Biochemical effects of a long-term supplementation with omega-3 polyunsaturated fatty acids in cystic fibrosis - Omega 3 study

Conditions: cystic fibrosis
MedDRA version: 8.1Level: LLTClassification code 10011762Term: Cystic fibrosis

Registration Number: EUCTR2006-004155-38-BE

Lead Sponsor: Hôpital Universitaire Des Enfants Reine Fabiola (H.U.D.E.R.F.)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 80

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

- 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 < 50.000/mm³, treatment by anticoagualant or antiplatelets agents, disturbances of haemostasis with PT < 70%)
- patient with significant liver disease (liver function tests with values 2-fold higher than normal range) or having abnormal liver echography such as signs of cirrhosis
- hypercholesterolemia (> 240 mg)
- patient is pregnant or breast-feeding mother