Cystic FibrosisPro-MucoNCT00750932
Biodistribution of Neutrophile Proteases in the Sputum of Patients Affected by Cystic Fibrosis
An observational study of Cystic Fibrosis, run by University Hospital, Tours at 1 site in France.
Trial summary
The purpose of the proposed project is to characterize the neutrophile proteases which participate in the chronic inflammatory phenomenon associated with the cystic fibrosis and which are responsible for the degradation of the lung tissue. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Jan 2012
- Phase
- Observational
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults and children with cystic fibrosis
Who may be able to join
- Man /woman older than 18 years (for adult and group)
- Child aged 6 to 18 years (for child group)
- Suffering from cystic fibrosis in stable condition, ie not having presented thrust acute attack of the broncho-pulmonary or hospitalization for treatment of his illness during the previous 2 weeks
Who cannot join
- colonized by Burkholderia cepacia ou Stenotrophomonas maltophilia
- non smoker (control group)
- Without history or respiratory respiratory disease known (control group)
- Antibiotic treatment and / or anti-inflammatory drug (NSAID or corticosteroids) in the 2 weeks prior to the inclusion in the study (control group)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Biodistribution of PMN Serine Proteases in Sputum of Patients Affected by Cystic Fibrosis: Towards New Anti-inflammatory Therapies
The purpose of the proposed project is to characterize the neutrophile proteases which participate in the chronic inflammatory phenomenon associated with the cystic fibrosis and which are responsible for the degradation of the lung tissue.
The respiratory failure which results from it is one of main causes of the fatal evolution of this pathology but the anti-inflammatory therapies based on the use of antiproteases targeting specifically the soluble elastase did not end, until now, in the hoped results.
The identification of the other noxious targets is a crucial element to give new orientations to the anti-inflammatory strategies based on the administration of antiproteases which remain a promising way.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T | Control | |
| M | Minor with cystic fibrosis | |
| A | Adult with cystic fibrosis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2012
- Study completionJan 2012
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, ToursThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice DIOT, PHD, Principal investigator, Tours Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750932
- Sponsor's protocol ID
- AOHP07-PD Pro-Muco
- Other IDs
- DGS2007-0295, N° ID RCB:2007-A00511-52, CPP: 2007-R17
- Acronym
- Pro-Muco
- Status last verified
- Feb 2017
- First submitted
- 10 Sep 2008
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Biodistribution of PMN Serine Proteases in Sputum of Patients Affected by Cystic Fibrosis: Towards New Anti-inflammatory Therapies
- ClinicalTrials.gov ID
- NCT00750932
- Acronym / sponsor ID
- Pro-Muco / AOHP07-PD Pro-Muco
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Sep 2008 (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.
The purpose of the proposed project is to characterize the neutrophile proteases which participate in the chronic inflammatory phenomenon associated with the cystic fibrosis and which are responsible for the degradation of the lung tissue.
The respiratory failure which results from it is one of main causes of the fatal evolution of this pathology but the anti-inflammatory therapies based on the use of antiproteases targeting specifically the soluble elastase did not end, until now, in the hoped results.
The identification of the other noxious targets is a crucial element to give new orientations to the anti-inflammatory strategies based on the administration of antiproteases which remain a promising way.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T | – | –Control |
| M | – | –Minor with cystic fibrosis |
| A | – | –Adult with cystic fibrosis |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children with cystic fibrosis
Key inclusion criteria (3 listed)
- Man /woman older than 18 years (for adult and group)
- Child aged 6 to 18 years (for child group)
- Suffering from cystic fibrosis in stable condition, ie not having presented thrust acute attack of the broncho-pulmonary or hospitalization for treatment of his illness during the previous 2 weeks
Key exclusion criteria (4 listed)
- colonized by Burkholderia cepacia ou Stenotrophomonas maltophilia
- non smoker (control group)
- Without history or respiratory respiratory disease known (control group)
- Antibiotic treatment and / or anti-inflammatory drug (NSAID or corticosteroids) in the 2 weeks prior to the inclusion in the study (control group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 27 Feb 2017.
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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.
Patrice DIOT, PHD principal investigator
Tours Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University Hospital, Tours 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 3 inclusion and 4 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 27 Feb 2017. 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.
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 27 Feb 2017.