drugset / Trial / NCT00775138

Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.

NCT00775138

Phase 2 Completed 64 enrolled Insmed Incorporated
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a study to determine the safety and tolerability of 28 days of daily dosing of two doses (280 mg and 560 mg) of Arikayce™ versus placebo in patients who have bronchiectasis and chronic infection due to Pseudomonas infection.

Timeline

Start
2008-06-24
Primary completion
2009-05-11
Completion
2009-05-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Amikacin Small molecule 280 mg Inhaled
Subject Amikacin Small molecule 560 mg Inhaled

Indications