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

Cystic Fibrosis Clinical Trial

— RM/NEB-03-10  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01337219
• Other study ID #: RM/NEB-03-10
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 13, 2011
• Last updated: April 15, 2011
• Start date: April 2011

Study information

• Verified date: February 2011
• Source: Erempharma
• Contact: Behrouz Kassaï
• Phone: 04 27857732
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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.

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®

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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 tobramycin, hypersensitivity to aminoside

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Tobramycin

Locations

Country	Name	City	State
France	Centre de Ressource et de Compétence Mucoviscidose Pédiatrique Centre de Référence Mucoviscidose	Lyon

Sponsors (5)

Lead Sponsor	Collaborator
Erempharma	Clininfo S.A., Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME), Hospices Civils de Lyon, University of Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration of tobramycin from 0 to 8h after administration		from 0 to 8h after administration	No
Secondary	sputum of tobramycin concentrations		from 0 to 8 hours after administration	No
Secondary	Safety of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®;		15 days	Yes
Secondary	Time of nebulization of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®		during nebulization	No
Secondary	Satisfaction of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®		after administration of the drug, in average 20 minutes	No