CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
280 mg Arikayce™ +3 moredrug
Likely dose
280 mg Arikayce™from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00775138
NCT00775138Phase 2Completed
CompareCT.gov

A Placebo Controlled, Randomized, Parallel Cohort, Safety And Tolerability Study Of 2 Dose Levels Of Liposomal Amikacin For Inhalation (Arikayce™) In Patients With Bronchiectasis Complicated By Chronic Infection Due To Pseudomonas Aeruginosa.

Insmed Incorporated·interventional·Posted Oct 17, 2008·Updated Jul 10, 2019

In Brief

A Phase 2 clinical trial evaluating 280 mg Arikayce™, Matching Placebo for Cohort 1, and 2 other interventions for Bronchiectasis. Completed, enrolled 64 participants across 18 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBronchiectasis
CountriesBulgaria, Greece, Hungary, India, Poland, Serbia, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 17, 2008
Enrollment StartJun 24, 2008
Primary CompletionMay 11, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.7 years ago

Interventions

280 mg Arikayce™drug

Study subjects will receive Arikace™ 280 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.

Matching Placebo for Cohort 1drug

Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.

560 mg Arikayce™drug

Study subjects will receive Arikace™ 560 mg on Days 1 through Day 28. Drug is administered once a day via a nebulizer.

Matching Placebo for Cohort 2drug

Study subjects will receive placebo on Days 1 through Day 28. Drug is administered once a day via a nebulizer.