NCT04874714终止3 期
Prospective, Randomized, Placebo-controlled, Multi-center Trial Comparing the Efficacy and Safety of Subcutaneous Immunotherapy With a Mixture of Grasses and Mites at Adequate Doses Versus Monotherapy, for the Treatment of Allergy
Inmunotek S.L.26 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年4月30日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 26
- 主要终点
- CSMS: Combined Symptoms and Medication Score
研究概览
简要总结
Prospective, randomized, placebo-controlled, multicenter of 3 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and allergic rhinitis/rhinoconjunctivitis (intermittent or persistent) due to hypersensitivity to house dust mites (Dermatophagoides pteronyssinus and / or D. farinae) and grass pollen
详细描述
Double blind, parallel placebo-controlled study. The subjects will receive medication during 11 months
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
- Triple (Participant, 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
- •Subjects who have signed the informed consent
- •Subjects with a confirmed medical history of asthma (intermittent or persistent mild-moderate, controlled), as defined by GEMA 5 with moderate-severe rhinitis / rhinoconjunctivitis (intermittent or persistent) according to the ARIA classification caused by polysensitization to grass pollen and mites (D. pteronyssinus and / or D. farinae). The diagnosis of asthma will be valid from 24 months prior to signing the informed consent.
- •Subjects with a positive prick test (major diameter of the papule ≥ to 5 mm) to a standardized extract of grass pollen mixture, or to one of the components of the mixture (Dactilys glomerata, Poa pratensis, Holcus lanatus, Festuca elatior, Phleum pratense and Lolium perenne) and to an extract of D. pteronyssinus and / or D. farinae. Results will be valid 12 months prior to signing the informed consent.
- •Specific IgE (CAP or Immulite) against one of the components of the mixture of grasses, preferably Phleum pratense or a mixture of grasses and mites (D. pteronyssinus and / or D. farinae) or one or more of the molecular components of allergenic sources with a value > 3,5 KU / L. Results will be valid 12 months prior to signing the informed consent.
- •Subjects will preferably be sensitive to study allergens (Dermatophagoides and grasses). In the case of subjects sensitized to other aeroallergens, only those with the following characteristics (results valid up to 12 months prior to signing of the informed consent) can be included in the study:
- •Subjects with a positive prick test for Blomia tropicalis and Lepidoglyphus destructor, whose maximum values of specific IgE are 3.5 KU/L and do not exceed or equal the values of the allergens of the study (Dermatophagoides and grasses).
- •Subjects with a negative prick test to epithelium, whose specific IgE values are < 0.35 KU/L. Subjects with occasional exposure and symptomatology to epithelium may be included with a positive prick test regardless of the value of the specific IgE.
- •Subjects with a positive prick test for non-coestational pollens, whose maximum values of specific IgE are 17.5 KU / L and do not exceed or equal the values of the allergens of the study (Dermathophagoids and grasses) and who also do not present exacerbations in the pollen season.
- •Subjects with a negative prick test for fungi. If the specific IgE determination has been made, the result shall be < 0,35 KU/L.
- •Subjects with a negative prick test for coestacional pollens with grasses. If the specific IgE determination has been made, the result shall be < 0,35 KU/L.
- •Subjects aged between 12 and 65 years, inclusive.
- •Subjects capable of complying with the dosing regimen.
- •Women of childbearing age (from menarche) should submit a urine pregnancy test with a negative result at the time of enrolment in the trial.
- •Women of childbearing potential should commit to using an adequate 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.
- •Subjects who have a smartphone to record symptoms and medication.
排除标准
- •Subjects who have received prior immunotherapy treatment in the preceding 5 years for any aeroallergen.
- •Patients in whom immunotherapy may be the object of 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 cannot be included.
- •Subjects with severe or uncontrolled asthma, and / or with a FEV1 <70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial.
- •Subjects who have previously presented a serious secondary reaction during the performance of diagnostic skin tests using the prick test.
- •Subjects under treatment with ß-blockers.
- •Subjects under treatment with immunosuppressive or biological drugs.
- •Clinically unstable subjects at the time of inclusion in the trial (respiratory infection, feverish process, acute urticaria, etc.).
- •Subjects with chronic urticaria in the past 2 years, severe anaphylaxis, or a history of hereditary angioedema.
- •Subjects who have any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HT, heart disease, etc.).
- •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, diabetes, malformations, subjects who underwent multiple surgeries, kidney disease...), according to investigator's criteria.
- •Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or with a diagnosis of immunodeficiencies.
- •Subject whose condition prevents him / her from offering cooperation and or who resents severe psychiatric disorders, according to investigator criteria.
- •Subjects with known allergies to other investigational product components other than grass pollen or mites.
- •Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis.
- •Pregnant or lactating women.
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 necessary for the control of such symptoms in asthma and rhinitis / rhinoconjunctivitis of each subject during the trial, of the groups with each other and with respect to placebo. - The endpoint for each asthma and rhinitis / rhinoconjunctivitis symptom will be as follows: 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe Total daily symptom score = 0-3 * The asthma medication will be scored based on the therapeutic step in which drugs are included in the GEMA 5 guide. * The rhinitis / rhinoconjunctivitis medication score: 0 = No medication; 1 = oral or topical (eyes or nose) non-sedative H1 antihistamines (H1A); 2 = intranasal corticosteroids (INS) with / without H1A; 3 = oral corticosteroids with/without (INS), with/without H1A Total daily medication score = 0-3
次要结局
- Respiratory function_PEF(12 months)
- Medication-free days(12 months)
- Asthmatic exacerbations(12 months)
- Visual Analogue Scale (VAS)(12 months)
- Quality of life associated with rhinitis(12 months)
- Security parameters(12 months)
- Number of Local Adverse Reactions(12 months)
- Symptom-free days(12 months)
- Respiratory function_FEV1(12 months)
- Immunological parameters(12 months)
- Quality of life associated with asthma(12 months)
- Consumption of health resources(12 months)
- Number of Systemic Adverse Reactions(12 months)
- Number of Adverse Reactions to any medication(12 months)
研究者
研究点 (26)
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