High Dose Antioxidant Treatment for Patients with Cystic Fibrosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005481-19-DK

Enrollment

Unknown

Registered

2014-05-27

Start date

2014-05-27

Completion date

Unknown

Last updated

2016-05-23

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

Conditions

Cystic Fibrosis MedDRA version: 17.0 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 Other descriptive name: ACETYLCYSTEINE Concentration unit: mg milligram(s) Concentration type: range

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: CF patients with verified genotype and FEV1 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: 10 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 evaluate if high dose antioxdant treatment (per oral and inhalation) can inhibit the oxidativ stress mediated inflammation in cystic fibrosis patients lung. The inflammation with neutrophil leucocytes is monitored by Pet/CT scan;Secondary Objective: None;Primary end point(s): Diminished neutrophil inflammation measured by pet/ct scan;Timepoint(s) of evaluation of this end point: After 10 days of treatment	—

Measure

Time frame

Main Objective: To evaluate if high dose antioxdant treatment (per oral and inhalation) can inhibit the oxidativ stress mediated inflammation in cystic fibrosis patients lung. The inflammation with neutrophil leucocytes is monitored by Pet/CT scan;Secondary Objective: None;Primary end point(s): Diminished neutrophil inflammation measured by pet/ct scan;Timepoint(s) of evaluation of this end point: After 10 days of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Improvement in inflammatory parameters (CRP, neutrophil blood count) Improvement in LFT and neg culture for chronically infected patients;Timepoint(s) of evaluation of this end point: After 10 and 17 days of treatment	—

Countries

Denmark

Contacts

Public ContactPediatric Department A

Aarhus University Hospital

peschi@rm.dk

Outcome results

None listed

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