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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-014869-43 | EudraCT Number |
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Background :
Cystic fibrosis (CF) patients are prone to recurrent pulmonary infection have different secreted mucin pattern from healthy subjects. Long chain polyunsaturated fatty acids have been shown to influence survival and MUC5B expression in mice model of chronic pulmonary infection.
Method :
To study the impact of LCPUFA n-3 on MUC5B expression (mRNA level by RT-PCR) collected in airway epithelial cells obtained by nasal brushing. The secondary aim is to assess : MUC1, MUC2, MUC4, MUC5AC, MUC7 expression (mRNA level) in airway epithelial cells obtained by nasal brushing; Lund-Kennedy score; TNK-alpha, IL-6, IL-8 in blood plasma. This study is a double parallel, controlled double blind, randomized clinical trial : LCPUFA n-3 (1 g/day) vs placebo for 6 weeks. 30 subjects will be included in this study. Primary and secondary study end point will be assessed two times: before randomization and after 60 days of treatment.
Statistical analysis :
Treatment group and placebo will be compared using U-Mann-Whitney, intention to treat and per protocol.
Primary Outcome Measure : Mucin MUC5B (mRNA level) in native airway epithelial cells obtained by nasal brushing
Secondary Outcome Measures : Mucin MUC1, MUC2, MUC4, MUC5AC, MUC7 (mRNA level) in native airway epithelial cells obtained by nasal brushing.
Lund-Kennedy score TNF-alpha, IL-6, IL-8 in plasma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polyunsaturated fatty acids n-3 | Experimental | polyunsaturated fatty acids n-3 (PUFA n-3) |
|
| placebo | Placebo Comparator | sun flower oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyunsaturated fatty acids n-3 | Other | polyunsaturated fatty acids n-3 1 gram per day during two months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Expression of Mucin "MUC5B" by measurement of messenger Ribo Nucleic Acid (mRNA) level in native airway epithelial cells obtained by nasal brushing | baseline and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mucin MUC1, MUC2, MUC4, MUC5AC, MUC7 (mRNA level) in native airway epithelial cells obtained by nasal brushing. Lund-Kennedy score TNF-alpha, IL-6, IL-8 in plasma | baseline and two months |
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Inclusion Criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric GOTTRAND, MD, PhD | CHRU de Lille et Université Lille 2 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dunkerque Hospital | Dunkirk | France | ||||
| Lens Hospital |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| placebo | Other | sun flower oil with Poly Unsaturated Fatty Acid 1g/day |
|
|
| Lens |
| 62300 |
| France |
| Clinical Investigation center | Lille | 59037 | France |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |