Cystic FibrosisNOSTRILNCT01329172
Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis (CF) Patients
A study testing polyunsaturated fatty acids n-3 in people with Cystic Fibrosis and Dietary Modification, run by University Hospital, Lille at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Cystic Fibrosis, Dietary Modification
- What is being tested?
- polyunsaturated fatty acids n-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Sep 2010to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cystic fibrosis patient
- Aged 18 to 30 year
- No modification of long term therapy (Corticoids, antibiotics, pancreatic extract, antiacid) before 4 weeks before randomization
Who cannot join
- Awaiting transplantation
- Patients on anticoagulants
- Contraindication to supplementation with polyunsaturated fatty acids
- Taking antibiotics in progress ( less than 15 days)
- Taking anti- inflammatory ongoing (more than one week per month , steroids , or nonsteroidal )
Trial locations and contacts
3 sites in 1 country.
France3 sites
Dunkerque Hospital
Dunkirk
Lens Hospital
Lens, 62300
Clinical Investigation center
Lille, 59037
About this study
Official title: Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients
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.
Read more
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.
Read the 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
- Conditions
- Cystic Fibrosis, Dietary Modification
- Being tested
- polyunsaturated fatty acids n-3, placebo
- Keywords
- PUFA, Cystic Fibrosis, Nasal brushing, Mucins, Mucin production
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyunsaturated fatty acids n-3Other
Also called PUFA n-3
polyunsaturated fatty acids n-3 1 gram per day during two months
placeboOther
Also called PUFA
sun flower oil with Poly Unsaturated Fatty Acid 1g/day
| Study group | Role | What they receive |
|---|---|---|
| polyunsaturated fatty acids n-3 | Experimental | polyunsaturated fatty acids n-3 (PUFA n-3) Receives: Other: polyunsaturated fatty acids n-3 |
| placebo | Placebo comparator | sun flower oil Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of Mucin "MUC5B" by measurement of messenger Ribo Nucleic Acid (mRNA) level in native airway epithelial cells obtained by nasal brushing
Measured: baseline and 2 months
Secondary outcomes (1)
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
Measured: baseline and two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study start20 Sep 2010
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric GOTTRAND, MD, PhD, Study chair, CHRU de Lille et Université Lille 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329172
- Sponsor's protocol ID
- 2008_47/0928
- Other IDs
- 2009-014869-43, 2009
- Acronym
- NOSTRIL
- Status last verified
- Dec 2017
- First submitted
- 21 May 2010
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT01329172
- Acronym / sponsor ID
- NOSTRIL / 2008_47/0928
- Conditions
- Cystic Fibrosis, Dietary Modification
- Keywords
- PUFA, Cystic Fibrosis, Nasal brushing, Mucins, Mucin production
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 20 Sep 2010 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 5 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyunsaturated fatty acids n-3 | Experimental | Other: polyunsaturated fatty acids n-3polyunsaturated fatty acids n-3 (PUFA n-3) |
| placebo | Placebo comparator | Other: placebosun flower oil |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cystic fibrosis patient
- Aged 18 to 30 year
- No modification of long term therapy (Corticoids, antibiotics, pancreatic extract, antiacid) before 4 weeks before randomization
Key exclusion criteria (5 listed)
- Awaiting transplantation
- Patients on anticoagulants
- Contraindication to supplementation with polyunsaturated fatty acids
- Taking antibiotics in progress ( less than 15 days)
- Taking anti- inflammatory ongoing (more than one week per month , steroids , or nonsteroidal )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyunsaturated fatty acids n-3Also: PUFA n-3polyunsaturated fatty acids n-3 1 gram per day during two months | Other | polyunsaturated fatty acids n-3 |
| placeboAlso: PUFAsun flower oil with Poly Unsaturated Fatty Acid 1g/day | Other | placebo |
Primary outcome
Expression of Mucin "MUC5B" by measurement of messenger Ribo Nucleic Acid (mRNA) level in native airway epithelial cells obtained by nasal brushing
Time frame: baseline and 2 months
1 secondary outcome
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
Time frame: baseline and two months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric GOTTRAND, MD, PhD study chair
CHRU de Lille et Université Lille 2
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyunsaturated fatty acids n-3 in people with Cystic Fibrosis and Dietary Modification, run by University Hospital, Lille at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of Mucin "MUC5B" by measurement of messenger Ribo Nucleic Acid (mRNA) level in native airway epithelial cells obtained by nasal brushing (time frame: baseline and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.