Tobramycin Inhalation Powder

DRUG8 trials

Sponsors

Novartis, Novartis Pharmaceuticals

Conditions

Cystic FibrosisPseudomonas AeruginosaPulmonary Infectionsnon-cystic fibrosis bronchiectasis

Phase 2

A randomized, blinded, parallel group, multi-center dose- finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection

Novartisnon-cystic fibrosis bronchiectasis

Target: 10Updated: 2024-02-28

Phase 3

Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects

TerminatedNCT00125346

NovartisCystic Fibrosis

Start: 2005-09-30End: 2007-02-28Updated: 2011-10-12

Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis

CompletedNCT00388505

Novartis PharmaceuticalsCystic Fibrosis

Start: 2006-02-28End: 2009-03-31Updated: 2012-07-24

A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo

CompletedNCT00918957

Novartis PharmaceuticalsCystic Fibrosis

Start: 2009-06-30End: 2011-05-31Updated: 2012-10-03

Open Label Extension to Bridging Study CTBM100C2303

CompletedNCT00982930

Novartis PharmaceuticalsCystic Fibrosis, Pseudomonas Aeruginosa

Start: 2009-08-12End: 2011-10-06Updated: 2021-06-02

Second Open Label Extension to Bridging Study CTBM100C2303

CompletedNCT01069705

Novartis PharmaceuticalsPseudomonas Aeruginosa, Pulmonary Infections

Start: 2010-02-12End: 2012-03-19Updated: 2021-06-02

Phase 4

Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)

CompletedNCT01844778

Novartis PharmaceuticalsCystic Fibrosis

Start: 2013-08-31End: 2015-10-31Updated: 2016-07-27

Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles

TerminatedNCT02015663

Novartis PharmaceuticalsCystic Fibrosis

Start: 2014-01-31End: 2014-12-31Updated: 2017-03-29

Related Papers

Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial.

2013-06-0534 citations