Cystic FibrosisMod2EpiCFNCT01883284
Action of Epigenetic Modifiers in Cystic Fibrosis Treatment
A study of Cystic Fibrosis and Healthy Subjects, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers effects firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors (IL-8, LXA4 and SCGB1A1) and mucines (MUC5AC and MUC5B)… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Healthy Subjects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Nov 2014
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 2 severe CF mutations
- age superior or equal to 12
- age superior or equal to 18
- no smoker (for 5 years)
- General exclusion criteria :
- participation to an other interventionnal study
Show all 22Show fewer
- subject in exclusion period
- law protected subject
- pregnant and breast fooding
- Specific Exclusion Criteria:
- Xylocaine hypersensibility
- Porphyria
- severe hepatic failure
- Epilepsy
- Severe cardiac failure
- local anesthesic contra indication
- Specific Control subject Exclusion Criteria:
- respiratory disease
- cystic fibrosis
- acute infection < 6 weeks
- on treatment
- antibiotic treatment < 3 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Action of Epigenetic Modifiers in Cystic Fibrosis Treatment: ex Vivo Model of Nasal Epithelium of CF Patients
Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers effects firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors (IL-8, LXA4 and SCGB1A1) and mucines (MUC5AC and MUC5B) in a dynamic epithelium model using an air-liquide interface culture of nasals cells from CF patients or controls.
- Conditions
- Cystic Fibrosis, Healthy Subjects
- Being tested
- Tests in vitro after sampling nasal cells of CF patients or controls
- Keywords
- Cystic Fibrosis, nasal epithelia, mucins
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tests in vitro after sampling nasal cells of CF patients or controlsOther
Nasal cells of CF patients or controls were collected by scratching of intermediate turbinate and cultured in vitro. Epigenetic modifiers treatment was applied to these ex vivo nasal epithelia. Then, mRNA, protein and secretions were quantified.
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis patients (CF) | Experimental | Tests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects Receives: Other: Tests in vitro after sampling nasal cells of CF patients or controls |
| Control subjects (non CF) | Other | Tests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects Receives: Other: Tests in vitro after sampling nasal cells of CF patients or controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment
Measured: 24 months
Secondary outcomes (3)
Pro-inflammatory cytokines number variations after epigenetic modifiers treatment
Measured: 24 months
Anti-inflammatory cytokines number variations after epigenetic modifiers treatment
Measured: 24 months
Mucin composition variations after epigenetic modifiers treatment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionNov 2014
- Study completionNov 2014
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, MontpellierThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphaël RC CHIRON, MD, Principal investigator, Arnaud de Villeneuve CHU Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883284
- Sponsor's protocol ID
- 8870
- Acronym
- Mod2EpiCF
- Status last verified
- Dec 2014
- First submitted
- 13 Jun 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Action of Epigenetic Modifiers in Cystic Fibrosis Treatment: ex Vivo Model of Nasal Epithelium of CF Patients
- ClinicalTrials.gov ID
- NCT01883284
- Acronym / sponsor ID
- Mod2EpiCF / 8870
- Conditions
- Cystic Fibrosis, Healthy Subjects
- Keywords
- Cystic Fibrosis, nasal epithelia, mucins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Jun 2013 (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.
Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers effects firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors (IL-8, LXA4 and SCGB1A1) and mucines (MUC5AC and MUC5B) in a dynamic epithelium model using an air-liquide interface culture of nasals cells from CF patients or controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis patients (CF) | Experimental | Other: Tests in vitro after sampling nasal cells of CF patients or controlsTests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects |
| Control subjects (non CF) | Other | Other: Tests in vitro after sampling nasal cells of CF patients or controlsTests in vitro after sampling nasal cells of CF patients or controls are the intervention done on these subjects |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- 2 severe CF mutations
- age superior or equal to 12
- age superior or equal to 18
- no smoker (for 5 years)
- participation to an other interventionnal study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Tests in vitro after sampling nasal cells of CF patients or controlsNasal cells of CF patients or controls were collected by scratching of intermediate turbinate and cultured in vitro. Epigenetic modifiers treatment was applied to these ex vivo nasal epithelia. Then, mRNA, protein and secretions were quantified. | Other | Control subjects (non CF), Cystic Fibrosis patients (CF) |
Primary outcome
Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment
Time frame: 24 months
3 secondary outcomes
Pro-inflammatory cytokines number variations after epigenetic modifiers treatment
Time frame: 24 months
Anti-inflammatory cytokines number variations after epigenetic modifiers treatment
Time frame: 24 months
Mucin composition variations after epigenetic modifiers treatment
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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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.
Raphaël RC CHIRON, MD principal investigator
Arnaud de Villeneuve CHU Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cystic Fibrosis and Healthy Subjects, run by University Hospital, Montpellier at 1 site 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 22 inclusion and 0 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: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment (time frame: 24 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 3 Dec 2014.