INTENDED FOR UK & IRELAND HEALTHCARE PROFESSIONALS

INTENDED FOR UK & IRELAND HEALTHCARE PROFESSIONALS

PRESCRIBING INFORMATION

Overview of Bramitob® (tobramycin) key studies

Select a key study below to learn more about its design, endpoints and results.

  • CT01, Lenoir G, et al ¹

  • CT02, Chuchalin A, et al ²

  • Mazurek H, et al ³

Study aim: Investigate the efficacy and safety of a highly concentrated (300mg/4ml) tobramycin solution for inhalation (Bramitob) in patients with cystic fibrosis and Pseudomonas aeruginosa infection

Study design: Phase III, prospective, randomised 2:1 (tobramycin:placebo), double-blind, placebo-controlled, parallel-group, multinational clinical trial

Age: ≥6 years

Primary endpoint: Change in FEV1 % predicted at week 4

Secondary endpoints: FVC and FEF25–75 % predicted, P. aeruginosa susceptibility, minimum concentration required to inhibit 90% of strains (MIC90), safety

FEV1% PREDICTED VS PLACEBO AT WEEKS 2 AND 41

STUDY OVERVIEW

AE, adverse event; FEV1, forced expiratory volume in 1 second; PBO, placebo

Study aim: Assess efficacy and tolerability of tobramycin highly concentrated solution for inhalation (300mg/4ml) (Bramitob), when added to other anti-pseudomonal therapies in cystic fibrosis patients with chronic Pseudomonas aeruginosa infection

Study design: Phase III, double-blind, randomised 2:1, placebo-controlled, multi-centre, 24-week study period with three 4-week treatment periods and three 4-week off periods in an alternating cycle

Age: ≥6 years

Primary endpoint: Change in FEV1 % predicted at week 20

Secondary endpoints: FVC and FEF25–75 % predicted, P. aeruginosa susceptibility, minimum concentration required to inhibit 90% of strains (MIC90), rates of P. aeruginosa-negative culture, P. aeruginosa persistence and superinfection, pulmonary exacerbations, need for hospitalisation and parenteral antipseudomonal antibiotics, loss of school/working days due to the disease, and nutritional status (bodyweight and body mass index)

MEAN FEV1% PREDICTED VS PLACEBO AT EACH TIMEPOINT2

Change from baseline in mean forced expiratory volume in 1 second (FEV1) percent predicted. * p < 0.01, ** p < 0.001 vs placebo; † p < 0.001 vs baseline.

FVC AND FEF25-75% - CHANGE FROM BASELINE TO STUDY ENDPOINT2

MICROBIOLOGIC ASSESSMENT OUTCOMESa2

a. Statistical analysis performed between groups

NA – not available/assessed

ADDITIONAL SECONDARY ENDPOINTS WITHIN THE INTENTION-TO-TREAT POPULATION2

STUDY OVERVIEW

AE, adverse event; BID, twice daily; CI, confidence interval; FEF, forced expiratory flow; FEF25-75%, forced expiratory flow at 25-75%, FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; PBO, placebo; SAE, serious adverse event

Study aim: Investigate the efficacy and safety of Bramitob compared to Tobramycin 300mg/5ml (Mylan) in patients with cystic fibrosis and Pseudomonas aeruginosa infection

Study design: Phase III, prospective, randomised, 8 week open-label trial of Bramitob vs Tobramycin 300mg/5ml (Mylan) (non-inferiority core study), followed by a 6 cycle, 48 week single-arm extension study

Age: ≥6 years

Primary endpoint: Absolute change in FEV1 % predicted from baseline to week 4 (non-inferiority core study)

Secondary endpoints: N/A

ABSOLUTE CHANGE IN FEV1% PREDICTED DURING THE CORE AND EXTENSION PHASES FROM BASELINE

*Patients initially treated in TNS4 n=100, Patients initially treated in TNS5 n=109

No assessments at weeks 20, 36 and 44

TNS4, Bramitob 300mg/4ml; inhaled
TNS5, Tobramycin 300mg/5ml (Mylan); inhaled

Bramitob was non-inferior to TNS5 at week 4, with a difference between groups of -0.5% (95% CI: -2.6; 1.6)

P.AERUGINOSA BACTERIAL LOAD (LOG10 COLONY-FORMING-UNITS [CFU] PER GRAM) IN SPUTUM BY WEEK; CHANGE FROM BASELINE

*Patients initially treated in TNS4 n=100, Patients initially treated in TNS5 n=109

No assessments at weeks 20, 36 and 44

TNS4, Bramitob 300mg/4ml; inhaled
TNS5, Tobramycin 300mg/5ml (Mylan); inhaled

STUDY OVERVIEW

AE, adverse event; FEV1, forced expiratory volume in 1 second; PBO, placebo


  1. Lenoir G, et al. Pediatr Drugs. 2007;9 Suppl. 1:11-20.
  2. Chuchalin A, et al. Pediatr Drugs. 2007; 9 Suppl. 1:21-31.
  3. Mazurek H, et al. Pediatr Pulmonol. 2014; 49:1076-89.