cystic fibrosis MedDRA version: 8.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Conditions
Interventions
Product Name: Omega 3 Premium
Pharmaceutical Form: Capsule, soft
Other descriptive name: OMEGA-3-ACID TRIGLYCERIDES
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number:
Sponsors
Hôpital Universitaire Des Enfants Reine Fabiola (H.U.D.E.R.F.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Clinically stable cystic fibrosis patient - patient treated by zitromax with stable dose since 3 months - documented homozygous for deltaF 508 mutation - male or female patient aged 6 or older - patient able to perform pulmonary function test - patient able to swallow capsules - female patient of childbearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study. Are the trial subjects under 18? yes 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: - ongoing acute illness invcluding acute upper or lower respiratory infections within 2 weeks before start of study medication. - abnormalities on screening chest X-Ray or CT Scan suggesting clinically active pulmonary disease other than CF, or new significant abnormalities such as atelectasis or pleural effusion wihich may be indicative of clinically active pulmonary involvement secondary to CF. - any oral or intravenous inflammatory treatment other than azitromicine or NSAIDs given to the patient within 3 months before start of study treatment. - patient with active bleeding or increased risk of bleeding (rate of platelets 240 mg) - patient is pregnant or breast-feeding mother
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether there is evidence that omega-3 essential fatty acids (EFA) oral supplementation has beneficial effects in patients with cystic fibrosis.;Secondary Objective: To identify any adverse side effects associated with omega-3 EFA oral supplementation;Primary end point(s): Reduction of inflammatory factors (LTB4/LTB5 ratio) from baseline to end of treatment | — |
Countries
Belgium
Outcome results
None listed