A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®

Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateFebruary 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: April 20, 2009)
Change from baseline of FEV₁, expressed as percentage of predicted normal at the end of the treatment phase (week 4). [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00885365 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: April 20, 2009)
  • Other pulmonary function parameters, such as FEV₁ % predicted measured at Visit 3 and Visit 5, FEV₁ expressed as litres, FVC as litres and % predicted, FEF25-75% expressed as litres and % predicted measured at Visit 3, Visit 4 and Visit 5. [ Time Frame: Week 2, Week 4, Week 8 ] [ Designated as safety issue: No ]
  • Audiometric tests [ Time Frame: Screening, Week 4, Week 8 ] [ Designated as safety issue: Yes ]
  • Hematology and blood chemistry [ Time Frame: Screening, Week 4 ] [ Designated as safety issue: Yes ]
  • Vital Signs, Physical Examination [ Time Frame: Screening, Day 0, Week 2, Week 4, Week 8 ] [ Designated as safety issue: Yes ]
  • Categorical results of microbiological tests referred to P. aeruginosa (PA) (negative or positive culture, superinfection, re-infection); sputum culture & MIC50 & MIC90 of isolated PA strains; PA bacterial load (CFUs) performed at visit 4 [ Time Frame: Screening, Week 4, Week 8 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
Official Title  ICMJEA Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa
Brief Summary

The purpose of this study is to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in primary efficacy variable, forced expiratory volume in one second (FEV₁) percent of predicted normal, and to compare their safety in patients with cystic fibrosis and chronic infection of the lungs with P. aeruginosa.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJECystic Fibrosis
Intervention  ICMJE
  • Drug: tobramycin
    300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen
    Other Name: Tobrineb®/Actitob®/Bramitob®
  • Drug: tobramycin
    300mg/5 ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen
    Other Name: TOBI®
Study Arms / Comparison Groups
  • 1: Active Comparator
    Tobrineb®/Actitob®/Bramitob®, tobramycin 300mg/4ml solution
    Intervention: Drug: tobramycin
  • 2: Active Comparator
    TOBI® Nebuliser tobramycin 300mg/5 ml solution
    Intervention: Drug: tobramycin
Publications *

Recruitment Information

Estimated Enrollment  ICMJE320
Estimated Completion DateFebruary 2010
Estimated Primary Completion DateFebruary 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
  • 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 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 (Visit 1).
Ages6 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Guido Varoli+39 0521-279718g.varoli@chiesigroup.com
Contact: Helen Cicirello, MD+301-424-2661hcicirello@chiesiusa.com
Location Countries  ICMJECzech Republic,   Germany,   Hungary,   Poland,   Russian Federation,   Spain,   Ukraine

Administrative Information

Responsible PartyDr. Henryk Mazurek, Klinika Pneumonologii i Mukowiscydozy, Instytutu Gruzlicy i Chorob Pluc w Rabce Zdroj
Study ID Numbers  ICMJECMA-0631-PR-0010
Study Sponsor  ICMJEChiesi Farmaceutici S.p.A.
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Henryk Mazurek, DoctorKlinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
Information Provided ByChiesi Farmaceutici S.p.A.