A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
Study Identifier:
CMA-0631-PR-0010 Core
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Cystic Fibrosis
Study Drug
- Drug: tobramycin / Bramitob
- Drug: tobramycin / TOBI
Date
Apr 2009 - Apr 2010
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 6+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Patients of either sex aged ≥ 6;
- Clinical diagnosis of cystic fibrosis defined as: (1)Patients preferably registered in the National Registry of CF (or other documents depending on country legislation); (2) 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;
- 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;
- 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;
- 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;
- Forced expiratory volume in 1 sec (FEV₁) ≥ 40% and ≤ 80% of the predicted normal value;
- Written informed consent obtained by parents/legal representative according to local regulations) and by the patient (when appropriate).
Exclusion Criteria
- Administration of antipseudomonal antibiotic therapy by any route in the previous 4 weeks;
- Evidence of impaired renal function (serum creatinine level ≥ 1.5 mg/dl);
- Evidence of impaired auditory function (auditory threshold in either ear above 20 dB at frequencies between 250 and 8000Hz);
- Sputum culture containing Burkholderia cepacia;
- Patients with end-stage lung disease, candidates for heart-lung transplantation;
- 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;
- 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 intrauterine devices (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;
- Known hypersensitivity to aminoglycosides;
- 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;
- Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit.
Healthy Volunteers
No
Protocol Summary
The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.
Study Locations
Location
Status
Location
Centrum pro cystickou fibrosu, Pediatricka klinika UK 2.LF, Fakultní nemocnice v Motole
Prague, Czech Republic, 150 06
Status
N/A
Location
CHR Clemenceau
Caen, France, 14 033
Status
N/A
Location
Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires
Montpellier, France, 34 295
Status
N/A
Location
Hopital Necker
Paris, France, 75 015
Status
N/A
Location
Pädiatrische Pneumologie und Allergologie, Mukovizidose-Zentrum, Zentrum für Kinderheilkunde und Jugendmedizin
GieBen, Germany, 35385
Status
N/A
Location
HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin
Krefeld, Germany, 47805
Status
N/A
Go to page