A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA

• Conditions: cystic fibrosis and P. aeruginosa chronic infection; MedDRA version: 9.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung; MedDRA version: 9.1Level: LLTClassification code 10057582Term: Lung infection pseudomonal

• Registration Number: EUCTR2006-006215-68-HU
• Lead Sponsor: Chiesi Farmaceutici S.p.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. Patients of either sex aged = 6;
2. Clinical diagnosis of cystic fibrosis defined as:
•patients preferably registered in the National Registry of CF (or other documents depending on country legislation);
•evidence of two or more typical pulmonary clinical features observed in CF e.g persistent colonization/infection with typical CF pathogens, chronic cough and sputum production, persistent chest radiography abnormalities, airway obstruction, nasal polyps and/or digital clubbing.;
3. Positive response in the standard sweat test (sweat chloride concentration = 60 mmol/l) for the standard method or = 80 mmol/L for a microduct technique) documented in the clinical records and/or gene mutation documented in the clinical records;
4. Chronic colonization of P. aeruginosa : presence in a sputum or throat culture of a minimum of 2 positive samples for P. aeruginosa over the previous 12 months and/or presence of more than two precipitating antibodies against P. aeruginosa;
5. Sputum containing P. aeruginosa susceptible to tobramycin (defined as a zone diameter = 16 mm after testing with 10 µg tobramycin disk or as a minimal inhibition concentration based on microdilution testing system) as identified by local laboratory at screening visit;
6. FEV1 = 40% and = 80% of the predicted normal value;
7. Written informed consent obtained by parents/legal representative (according to local regulations) and by the subject (when appropriate).

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Administration of antipseudomonal antibiotic therapy by any route in the previous 4 weeks
2.Evidence of impaired renal function (serum creatinine level = 1.5 mg/dl);
3.Evidence of impaired auditory function (auditory threshold in either ear above 20 dB at frequencies between 250 and 8000Hz);
4.Sputum culture containing Burkholderia cepacia;
5. Patients with end-stage lung disease, candidates for heart-lung transplantation;
6. History of other clinically significant cardiac, renal, neurological, gastrointestinal, hepatic or endocrine disease related to cystic fibrosis, whose sequelae and/or treatment can interfere with the results of the present study;
7. Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e. contraceptive methods other than rod containing a hormone that prevents user from getting pregnant and that will be placed under the skin, syringes that contain a contraceptive hormone, combined birth control pill i.e. such that contains two hormones, some IUDs and sexual abstinence). A pregnancy test in urine is to be carried out in women of a fertile age at screening and at the last clinic visit.
8. Known hypersensitivity to aminoglycosides;
9. Patients with evidence of alcohol or drug abuse, likely to be not compliant with the study protocol or likely to be not compliant with the study treatments;
10. Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit (Visit 1).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified