A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.

Phase 1

• Conditions: exacerbation of Cystic Fibrosis; MedDRA version: 19.0Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-004986-99-IT
• Lead Sponsor: ovaBiotics, Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-06
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. CF-associated lung disease with documented history of chronic infection with Gram-negative organism(s)
2. Established patient of the Principal Investigator's CF Multi-Disciplinary team
3. Age equal or greater than 18 years
4. Weight equal or more than 40 Kg
5. FEV1 more than 30% of predicted within the 6 months prior to study exacerbation
6. At baseline visit: experiencing a new exacerbation of CF associated lung disease requiring treatment that includes an aminoglycoside antibiotic
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Hypersensitive to cysteamine or to any of the excipients
2. Hypersensitive to penicillamine
3. Transplant recipient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified