Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

October 5, 2012

Primary Completion Date

July 16, 2015

Study Completion Date

July 16, 2015

Conditions
Cystic Fibrosis
Interventions
DRUG

Liposomal amikacin for inhalation

"* 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 in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment."

Trial Locations (50)

Unknown

Vienna

Antwerp

Brussels

Ghent

Leuven

Pleven

Plovdiv

Sofia

Varna

Halifax

Hamilton

Vancouver

Copenhagen

Lille

Paris

Berlin

Essen

Hamburg

Hanover

München

Athens

Marousi

Budapest

Debrecen

Szeged

Dublin

Brescia

Catania

Parma

Roma

Verona

Utrecht

Gdansk

Lodz

Lublin

Poznan

Rabka-Zdrój

Rzeszów

Warsaw

Belgrade

Banská Bystrica

Bratislava

Košice

Barcelona

Madrid

Valencia

Leeds

London

Nottingham

Penarth

All Listed Sponsors
lead

Insmed Incorporated

INDUSTRY

NCT01316276 - Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection | Biotech Hunter | Biotech Hunter