INDICATION AND IMPORTANT SAFETY INFORMATION
TOBI® Podhaler® (Tobramycin Inhalation Powder) 28 mg per capsule is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.  ...More

EVOLVE & EDIT Clinical Trials

Improvement in Lung Function vs
Placebo

EVOLVE Study

TOBI® Podhaler® improved lung function vs placebo1

Relative change in forced expiratory volume in 1 second (FEV1)% predicted at the end of Cycle 1 dosing (P=0.002)1,*

Primary endpoint in EVOLVE (Study 2)1

  • Mean absolute changes in FEV1 predicted: TOBI Podhaler, +6.38%; placebo, -0.52%; difference of 6.90% (95% CI: 2.40, 11.40)1

EVOLVE, Evaluate tobramycin inhaled dry powder efficacy versus placebo in cystic fibrosis patients.

*Each cycle consisted of 28 days on treatment followed by 28 days off treatment.1

Study design: EVOLVE was a 24-week, randomized, double-blind (during Cycle 1) trial in patients aged 6 to 21 years with cystic fibrosis (CF), Pseudomonas aeruginosa (Pa), and FEV1 ≥25% and ≤80% predicted at screening. The first cycle was double-blind and placebo-controlled with eligible patients randomized 1:1 to TOBI Podhaler (four 28-mg capsules twice daily) or placebo. For Cycles 2 and 3, patients who were initially randomized to placebo received TOBI Podhaler. Of the 79 patients included in the prespecified interim analysis, 18 were excluded due to a failure to meet spirometry quality review criteria, which resulted in a total of 61 patients included in the primary analysis.1,2

Patients who switched from placebo to TOBI Podhaler after Cycle 1 demonstrated improvements in lung function1

Relative change in FEV1% predicted from baseline (Cycles 1-3)1

Error bars represent mean relative change (95% CI).1

  • Improvements in lung function were achieved during the subsequent cycles of treatment with TOBI Podhaler, although the magnitude of improvement was reduced1

Please see Indication and Important Safety Information.

Patients taking TOBI Podhaler experienced fewer respiratory-related hospitalizations and needed fewer intravenous (IV) antipseudomonal antibiotics

64% reduction in the percentage of patients with respiratory-related hospitalizations

Secondary endpoint in EVOLVE (Study 2, Cycle 1)1,2

  • 4.4% in the TOBI Podhaler treatment group vs 12.2% in the placebo group1
15%
reduction in the percentage of patients needing IV antipseudomonal antibiotics

Secondary endpoint in EVOLVE (Study 2, Cycle 1)1,2

  • 8.7% in the TOBI Podhaler treatment group vs 10.2% in the placebo group1

EDIT Study

Lung function in patients treated with TOBI Podhaler vs placebo was also evaluated in a separate 8-week study1

Relative change in FEV1% predicted at end of Cycle 1 dosing (P=0.167)1

Primary endpoint in EDIT (Study 3)1

  • Results not statistically significant1
  • Mean absolute change in FEV1% predicted was 4.86% for TOBI Podhaler and 0.48% for placebo, with a difference of 4.38% (95% CI: -0.17, 8.94)1

EDIT Study Design

  • EDIT was an 8-week, randomized, double-blind, placebo-controlled study in patients aged 6 to 21 years with CF, Pa, and FEV1 ≥25% and ≤80% predicted at screening1,*
  • Patients with any use of inhaled antipseudomonal antibiotics within 4 months prior to screening were excluded1
  • Eligible patients were randomized 1:1 to receive TOBI Podhaler (4 times 28-mg capsules twice daily; n=32) or placebo (n=30) for one cycle (28 days on treatment and 28 days off treatment)1
  • The EDIT Study was underpowered due to an inability to recruit the prespecified number of TOBI-naïve patients into each arm3

EDIT, Establish tobramycin dry powder efficacy in cystic fibrosis.

*Decreased susceptibility of Pa to tobramycin has been seen with use of TOBI Podhaler. The relationship between in vitro susceptibility test results and clinical outcome with TOBI Podhaler therapy is not clear. Occurrence of decreased susceptibility on treatment should be monitored, and treatment with an alternative therapy should be considered if clinical worsening is observed.1

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Inform your patients about what to expect while taking TOBI® Podhaler®

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ADMINISTRATION INFORMATION

Administration information and helpful tips for patients taking TOBI® Podhaler®

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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

TOBI® Podhaler® (Tobramycin Inhalation Powder) 28 mg per capsule is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in
1 second
(FEV1) <25% or >80% predicted, or patients colonized with Burkholderia cepacia.