Cystic FibrosisPhase 1/2RM/NEB-03-10NCT01337219
Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis
A Phase 1/2 study testing Tobramycin in people with Cystic Fibrosis, run by Erempharma at 1 site in France.
Trial summary
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Tobramycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Sep 2011
- Phase
- Phase 1/2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults and children aged 6 years old and more
- Male or female
- Patients with cystic fibrosis (positive sudoral test, Cl > 60 mmol/L)
- Followed in a CRCM (CF care centre)
- FEV1 ≥40%
- Informed consent collected from adults or parents or legal guardians and children.
- Affiliation to the National Health Insurance program (Sécurité sociale).
Who cannot join
- renal insufficiency defined by a creatinine clearance level superior to 2 mg/dl
- recent pneumothorax, emphysema, punction or recent pleural biopsy, recent haemoptysis superior to 60 ml within 30 days prior to randomization
- Acute pulmonary exacerbation pathology, according to conference of consensus (2002), evaluated by :
- Cough increase
- Sputum increase
- Decrease in tolerance to effort
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- Loss of weight, lack of appetite
- Deterioration of respiratory function
- Medical history of intolerance, toxicity or allergy to tobramycin, hypersensitivity to aminoside
Trial locations and contacts
1 site in 1 country.
Behrouz Kassaï contact
Jean-Paul Salin contact
France1 site, 1 recruiting
- Recruiting
Centre de Ressource et de Compétence Mucoviscidose Pédiatrique Centre de Référence Mucoviscidose
Lyon, 69500
Gabriel Bellon, Pr, 04 27 85 59 82 ext. 0033, gabriel.bellon@chu-lyon.fr
Gabriel Bellon, Pr
About this study
Official title: Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis.
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates.
The constant improvement in symptomatic treatments and care strategies allowed CF patients' life expectancy to be increased over the last decades.
Read more
Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.
Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is obtained by inhaled administration of tobramycin and is active against in-vitro resistant Pseudomonas aeruginosa.
Study hypotheses :
Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus® in children and adult patients with CF.
Primary objective :
To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®
- Conditions
- Cystic Fibrosis
- Being tested
- Tobramycin
- Keywords
- cystic fibrosis, bioequivalence, pharmacokinetic, sputum, plasma
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobramycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Other | experimental treatment (Nebcinal/Aeroneb Idehaler pocket) - 6day-wash out period - standard treatment (Tobi/Pari LC Plus) Receives: Drug: Tobramycin |
| Arm B | Other | standard treatment (Tobi/Pari LC Plus) - 6day-wash out period - experimental treatment (Nebcinal/Aeroneb Idehaler) Receives: Drug: Tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of tobramycin from 0 to 8h after administration
Measured: from 0 to 8h after administration
Secondary outcomes (4)
sputum of tobramycin concentrations
Measured: from 0 to 8 hours after administration
Safety of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®;
Measured: 15 days
Time of nebulization of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®
Measured: during nebulization
Satisfaction of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®
Measured: after administration of the drug, in average 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2011 (estimated)
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erempharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Lyon, Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME), Clininfo S.A., Hospices Civils de Lyon
- Investigators
- Gabriel Bellon, Principal investigator, Centre de Resources et de competences pour la mucovisidoseIsabelle Durieu, Pr, Principal investigator, Centre de Resources et de competences pour la mucovisidose Hôpital Lyon Sudbehrouz Kassai, Dr, Study chair, University of Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337219
- Sponsor's protocol ID
- RM/NEB-03-10
- Acronym
- RM/NEB-03-10
- Status last verified
- Feb 2011
- First submitted
- 13 Apr 2011
- Last updated
- 18 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT01337219
- Acronym / sponsor ID
- RM/NEB-03-10 / RM/NEB-03-10
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, bioequivalence, pharmacokinetic, sputum, plasma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- ErempharmaIndustry (pharma, biotech, devices)
- Collaborators
- University of Lyon, Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME), Clininfo S.A., Hospices Civils de Lyon
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (estimated)
- First posted
- 18 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.
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates.
The constant improvement in symptomatic treatments and care strategies allowed CF patients' life expectancy to be increased over the last decades.
Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.
Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is obtained by inhaled administration of tobramycin and is active against in-vitro resistant Pseudomonas aeruginosa.
Study hypotheses :
Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus® in children and adult patients with CF.
Primary objective :
To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | Drug: Tobramycinexperimental treatment (Nebcinal/Aeroneb Idehaler pocket) - 6day-wash out period - standard treatment (Tobi/Pari LC Plus) |
| Arm B | Other | Drug: Tobramycinstandard treatment (Tobi/Pari LC Plus) - 6day-wash out period - experimental treatment (Nebcinal/Aeroneb Idehaler) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Adults and children aged 6 years old and more
- Male or female
- Patients with cystic fibrosis (positive sudoral test, Cl > 60 mmol/L)
- Followed in a CRCM (CF care centre)
- FEV1 ≥40%
Key exclusion criteria (9 listed)
- renal insufficiency defined by a creatinine clearance level superior to 2 mg/dl
- recent pneumothorax, emphysema, punction or recent pleural biopsy, recent haemoptysis superior to 60 ml within 30 days prior to randomization
- Acute pulmonary exacerbation pathology, according to conference of consensus (2002), evaluated by :
- Cough increase
- Sputum increase
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 |
|---|---|---|
| Tobramycin | Drug | Arm A, Arm B |
Primary outcome
Plasma concentration of tobramycin from 0 to 8h after administration
Time frame: from 0 to 8h after administration
4 secondary outcomes
sputum of tobramycin concentrations
Time frame: from 0 to 8 hours after administration
Safety of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®;
Time frame: 15 days
Time of nebulization of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®
Time frame: during nebulization
Satisfaction of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®
Time frame: after administration of the drug, in average 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2011.
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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.
Behrouz Kassaï contact
Jean-Paul Salin contact
Gabriel Bellon principal investigator
Centre de Resources et de competences pour la mucovisidose
Isabelle Durieu, Pr principal investigator
Centre de Resources et de competences pour la mucovisidose Hôpital Lyon Sud
behrouz Kassai, Dr study chair
University of Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tobramycin in people with Cystic Fibrosis, run by Erempharma 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Apr 2011. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Behrouz Kassaï (04 27857732 ext. 0033), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of tobramycin from 0 to 8h after administration (time frame: from 0 to 8h after administration). 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 18 Apr 2011.