Cystic FibrosisNCT01288170
Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®
A study testing Nebcinal Tobi and Tobi Nebcinal in people with Cystic Fibrosis, run by Erempharma at 2 sites 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 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Nebcinal Tobi and Tobi Nebcinal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2010to Jul 2010
- 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 6 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, Loss of weight, lack of appetite, Deterioration of respiratory function,
- Medical history of intolerance, toxicity or allergy to tobramycine, hypersensitivity to aminoside
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre de ressources et de compétences pour la mucovisidose, enfants
Bron, 69500
Gabriel Bellon, Professor
- Not yet recruiting
Centre de ressources et de compétences pour la mucovisidose, adultes
Pierre-Bénite, 69495
Isabelle Durieu, Professor
About this study
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
- Nebcinal Tobi, Tobi Nebcinal
- 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.
Nebcinal TobiDrug
Tobi NebcinalDrug
| Study group | Role | What they receive |
|---|---|---|
| Nebcinal Tobi | Other | crossover design Receives: Drug: Nebcinal Tobi |
| Tobi Nebcinal | Other | crossover design Receives: Drug: Tobi Nebcinal |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma Area under the curve from 0 to 8 hours of tobramycine after administration of the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startFeb 2010
- Primary completionJul 2010 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erempharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospices Civils de Lyon, University of Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288170
- Sponsor's protocol ID
- RM/NEB-02/09
- Status last verified
- Feb 2011
- First submitted
- 1 Feb 2011
- Last updated
- 2 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 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®
- ClinicalTrials.gov ID
- NCT01288170
- Acronym / sponsor ID
- RM/NEB-02/09
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, bioequivalence, pharmacokinetic, sputum, plasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- ErempharmaIndustry (pharma, biotech, devices)
- Collaborators
- Hospices Civils de Lyon, University of Lyon
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (estimated)
- First posted
- 2 Feb 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 |
|---|---|---|
| Nebcinal Tobi | Other | Drug: Nebcinal Tobicrossover design |
| Tobi Nebcinal | Other | Drug: Tobi Nebcinalcrossover design |
Who may qualify
- Ages
- 6 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 (5 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, Decrease in tolerance to effort, Loss of weight, lack of appetite, Deterioration of respiratory function,
- Medical history of intolerance, toxicity or allergy to tobramycine, hypersensitivity to aminoside
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 |
|---|---|---|
| Nebcinal Tobi | Drug | Nebcinal Tobi |
| Tobi Nebcinal | Drug | Tobi Nebcinal |
Primary outcome
plasma Area under the curve from 0 to 8 hours of tobramycine after administration of the drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebcinal Tobi and Tobi Nebcinal in people with Cystic Fibrosis, run by Erempharma at 2 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 7 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: status not confirmed, as of the sponsor's last update on 2 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Behrouz Kassaï (0427857732 ext. 0033, behrouz.kassai-koupai@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma Area under the curve from 0 to 8 hours of tobramycine after administration of the drug. 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 2 Feb 2011.