Ignite Creation Date:
2024-05-05 @ 11:25 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01329172
Status:
TERMINATED
Last Update Posted:
2017-12-22
First Post:
2010-05-21
Brief Title:
Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis CF Patients
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOSTRIL
Brief Summary:
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 gday 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
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 gday 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-014869-43 | EUDRACT_NUMBER | None | None |