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Clinical Trial Summary

The purpose of this study is to see if a medicine called Cysteamine, given along with standard asthma care, will improve asthma symptoms and lung function.


Clinical Trial Description

Asthma affects 25.7 million people in the US. Many people report symptoms despite taking high-doses of inhaled asthma medications. This difficult-to-treat group accounts for more than 50% of asthma related healthcare visits and hospitalizations. The purpose of this study is to see if a medicine called Cysteamine, given along with standard asthma care, will improve asthma symptoms and lung function. This study is a double-blind, placebo-controlled, randomized trial of cysteamine. A placebo arm will be included to determine the comparative effectiveness of cysteamine in this population. Eligible participants will be assessed 1, 4 and 8 weeks post randomization and followed for an additional 4 weeks post treatment. In order to enroll in this study, participants must be between the ages of 18-45 and have uncontrolled asthma. This study will include 4 visits and weekly phone calls, and will be in the study for 3-4 months. During the treatment period, participants will be placed in one of two treatment groups: - Cysteamine - Placebo Participants will not be able to choose which group they are assigned. This assignment is random and by chance, much like flipping a coin. Participants will not know if they are receiving Cysteamine or placebo. Investigators will compare the study results between the participants of each group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03883984
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact
Status Completed
Phase Phase 1
Start date June 18, 2019
Completion date February 10, 2021

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