High dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urine
Phase 1
- Conditions
- cystic fibrosisMedDRA version: 19.0Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-000354-35-DK
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Unstable clinical condition
Unable to perform reliable LFT
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): improvement of inflammatory parameters;Timepoint(s) of evaluation of this end point: 7 and 14 days