Treatment of patients with cystic fibrosis with N-acetylcysteine

Phase 1

• Conditions: Patients with cystic fibrosis and chronic Pseudomonas lung infection; MedDRA version: 12.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung

• Registration Number: EUCTR2007-001401-15-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-14
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adults (18-50 yrs).

2. Male and female. No fertile women - negative pregnancy test - use anticonception)

3. Patients are included at the end of a routine 2 wk antibiotic course

4. Included patients are caucasians

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Hypersensitivity to ACC
2.Lung transplanted patients or patients waiting for LTX
3.Patients not treated with ACC 30 days before inclusion
4.Lack of compliance.
5.Patients with recent hemoptysis (within 14 days).
6.Patients with increased liver enzymes i.e. ALAT more than twice normal values (10-70U/L).

Study & Design

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