drugset / Trial / NCT01844778

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

NCT01844778

Phase 4 Completed 60 enrolled Novartis Pharmaceuticals
Non-randomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2013-08
Primary completion
2015-10
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Colistimethate Unknown 1e+06 iu Inhaled
Comparator Colistimethate Unknown 2e+06 iu Inhaled
Comparator Tobramycin Small molecule 112 mg Inhaled
Comparator Tobramycin Small molecule 300 mg Inhaled

Indications