Cystic FibrosisPhase 1COLI-VLMNCT01537614
Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis
A Phase 1 study testing COLIMYCINE inhalation and COLIMYCINE injectable in people with Cystic Fibrosis, run by Poitiers University Hospital at 1 site in France.
Trial summary
Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI colimycin either as an aerosol or after IV injection, the administration being separated by 5 to 10 days intervals Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- COLIMYCINE inhalation and COLIMYCINE injectable
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Feb 2013
- Phase
- Phase 1
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Males and females, adults.
- Suffering from stable cystic fibrosis
- Colonized by P. aeruginosa
- Having given informed consent.
- Able to follow the protocol
- Having a social insurance
Who cannot join
- Renal insufficiency
- Allergy to colistin or polymixins
- Myasthenia
- Recent severe hemoptysis
- Liver cirrhosis and hepatic insufficiency
- Hypoalbuminemia
- Colonization by Burkholderia cepaea or Stenotrophomonas maltophilin
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI colimycin either as an aerosol or after IV injection, the administration being separated by 5 to 10 days intervals
- Conditions
- Cystic Fibrosis
- Being tested
- COLIMYCINE inhalation, COLIMYCINE injectable
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLIMYCINE inhalationDrug
2 MILLION UI
COLIMYCINE injectableDrug
2 MILLIONS UI
| Study group | Role | What they receive |
|---|---|---|
| COLIMYCINE injectable | Experimental | Not described Receives: Drug: COLIMYCINE injectable |
| COLIMYCINE inhalation | Experimental | Not described Receives: Drug: COLIMYCINE inhalation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionFeb 2013
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 Poitiers University HospitalThe 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 1
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537614
- Sponsor's protocol ID
- COLI-VLM
- Acronym
- COLI-VLM
- Status last verified
- Oct 2016
- First submitted
- 17 Feb 2012
- Last updated
- 11 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01537614
- Acronym / sponsor ID
- COLI-VLM / COLI-VLM
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Feb 2013 (actual)
- First posted
- 23 Feb 2012 (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.
Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI colimycin either as an aerosol or after IV injection, the administration being separated by 5 to 10 days intervals
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COLIMYCINE injectable | Experimental | Drug: COLIMYCINE injectable |
| COLIMYCINE inhalation | Experimental | Drug: COLIMYCINE inhalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females, adults.
- Suffering from stable cystic fibrosis
- Colonized by P. aeruginosa
- Having given informed consent.
- Able to follow the protocol
Key exclusion criteria (8 listed)
- Renal insufficiency
- Allergy to colistin or polymixins
- Myasthenia
- Recent severe hemoptysis
- Liver cirrhosis and hepatic insufficiency
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 |
|---|---|---|
| COLIMYCINE inhalation2 MILLION UI | Drug | COLIMYCINE inhalation |
| COLIMYCINE injectable2 MILLIONS UI | Drug | COLIMYCINE injectable |
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 11 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COLIMYCINE inhalation and COLIMYCINE injectable in people with Cystic Fibrosis, run by Poitiers University Hospital 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 6 inclusion and 8 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 11 Oct 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 11 Oct 2016.