A prospective, randomized, open-label, parallel-group study to assess the efficacy and safety of Aeroguard 4S in paediatric asthma
试验速览
- 阶段
- 不适用
- 状态
- Other
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- 1. Change in frequency of short-acting β2-agonist use per week for relief of asthma symptoms from baseline to Day 90.
研究概览
简要总结
This is a prospective, randomized, open-label, parallel-group study to assess the efficacy and safety of Aeroguard 4S in paediatric asthma.
The study will be conducted in approximately 64 subjects, between 6-15 years of age (extremes included), with well controlled mild to moderate asthma as per GINA, 2016.
In order to assess the efficacy of Aeroguard 4S in reducing asthma symptoms, subjects in both the test and control arms will be monitored for asthma symptom control, lung function tests (LFTs), asthma exacerbations, and use of reliever and controller asthma medications.
Safety of the Aeroguard 4S will also be evaluated. Any AE experienced by the subjects during the 90-day study period will be recorded, assessed, reported, and followed-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children (boy or girl), 6-15 years of age (both inclusive);
- •Diagnosed with mild to moderate asthma, as per GINA, 2016, at least 1 year prior to the screening visit (See Appendix 1 for definition of mild to moderate asthma, as per GINA, 2016);
- •Well-controlled on current asthma medication at least 1 month prior to screening;
- •Resides within the geographical area of the study site so that home visits for installation, repair, and uninstallation of Aeroguard 4S are feasible;
- •Sleeps/spends at least approximately 8 hours per day for at least 5 days per week in a room in which the Aeroguard 4S is proposed to be installed.
- •Have no plans to relocate from the current residential accommodation in the next 3-4 months;
- •Has uninterrupted power supply to ensure continuous working of Aeroguard 4S;
- •Subject ≥7 years of age able to understand and comply with the study procedures (in the opinion of the investigator), and willing to sign the Assent Form; 9.
排除标准
- •Subject has lung disease other than asthma, as noted on history or chest x-ray performed at screening, if required;
- •Subject has any condition (including history or presence of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, rheumatologic, psychiatric, metabolic disturbances, or any other significant medical condition) that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit or confound the protocol-specified assessments;
- •Subject has a functioning air purifier already installed at home.
- •The subject is currently participating, or has participated in a drug/device study within a period of 30 days prior to screening.
结局指标
主要结局
1. Change in frequency of short-acting β2-agonist use per week for relief of asthma symptoms from baseline to Day 90.
时间窗: 90 days
2. Change in the LFTs (FVC, FEV1, and FEV1/FVC) from baseline to Day 45 and Day 90.
时间窗: 90 days
3. Proportion of children requiring modification (increase/decrease) in dose of inhaled corticosteroids at Day 90 from baseline.
时间窗: 90 days
4. Proportion of children with mild-moderate, severe, and life-threatening asthma exacerbation (defined as per GINA, 2016) over 90 days between study groups.
时间窗: 90 days
次要结局
- 1. Caregiver-reported outcomes to assess over 90 days.(2. Proportion of children with well-controlled asthma based on C-ACT score)