A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations

Details

Therapeutic category
Mucociliary Clearance
Trial status
Completed Participating Centres
Phase
Phase II

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

This 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.
Trial Reference Number
101870
Trial type
Medication
Length of participation
3 weeks
Intervention
Cysteamine (mucolytic agent)
Recruitment target
120
Last edited date
30/08/2019
CF sponsor
Novabotics
CF sponsor type
Commercial

Who can take part?

Age
18+
Top inclusion criteria
  • 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
Top exclusion criteria
  • Hypersensitive to cysteamine or to any of the excipients
  • Hypersensitive to penicillamine
  • Transplant recipient

Your donation will make a difference:

Select amount