NCT03883984

Cysteamine for Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Cysteamine Bitartrate	Cysteamine bitartrate administered four times per day (QID) for 8 weeks. 125mg tablet QID.
DRUG	Placebo Oral Tablet	Placebo administered for 8 weeks. 125mg tablet QID.

Timeline

• Start date: 2019-06-18
• Primary completion: 2021-02-10
• Completion: 2021-02-10
• First posted: 2019-03-21
• Last updated: 2021-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study