RAPP-children, Rhinitis & Asthma in Patient Perspective: Development and Validation of a Questionnaire for Quality of Life Evaluation in Children With Asthma and Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- RAPP-children response patterns
研究概览
简要总结
This observational study aims at developing and validating a simple questionnaire to be routinely applied in the clinical practice, for the evaluation of the quality of life in children with concomitant asthma and allergic rhinitis. The study consists of two phases:
Phase 1: Development of the RAPP-children questionnaire starting from the validated RHINASTHMA-children questionnaire.
Phase 2: Administration and validation of the RAPP-children questionnaire. 150 children with concomitant asthma and allergic rhinitis will be followed-up for one month. Both at baseline and after one month, the RAPP children and several other standardized questionnaires will be administered.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 and 11 years
- •Concomitant asthma and allergic rhinitis
- •Males and Females
排除标准
- •Immunological and metabolic systemic disease
- •Major malformations of the upper airways
- •Active smoker
结局指标
主要结局
RAPP-children response patterns
时间窗: 1 months
Multivariate analyses of the responses to the RAPP-children questions
次要结局
- RHINASTHMA-children response patterns(1 months)
- C-ACT response patterns(1 months)
- VAS response pattern(1 months)
- Kiddy-KINDL response patterns(1 months)
- Pulmonary function: FEV1(1 months)
- Pulmonary function: FVC(1 months)
- Pulmonary function: FEF25-75(1 months)
研究者
Stefania La Grutta, MD
MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Istituto per la Ricerca e l'Innovazione Biomedica