RISKA: Respiratory Irritability With School Kids With/Without Asthma - Assessment of Methacholine Responsiveness in Pediatric Asthma: A Comparative Study With Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- BHR and asthma balance
研究概览
简要总结
The study includes a pre-study telephone interview with healthy controls to assess their eligibility for participation. During the study visit, a background information form and an asthma questionnaire are completed. At the study visit, a methacholine challenge test measuring airway hyperresponsiveness and an exhaled nitric oxide measurement are performed. The effect of medication intensification in asthma patients is further assessed through a telephone interview 1-2 months after the medication adjustment.
详细描述
Study type: Observational study Study sites: Skin and Allergy Hospital, Helsinki, Finland Inclusion criteria: Age 7-15 years, diagnosed with asthma and on regular asthma medication with physician-assessed good asthma control (55 participants), suboptimal asthma control (55 participants), or healthy controls with no inhaled asthma medication or asthma-related symptoms in the preceding two years (150 participants).
Exclusion criteria: Other respiratory, cardiovascular, or neurological diseases; acute respiratory infection within 2 weeks; respiratory disorders related to prematurity; implanted or external active medical devices.
Sample size: 110 asthma patients and 150 healthy controls. Study duration: Until the end of 2027 Study visits: One study visit; in addition, consent will be sought to contact participants during the 15-year storage period of the study data, for example, regarding questionnaire follow-ups.
Objectives:
Primary:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Controls
- •• Aged 7-15 years, both sexes
- •No diagnosis of asthma in childhood
- •No inhaled asthma medication during the previous 2 years
- •No wheezing or shortness of breath during the previous 2 years
- •Written informed consent from the participant and guardian
- •Inclusion Criteria: Children with Asthma
- •Aged 7-15 years, both sexes
- •Physician-diagnosed asthma (ICD-10 codes J45.0/J45.1/J45.9)
- •Inhaled corticosteroid treatment for at least 6 months
- •Well-controlled asthma (c-ACT/ACT score ≥20) and no clinical need to intensify medication, or
- •Poorly controlled asthma with physician-confirmed need for intensified asthma medication
排除标准
- •• Premature birth before 32 gestational weeks
- •Other chronic cardiopulmonary or neurological conditions affecting airways (excluding asthma)
- •Severe underlying illness such as malignancy
- •Beta-blocker medication
- •Active immunological disease
结局指标
主要结局
BHR and asthma balance
时间窗: Baseline
To determine whether airway hyperresponsiveness (defined as cumulative dose of methacholine causing 20% fall of FEV1 (PD20FEV1)) differs clinically significantly (PD20FEV1 at least twofold difference) between children with well-controlled asthma, those requiring intensified asthma medication, and healthy controls
FeNO in study groups
时间窗: Baseline
To determine whether a corresponding difference exists in exhaled nitric oxide levels between the groups
次要结局
- Age and BHR(Baseline)
- Allergic sensitization and BHR(Baseline)
- Eosinophils and BHR(Baseline)
研究者
Janne Burman
PhD, MD, Pediatric Allergist
Helsinki University Central Hospital