Prospective, Randomised, DBPC, Double-dummy, Multicenter CT of Efficacy and Safety With IT in Patients With Controlled Mild to Moderate Allergic Asthma and Rhinitis/Rhinoconjunctivitis, Allergic to D. Pteronyssinus and/or D. Farinae.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 32
- 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 rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
详细描述
Prospective multicenter randomized double-dummy clinical trial of three active treatment groups compared to one placebo group. The principal objective of the clinical trial is the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
The primary efficacy endpoint will be the symptom score and medication consumption required for the control of asthma and rhinitis/rhinoconjunctivitis symptoms.
The study design consists of 3 active treatment groups and one placebo group. The trial population will include 400 subjects between the age of 12 and 60 years that will receive the treatment during 12 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.
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated Informed Consent Form (ICF).
- •Female or male aged 12 to 60 years, both included.
- •Confirmed clinical history of inhalation allergy (mild-moderate controlled intermittent or persistent asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae). The asthma diagnosis will be valid up to 24 months prior to signing the informed consent.
- •Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
- •Specific IgE against a complete extract of D. pteronyssinus and/or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5 kU/L.
- •Women of childbearing age must have a urine pregnancy test negative result before enrolling the study.
- •Women of childbearing age must commit to using an adequate contraception method.
- •Capable of complying with dosage regimen.
- •Owning a smartphone to register symptoms and medication consumption.
- •A negative skin prick test to other aeroallergens with specific IgE < 3.5 kU/L with no clinical relevance.
排除标准
- •Previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (ITO, milk, egg, ...) or currently receiving immunotherapy with any other allergen.
- •Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander.
- •Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.
- •Uncontrolled or severe asthma and/or FEV1 <70% despite pharmacological treatment by the time of enrolment.
- •Intake of β-blockers.
- •Use of immunosuppressive or biological drug.
- •Unstable patients by the time of enrolment (acute exacerbation asthma, respiratory infection, fever, acute pruritus, etc).
- •Patients who have suffered chronic urticaria during the last 2 years, severe anaphylaxis, or family history of angioedema.
- •Having any contraindication for the use of adrenaline (hyperthyroidism, heart disease, high blood pressure).
- •Other severe diseases not related to allergic asthma or rhinitis that could interfere in the study treatment or the follow-up (epilepsy, psychomotor agitation, diabetes, malformations, nephropathy) according to medical criteria.
- •Autoimmune diseases (thyroiditis, lupus, etc.), tumoral diseases or immunodeficiencies.
- •Participants that the investigator believes could not comply with the study protocol or have serious psychiatric disorders.
- •Known allergy to any of the ingredients of the study medication except for mites.
- •Lower respiratory tract diseases different from asthma as bronchiectasis or chronic obstructive pulmonary disease.
- •Breast-feeding or pregnant women.
- •Being immediate family of the investigator.
- •Concurrent participation in other clinical trials or prior participation within 30 days prior to inclusion.
- •History of serious systemic reactions, including food, Hymenoptera venom, medications, etc.
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
- Asthma symptom-free days(12 months)
- Rhinitis / rhinoconjunctivitis symptom-free days(12 months)
- Asthmatic exacerbations(12 months)
- Asthma medication-free days(12 months)
- Rhinitis / rhinoconjunctivitis medication-free days(12 months)
- Respiratory function_PEF(Baseline, month 6, month 12)
- Clinical benefit(12 months)
- Immunological parameters(12 months)
- Quality of life associated with rhinoconjunctivitis (RQLQ)(Baseline, month 6, month 12)
- Questionnaire for asthma control (ACQ)(12 months)
- Visual Analogue Scale (VAS)(12 months)
- Consumption of health resources(12 months)
- Respiratory function_FEV1(Baseline, month 6, month 12)
- Quality of life associated with asthma (AQLQ)(12 months)
- Safety parameters(12 months)
- Number of Local Adverse Reactions(12 months)
- Number of Systemic Adverse Reactions(12 months)