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临床试验/CTRI/2025/09/094687
CTRI/2025/09/094687尚未招募不适用

Comparing the clinical efficacy of breath actuated inhalers versus metered dose inhalers with spacer in children and adolescents with asthma

Government Medical College and Hospital Chandigarh1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Change in FEV1 percent of expected from baseline

研究概览

简要总结

Asthma is a major cause of disease burden in Asian children including India where its prevalence is 7.9 percent. Despite therapeutic advances asthma control remains poor especially in low and middle income countries due to limited access to care. Inhaled medications like corticosteroids are key to treatment but effectiveness depends on proper inhaler technique. Metered Dose Inhalers MDIs with spacers are commonly recommended for children but have drawbacks including bulkiness and stigma which may reduce adherence. Breath actuated inhalers BAIs such as Synchro Breathe may improve drug delivery by removing the need for hand breath coordination. However their efficacy in children particularly in India is not well studied.

This randomized controlled trial will compare BAIs and MDIs with spacers in children aged 6 to 18 years at a tertiary hospital in Chandigarh. A total of 70 children will be enrolled and stratified by age. Both groups will receive identical drug formulations. Lung function FEV1 spirometry patient diaries and validated questionnaires will be used. The findings aim to provide evidence based guidance for selecting the most effective and user friendly inhaler devices for pediatric asthma management in resource limited settings.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children aged 6 to 18 years with asthma diagnosed according to criteria in GINA 2024 Only patients requiring daily inhaled corticosteroids as controller.

排除标准

  • Acute exacerbation at enrolment Comorbid conditions affecting lung function eg cystic fibrosis ABPA Unable to perform spirometry Patients unlikely or unwilling to come for followup visits as planned.

结局指标

主要结局

Change in FEV1 percent of expected from baseline

时间窗: 12 weeks

次要结局

  • Proportion of patients with asthma controlled, partly controlled or uncontrolled(2 4 12 weeks)
  • Change in PEFR from baseline(2 4 12 weeks)
  • Proportion of missed doses in previous 4 weeks(4 weeks)
  • Proportion of steps correctly performed(2 4 12 weeks)

研究者

发起方
Government Medical College and Hospital Chandigarh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Tamanna Sharma

Government Medical College and Hospital, Chandigarh

研究点 (1)

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