At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Crossover, Interventional Phase IV Study to Compare the Ease of Use of TIP With Nebulized TIS and Nebulized COLI for the Treatment of Pulmonary Pseudomonas Aeruginosa (P.a) in Patients With Cystic Fibrosis
In Brief
A Phase 4 clinical trial evaluating Tobramycin Inhalation Powder, Tobramycin inhalation solution, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 60 participants across 21 sites in 5 countries.
Detailed Summary
The purpose of this interventional Phase IV study was to explore the ease of use of TIP and prevalence of microbial contamination of the T-326 Inhaler compared with TIS and colistimethate administered via nebuliser for the treatment of Cystic Fibrosis (CF) patients chronically infected with P. aeruginosa. It was anticipated that the data from this study would provide clinicians with further guidance on the relative differences between the speed and ease of use of these treatments as well as useful information on the prevalence of microbial contamination of the inhalation devices in "real world" use.
Study Details
Timeline
Interventions
Tobramycin Inhalation Powder was administered via TOBI® Podhaler (T-326 inhaler).
Tobramycin inhalation solution was administered via nebuliser
Colistimethate was administered via nebuliser.