Status:
COMPLETED
First Study of Oral Cysteamine in Cystic Fibrosis
Lead Sponsor:
University of Aberdeen
Collaborating Sponsors:
Cystic Fibrosis Trust
NHS Grampian
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The morbidity and mortality associated with Cystic Fibrosis (CF) are the result of chronic suppurative lung disease. The aggressive use of antibiotics is one of the mainstays of treatment in CF, howev...
Detailed Description
Cystic Fibrosis (CF) is the commonest fatal inherited disease in Caucasian populations of European origin. The morbidity and mortality associated with CF are the result of chronic suppurative lung dis...
Eligibility Criteria
Inclusion
- CF related suppurative lung disease who expectorate sputum,
- Clinically stable for \>4 weeks,
- Aged ≥18 years,
- Weight \>50kg,
- Female participants of child bearing potential should be using a reliable form of contraception.
Exclusion
- Hypersensitivity to the active substance, any form of cysteamine, or to any of the excipients.
- Hypersensitivity to penicillamine.
- Lung, liver transplant, on active transplant list.
- For women, current pregnancy or breast-feeding, or planned pregnancy during the study.
- Any other significant disease/disorder which, in the investigator's opinion, either puts the patient at risk because of study participation or may influence the results of the study or the patient's ability to participate in the study.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02212431
Start Date
August 1 2014
End Date
April 1 2015
Last Update
November 5 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN