2024-513916-84-00已完成3 期
A prospective multicenter placebo-controlled trial to study the efficacy and safety of Tiotropium in preventing severe asthma exacerbations in partial and uncontrolled preschool asthma.
Goethe University Frankfurt, Goethe University Frankfurt12 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2024年6月5日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 12
- 主要终点
- Time to first severe exacerbations, defined by hospitalization and/or at least 3 days of systemic steroids or one day of rectal prednisolone (Rectodelt®).
研究概览
简要总结
The primary objective is to evaluate whether addition of Tiotropium via Respimat® to ICS prevents severe asthma exacerbations.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female patients with preschool asthma aged between 1 and 5 years (< 6 at visit 1). In addition, age-appropriate assent in accordance with local regulations or guidelines or both before enrolment in the study and prior to the beginning of any study-specific procedures will be obtained from the child.
- •Physician diagnosed asthma of at least 6 months' history of asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath.
- •All patients must have been on maintenance treatment with an ICS at a stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before visit
- •Patient was hospitalized due to acute severe asthma and/or was treated with at least 2 courses of systemic steroids (three days of oral steroids or one day of rectal prednisolone 100mg (Rectodelt®)) in the last 24 months before visit
- •All patients must be symptomatic (partly controlled or uncontrolled) as defined by the GINA guideline for children aged 5 years and younger in the four weeks prior to screening (visit 1) and randomization (visit 2) despite treatment with ICS (visit 1 and visit 2).
- •Patients must be able to inhale from the Respimat® inhaler (with a spacer).
排除标准
- •Patients with a significant disease other than asthma such as, but not limited to, the following diagnoses: cystic fibrosis, bronchopulmonary dysplasia, primary immunodeficiency, congenital heart disease, parasitic disease, and foreign body aspiration.
- •Patients with clinically relevant abnormal screening hematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion.
- •Patients with known hypersensitivity to anticholinergic drugs, or any other components of the Tiotropium inhalation solution.
- •Patients with any severe acute asthma exacerbation or severe respiratory tract infection defined by systemic steroid intake or hospitalization in the four weeks prior to visit 1.
结局指标
主要结局
Time to first severe exacerbations, defined by hospitalization and/or at least 3 days of systemic steroids or one day of rectal prednisolone (Rectodelt®).
Time to first severe exacerbations, defined by hospitalization and/or at least 3 days of systemic steroids or one day of rectal prednisolone (Rectodelt®).
次要结局
- number of severe exacerbations
- number of hospitalizations (severe exacerbation)
- (severe) exacerbation-free survival time
- number of asthma-related events defined by use of antibiotics
- percentage of night-time awakenings due to asthma symptoms as assessed by the electronic patients diary/PACD
- percentage of days without asthma symptoms assessed by TIPP diary App (PACD)
- percentage of days and episodes of > 3 days with use of PRN salbutamol rescue medication
- health utilization (number of physician visits)
- number of missed days in daycare
- result of TRACK
- CGI-C at end of treatment and potential biomarkers for treatment response
- Eosinophils, IgE, specific IgE to common allergens (birch, grass, Dermatophagoides pteronyssinus, Alternaria, Cladosporium, cat, dog, hen's egg, cow's milk and peanut
- Assessment of safety: Safety will be ensured by analysis of symptom scores and rescue medication use by the electronic diary, and adverse events (AEs).
研究者
TIPP LKP Zentrum
Scientific
Goethe University Frankfurt
研究点 (12)
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