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Clinical Trial Summary

This study is a 24-week, randomized, parallel group comparative effectiveness study to evaluate the risk of stepping down therapy for patients with well-controlled asthma treated with combination Inhaled corticosteroids (ICS) and Leukotriene receptor antagonist(LTRA).


Clinical Trial Description

Asthma guidelines recommend stepping down therapy once asthma is controlled for at least 3 months. Leukotriene receptor antagonist(LTRA). For children with mild persistent asthma, ICS twice a day combined with LTRA can be used for treatment, but there is no consensus on how to reduce drugs in patients with asthma that is well controlled (reducing the dose of ICS or stopping montelukast). We propose a 24-week, randomized, parallel group comparative effectiveness study comparing three approaches in patients with asthma well-controlled for at least three months on combination ICS and LTRA: Halve the dose of ICS firstly and then stop ICS with montelukast only, stop montelukast firstly and then halve the dose of ICS, and halve the dose of ICS firstly and then stop montelukast. Our goal is to compare the rate of treatment failure and determine the optimal treatment strategy. Additional goals include assessing risk factors for step-down failure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04953741
Study type Interventional
Source Xijing Hospital
Contact Xin Sun, doctor
Phone +8613572536262
Email sunxin6@fmmu.edu.cn
Status Not yet recruiting
Phase Phase 4
Start date August 1, 2021
Completion date August 1, 2022

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