High dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urine

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000354-35-DK

Enrollment

Unknown

Registered

2016-02-10

Start date

2016-05-12

Completion date

Unknown

Last updated

2017-03-13

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

Conditions

cystic fibrosis MedDRA version: 19.0 Level: LLT Classification code 10068288 Term: Cystic fibrosis pulmonary exacerbation System Organ Class: 100000004862

Interventions

Trade Name: Mucolysin Pharmaceutical Form: Effervescent tablet INN or Proposed INN: ACETYLCYSTEINE SODIUM Concentration unit: mg milligram(s) Concentration type: range Concentration number: 200-6oo T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cystic fibrosis genotype and FVC above 40 % Clinically stable patients NO antibiotics or antiinflammatory treatment prior to or under trial Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no 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: Unstable clinical condition Unable to perform reliable LFT

Design outcomes

Primary

Measure	Time frame
Main Objective: to evalutate if high dose antioxidant treatment ( per oral) can inhibit the oxaditive stress mediated inflammation in cystic fibrosis;Secondary Objective: not applicable;Primary end point(s): Decreased urinary excretion of desmosine/isodesmosine after end of trial;Timepoint(s) of evaluation of this end point: after 7 and 14 days	—

Secondary

Measure	Time frame
Secondary end point(s): improvement of inflammatory parameters;Timepoint(s) of evaluation of this end point: 7 and 14 days	—

Countries

Denmark

Contacts

Public ContactPaediatric Department

Aarhus University Hospital

peschi@rm.dk+4578451471

Outcome results

None listed

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