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临床试验/CTRI/2026/01/100519
CTRI/2026/01/100519尚未招募不适用

Budesonide/formoterol Maintenance and Reliever Therapy (MART) versus budesonide/formoterol plus as-needed salbutamol in children 6-11 years with asthma: A Randomized Control Trial

All India Institute of Medical Sciences Jodhpur1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2026年2月3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
98
试验地点
1

研究概览

简要总结

Asthma is the most common chronic respiratory condition of childhood worldwide. Current treatment recommended by guidelines in persistent asthma is fixed-dose inhaled corticosteroids (ICS) or ICS/LABA (long acting beta agonist) combination with as needed short acting beta-agonist (SABA). A novel approach is budesonide/formoterol Maintenance and Reliever Therapy (MART) using single inhaler, without requirement of SABA. Studies have shown MART is more effective at reducing exacerbations and improving daily asthma control than the same maintenance dose of budesonide/formoterol plus as needed SABA. Lacunae in existing literature- Paucity in existing literature comparing Budesonide/formoterol as MART versus Budesonide/formoterol plus as needed salbutamol as controller options in children 6-11 years with asthma.

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 11.00 Year(s)(—)
性别
All

入选标准

  • GINA step 3 asthma.

排除标准

  • Chronic lung disease ~ BPD Congenital thoracic malformations Airway malacia Mucociliary dysfunction- Cystic fibrosis, primary ciliary dyskinesia History of recent exacerbation requiring oral/IM/IV corticosteroid in last 4 weeks.

研究者

发起方
All India Institute of Medical Sciences Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sathya Srivatsav

AIIMS Jodhpur

研究点 (1)

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