Treatment of patients with cystic fibrosis with N-acetylcysteine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001401-15-DK

Enrollment

Unknown

Registered

2010-04-14

Start date

2010-05-21

Completion date

Unknown

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with cystic fibrosis and chronic Pseudomonas lung infection MedDRA version: 12.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung

Interventions

Trade Name: ACC600Tabs Product Name: N-acetylcystein Product Code: R05C B01 Pharmaceutical Form: Tablet INN or Proposed INN: ACETYLCYSTEINE CAS Number: 616-91-1 Concentration unit: mg milligram(s) Con

Eligibility

Sex/Gender

All

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: pilotstudy to investigate level and individual variation of oxidative stress markers and effect of one month treatment on these variables on the lung fundtion;Secondary Objective: results will be used for power calculation for a large clinical study;Primary end point(s): 1. Oxidative stress markers (MDA, 8oxodG in urine) 2. Antioxidant status: vit C, oxidised vit C, a- og g-tokoferol, b-caroten, lycopen, plasma oxidazibility.	—

Measure

Time frame

Main Objective: pilotstudy to investigate level and individual variation of oxidative stress markers and effect of one month treatment on these variables on the lung fundtion;Secondary Objective: results will be used for power calculation for a large clinical study;Primary end point(s): 1. Oxidative stress markers (MDA, 8oxodG in urine) 2. Antioxidant status: vit C, oxidised vit C, a- og g-tokoferol, b-caroten, lycopen, plasma oxidazibility.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026