TOBI Podhaler (tobramycin inhalation powder) / Viatris - LARVOL DELTA

PETIS: Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution (clinicaltrials.gov) - P=N/A | N=5 | Terminated | Sponsor: Rush University Medical Center | The student graduated prior to the subjects completing all research related activities. As a result, the study was closed prematurely.

Trial termination • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Dietary Replacement Effect of Fish Meal by Tuna By-Product Meal on Growth and Feed Availability of Red Sea Bream (Pagrus major). (PubMed, Animals (Basel)) - "FM substitution in the Con diet was made in increments of 20 percentage points (20, 40, 60, 80, and 100%), named as the TBM20, TBM40, TBM60, TBM80, and TBM100 diets, respectively...The greatest economic profit index was achieved in the TBM40 diet. In conclusion, the replacement of 40% FM with TBM in red sea bream diet appears to be the most recommendable approach without producing retarded growth and feed availability, but maximizing EPI to farmers."

Journal • Hematological Disorders

Vantobra®, a new formulation of nebulised tobramycin: early real-world experiences at our large regional UK adult cystic fibrosis centre (ECFS 2023) - "83% (15) had tried and discontinued (due to adverse events (AEs) or adherence or both) at least 1 other formulation of inhaled tobramycin (TOBI®Podhaler® (14), Bramitob® (6) or TOBI® (6)). Our early real-world experiences with Vantobra® have shown that it is well tolerated and has the potential to improve adherence to treatment in pwCF.Reference: Sands. D et al (2014)Journal of Cystic Fibrosis.13(6)653-660."

Clinical • Real-world • Real-world evidence • Cough • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Long-term tolerability and use of tobipodhaler in people with cystic fibrosis (ECFS 2022) - "58.5% of pwCF who started TIP at RBH continue to use it as part of their anti-pseudomonal maintenance therapy. The primary reason for stopping TIP is documented as adverse side effects. In this data it was primarily chest tightness rather than cough or dysphonia as per previous TIP studies."

Cough • Cystic Fibrosis • Dysphonia • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

The Use of Tobramycin for Pseudomonas aeruginosa: A Review. (PubMed, Expert Rev Respir Med) - "Tobramycin has in vitro activity against Gram-negative bacteria, including P. aeruginosa, and TOBI Podhaler is indicated for the management of individuals with cystic fibrosis with P. aeruginosa infection. Providing a less burdensome alternative to delivering inhaled antibiotics that is more portable with a significantly shorter administration time may help improve adherence, and therefore improve outcomes. Continued development of new antibiotics to add to current regimens for eradication and control of airway microbiology, combined with more efficient delivery systems such as tobramycin inhaled powder, will help evolve the treatment of patients with CF."

Journal • Review • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Observational Study in Cystic Fibrosis Patients Using TOBI® PODHALER® or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs (clinicaltrials.gov) - P=N/A | N=409 | Completed | Sponsor: Mylan Inc. | Active, not recruiting ➔ Completed | N=260 ➔ 409 | Trial completion date: Jul 2023 ➔ Dec 2021 | Trial primary completion date: Jul 2023 ➔ Dec 2021

Enrollment change • FDA event • Trial completion • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

"Apparently you can get an inhaler...TOBI Podhaler.." (@dodgylungsrunna)

PETIS: Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution (clinicaltrials.gov) - P=N/A; N=5; Completed; Sponsor: Rush University Medical Center; N=15 ➔ 5

Clinical • Enrollment change • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] Effect of treatment with the TOBI Podhaler® on the airway microbiota in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study (WBC 2020) - No abstract available

Clinical • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases

[VIRTUAL] Efficacy of inhaled dry powder tobramycin (TOBI Podhaler) in P. aeruginosa infected patients with bronchiectasis - iBEST study (ERS 2020) - "Conclusion Continuous- and cyclical-TIP with all 3 doses were effective in reducing the Pa load in BE patients with chronic Pa infection. Also, trends in reduction of exacerbation episodes and use of anti-pseudomonal antibiotics were noted with TIP as compared to PBO."

Clinical • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases

Efficacy and safety of TOBI Podhaler® in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study. (PubMed, Eur Respir J) - "Continuous- and cyclical-TIP regimens with all three doses were safe and effective in reducing the Pa sputum density in patients with BE and chronic Pa infection."

Clinical • Journal • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases