Evaluation in Routine Practice of the Benefits of Sublingual Allergen Immunotherapy in Allergic Patients According to Different Modalities of Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,635
- 试验地点
- 1
- 主要终点
- PBQ (Patient Benefit Questionnaire)
研究概览
简要总结
The objective of the study was to evaluate in routine practice the benefits of sublingual allergen immunotherapy (SLIT) for allergic patients with allergic rhinitis (AR), with or without asthma, according to various methods of use (treatment regimen: formulation type, dose, duration, initiation) and type of allergen (grass pollen, tree pollen, herbaceous pollen, house dust mites, animal dander, moulds and poly-reactive types).
详细描述
The treatment considered was any SLIT (tablet or liquid forms) accepted by the patient and the parent(s) in the case of minor patients. The treatment was taken as prescribed by the observing physician.
The expected benefits for patients after approximately 6 and 12 months after initiation of SLIT included:
- Decreased intensity of symptoms
- Decreased discomfort
- Decreased consumption of symptomatic treatments or associated treatments (especially in asthmatic patients)
- Improved quality of life
- Reduced absenteeism from school or work
- Beneficial impact on leisure activities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 5 years or older
- •Patients with a respiratory allergy with significant clinical symptoms and whose diagnosis was confirmed by a positive skin prick-test and/or the presence of specific IgE antibodies to one or more allergens implicated in the symptoms
- •Patients eligible for AIT (patients who had been treated with AIT in the 3 years prior to the inclusion visit could be included if starting a new form and/or type of AIT)
- •Patients previously treated with a pharmacological AR treatment in the month before the inclusion visit or during the previous pollen season, and requiring the initiation of AIT
- •Patients (and/or their parents or legal representatives as appropriate) agreeing to take part in the study after having been informed orally and in writing by the observing physician.
排除标准
- •Patient with a hypersensitivity (allergy) to any of the excipients in the selected AIT
- •Patients taking beta-blockers (including local treatments, e.g. eye drops)
- •If asthmatic patient:
- •Patients with uncontrolled (unstable) or severe asthma (in adults this was defined as daily symptoms and FEV1 <70% of the theoretical value after appropriate drug treatment, and in children and adolescents by FEV1 <80% of the theoretical value after appropriate drug treatment)
- •Patients who have had a severe asthma exacerbation in the last three months
- •Asthmatic patient with unresolved acute infection of the airways.
结局指标
主要结局
PBQ (Patient Benefit Questionnaire)
时间窗: V1 / V2 (6, 9 or 12 months after treatment initiation)
The Patient Benefit Questionnaire (PBQ) was used as the primary endpoint to evaluate the benefits perceived by patients.
次要结局
- PNQ (Patient Need Questionnaire)(V1 (at study inclusion))
- PBI Patient Benefit Index(Patient self-questionnaires returned at V1 (at study inclusion) and V2 (6, 9 or 12 months after treatment initiation))