drugset / Trial / NCT01844778
Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |