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
- •Subjects under treatment with β-blockers.
- •Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.).
- •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.
- •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).
- •Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies.
- •Subject whose condition prevents him/her from offering cooperation and/or who has serious mental illness.
- •Subjects with a known allergy to other components of the investigational medicinal product other than the allergen.
- •Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
- •Direct investigator's relatives.
- •Pregnant women or breastfeeding women.
研究组 & 干预措施
Placebo subcutaneous
Placebo Comparator
The same solution and presentation as the active treatment, but without any active ingredients.
干预措施: Placebo subcutaneous (Biological)
Experimental:10,000 MM09
Experimental
10,000 TU/mL of subcutaneous immunotherapy
干预措施: 10,000 MM09 (Biological)
Experimental: 30,000 MM09
Experimental
30,000 TU/mL of subcutaneous immunotherapy
干预措施: 30,000 MM09 (Biological)
结局指标
主要结局
CSMS: Combined Symptoms and Medication Score
时间窗: 12 months
Evaluation of the number of symptoms and the consumption of medication for symptoms rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo.
次要结局
- Medication-free days(12 months)
- Symptom-free days(12 months)
- Number of participants with treatment-related adverse events as assessed by MM09-SIT-023(12 months)
- Quality of life associated with asthma(12 months)
- Quality of life associated with rhinitis(12 months)
- Visual Analogue Scale (VAS)(12 months)
- Immunological parameters(12 months)
研究者
研究点 (31)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial MyopathyMitochondrial MyopathyNCT02367014Stealth BioTherapeutics Inc.36
已完成
2 期
Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)Confirmed Genetic Diagnosis of Prader-Willi SyndromeNCT03149445Saniona18
招募中
3 期
Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema AttacksAcute Hereditary Angio EdemaNCT06361537Octapharma124
已完成
不适用
Effect of a New Probiotic Strain in the Reduction of Group B Streptococcus Colonization in Pregnant WomenGestational MotherStreptococcus Agalactiae InfectionNCT03669094ProbiSearch SL40
已完成
不适用
A Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of MSiHy Silicone Hydrogel Soft Contact LensRefractive ErrorsMyopiaNCT06716385Visco Vision Inc.134