Retrospective Study Evaluating the Effectiveness and Safety of Immunotherapy With Clustoid®/Clustek®/Alxoid® for the Treatment of Dermatophagoides/Blomia Tropicalis Allergy in Real-Life Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Combined Symptom and Medication Scores for asthma (ACSMS) in the Treatment of Dermatophagoides/Blomia tropicalis Allergy
研究概览
简要总结
House dust mites are the main source of allergies in indoor environments. They are predominant in coastal areas, with the Canary Islands being the autonomous community with the highest percentage of patients with rhinoconjunctivitis due to sensitisation to these mites (94.7%).
Immunotherapy is indicated for the treatment of allergic rhinoconjunctivitis and is capable of altering the natural course of allergic diseases.
The aim of the study was to evaluate the efficacy and safety of Clustoid® Max Forte in the treatment of patients with respiratory allergy to Dermatophagoides/Blomia tropicalis.
详细描述
Retrospective observational study of the effectiveness and safety of Clustoid® Max Forte for Dermatophagoides (D. pteronyssinus, D. farinae)/ Blomia tropicalis at concentrations of 30,000/30,000 Titer Units per milliliter (TU/mL) or 30,000/10,000 TU/mL in patients with allergic rhinitis/rhinoconjunctivitis with/without asthma, treated for a minimum of 1 year.
To assess effectiveness, the combined symptom and medication scores (PSPM) for rhinitis/rhinoconjunctivitis and asthma prior to treatment (T=0) and annually up to 5 years post-initiation (T=5) were studied and compared. To assess safety, adverse reactions were collected and evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study population consists of patients with respiratory allergic disease who are indicated for treatment with Clustoid® Max Forte immunotherapy according to standard clinical practice.
- •Age between 5 and 65 years, with no gender differences.
- •Who have received immunotherapy for at least one year.
排除标准
- •1.Patients who have received immunotherapy with airborne allergens prior to the treatment to be evaluated in this study.
研究组 & 干预措施
Patients with respiratory allergic diseases treated with Clustoid Max Forte
Patients with respiratory allergic diseases (allergic rhinitis/rhinoconjunctivitis with or without asthma) who have been treated or are being treated with Clustoid® Max Forte Dermatophagoides/Blomia tropicalis, for both concentrations 30,000/30,000 TU/mL and 30,000/10,000 TU/mL. (ATC code: V01AA07)
干预措施: Clustoid® Max Forte (Biological)
结局指标
主要结局
Combined Symptom and Medication Scores for asthma (ACSMS) in the Treatment of Dermatophagoides/Blomia tropicalis Allergy
时间窗: 12-60 months
Combined Symptom and Medication Scores for asthma (ACSMS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year.
Rhinoconjunctivitis Symptom Score (RSS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy
时间窗: 12-60 months
Rhinoconjunctivitis Symptom Score (RSS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year. Evaluation of six symptoms: nasal pruritus, sneezing, rhinorrhoea, nasal obstruction (for rhinitis), ocular pruritus/redness, watery eyes (for conjunctivitis). Symptom Scores for rhinoconjunctivitis (RSS) will be the sum of scores for all six symptoms divided by 6. Each symptom scored from 0 to 3. The assessment criteria for each symptom shall be as follows: 0 = no symptoms 1. = mild (present, minimal awareness, easily tolerated) 2. = moderate (clear awareness but tolerable) 3. = severe (hard to tolerate, interferes with daily activity or sleep)
Asthma Symptom Score (ASS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy
时间窗: 12-60 months
Asthma Symptom Score (ASS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year. Evaluation of four symptoms: cough, dyspnoea, chest tightness, wheezing. Asthma Symptom Score (ASS) will be the sum for all four symptoms divided by 4. Each symptom scored from 0 to 3. The assessment criteria for each symptom shall be as follows: 0 = no symptoms 1. = mild (present, minimal awareness, easily tolerated) 2. = moderate (clear awareness but tolerable) 3. = severe (hard to tolerate, interferes with daily activity or sleep)
Asthma Medication Score (AMS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy
时间窗: 12-60 months
Asthma Medication Score (AMS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year. 0 = no medication 0.5 = short-acting β2-agonists (SABA) on demand 1. = low-dose inhaled corticosteroids (ICS) / antileukotrienes (LTRA) 1.5 = low-dose ICS + Long-Acting Beta-Agonist (LABA) / medium-dose ICS ± LTRA ± SABA 2. = medium-dose ICS + LABA ± LTRA ± SABA 2.5 = high-dose ICS + LABA ± LTRA ± SABA 3. = high-dose ICS + LABA + systemic corticosteroids (CS) ± LTRA ± SABA
Rhinoconjunctivitis Medication Score (RMS) for the Treatment of Dermatophagoides/Blomia tropicalis Allergy
时间窗: 12-60 months
Rhinoconjunctivitis Medication Score (RMS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year. 0 = no medication 1. = oral/topical antihistamines (eyes and/or nose) 2. = intranasal corticosteroids with/without antihistamines 3. = oral corticosteroids with/without antihistamines
Combined Symptom and Medication Scores for Rhinoconjunctivitis (RCSMS) in the Treatment of Dermatophagoides/Blomia tropicalis Allergy
时间窗: 12-60 months
Combined Symptom and Medication Scores for rhinoconjunctivitis (RCSMS) shall be counted before starting immunotherapy and annually during treatment, ensuring comparability by evaluating the same season each year.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Associated With Clustoid® Max Forte
时间窗: 12-60 months
Number, type, nature, intensity, and severity of treatment-emergent adverse reactions, including local and systemic events, in subjects receiving immunotherapy for Dermatophagoides/Blomia tropicalis allergy.
次要结局
未报告次要终点