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

PHASE3CompletedINTERVENTIONAL
Enrollment

302

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

June 30, 2013

Study Completion Date

September 18, 2013

Conditions
Pseudomonas Aeruginosa Infection
Interventions
DRUG

Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.

"Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~* 590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~* Administration time is approximately 13 minutes.~* liposomal amikacin for inhalation will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment."

DRUG

Tobramycin inhalation solution using a PARI LC® Plus nebulizer.

"300 mg tobramycin inhalation solution is administered twice a day using a PARI LC® Plus nebulizer.~* Nebulization time is approximately 20 minutes for each administration.~* Tobramycin inhalation solution will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment"

Trial Locations (62)

Unknown

Vienna

Brussels

Ghent

Leuven

Pleven

Plovdiv

Sofia

Varna

Hamilton

Halifax

Vancouver

Copenhagen

Bron

Lille

Montpellier

Nancy

Paris

Pierre-Bénite

Rouen

Berlin

Essen

Hamburg

Hanover

Kiel

München

Athens

Marousi

Budapest

Debrecen

Szeged

Dublin

Ancona

Brescia

Catania

Genova

Milan

Parma

Roma

Verona

Utrecht

Gdansk

Lodz

Lublin

Poznan

Rabka-Zdrój

Rzeszów

Warsaw

New Belgrade

Banská Bystrica

Bratislava

Košice

Barcelona

Madrid

Valencia

Gothenburg

Birmingham

Glasgow

Leeds

Liverpool

London

Nottingham

Penarth

All Listed Sponsors
lead

Insmed Incorporated

INDUSTRY

NCT01315678 - Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections | Biotech Hunter | Biotech Hunter