Completed PHASE3 INTERVENTIONAL 2-arm NCT01315678

Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections

Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

Sponsor: Insmed Incorporated

Conditions Pseudomonas Aeruginosa Infection

Interventions Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer. Tobramycin inhalation solution using a PARI LC® Plus nebulizer.

Updated 9 times since 2017 Last updated: May 28, 2020 Started: Feb 29, 2012 Primary completion: Jun 30, 2013 Completion: Sep 18, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Pseudomonas Aeruginosa Infection, this trial is completed. The trial is conducted by Insmed Incorporated and has accumulated 9 data snapshots since 2012. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jul 2020 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 4 earlier versions

Jul 2019 — Jul 2020 [monthly]

Completed PHASE3
Jun 2018 — Jul 2019 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Feb 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Insmed Incorporated

Data source: Insmed Incorporated

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ancona, Italy , Athens, Greece , Banská Bystrica, Slovakia , Barcelona, Spain , Berlin, Germany , Birmingham, United Kingdom , Bratislava, Slovakia , Brescia, Italy , Bron, France , Brussels, Belgium and 52 more locations