4 results
The primary objectives of the trial are to investigate the effect of the use of inhaled colistimethate sodium, administered twice daily via the I-Neb for 12 months, compared to placebo in subjects with non*cystic fibrosis bronchiectasis (NCFB)…
To investigate the clinical pharmacokinetics of tobramycin and/or colistin after nasal administration. With this pharmacokinetic parameters the safety of this treatment can be investigated.
Objective: Primary Objective 1: Demonstrate efficient and stable control of essential BCI functions (initiate BCI, call caregiver, and menu selections). Primary Objective 2: Demonstrate efficient and stable operation of a keyword-based speech BCI.
The scientific rationale for the study is summarized above and further detailed in Section 3 and the Investigator Brochure (IB). This Phase 2 randomized, double-blind clinical trial is designed to assess the safety and efficacy of BMS-986165 in…