A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations
Details
- Therapeutic approach
- Mucociliary Clearance
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001821
- Last updated
- 30/08/2019
Full title
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients Being Treated for an Exacerbation of CF-associated Lung Disease
Study detailsThis study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis who are experiencing an exacerbation of CF-associated lung disease. There are six different potential dosing regimens, including one that is placebo.
- Phase
- Phase 2
- Length of participation
- 3 weeks
- Recruitment target
- 120
- CF sponsor
- Novabotics
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 18+
- Including people
Age 18 years or older
CF-associated lung disease with history of chronic infection
FEV1 >30% of predicted within the 6 months prior
At the baseline visit: experiencing a new exacerbation of CF-associated lung disease requiring treatment- Excluding people
Hypersensitive to cysteamine or to any of the excipients
Hypersensitive to penicillamine
Transplant recipient
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