Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa

PHASE3CompletedINTERVENTIONAL
Enrollment

274

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

May 31, 2010

Study Completion Date

November 30, 2010

Conditions
Cystic Fibrosis
Interventions
DRUG

Aztreonam for Inhalation Solution (AZLI)

Aztreonam for inhalation solution (75 mg) was administered 3 times a day (TID) for 28 days for each treatment cycle via the PARI eFlow electronic nebulizer.

DRUG

Tobramycin Inhalation Solution (TIS)

Tobramycin inhalation solution (300 mg) was administered 2 times a day (BID) for 28 days for each treatment cycle via the PARI LC Plus nebulizer with compressor or via another nebulizer compatible with country-specified labeling.

Trial Locations (92)

4

Dublin

9

Dublin

24

Dublin

1070

Brussels

1090

Brussels

2650

Antwerp

3000

Leuven

6229

Maastricht

9000

Ghent

11040

New Hyde Park

12208

Albany

13125

Berlin

14000

Caen

14100

Lisieux

17033

Hershey

19102

Philadelphia

19104

Philadelphia

19803

Wilmington

20122

Milan

22763

Hamburg

23298

Richmond

28009

Madrid

28034

Madrid

28041

Madrid

28046

Madrid

29011

Málaga

29425

Charleston

32801

Orlando

33076

Bordeaux

33604

Pessac

33606

Tampa

34295

Montpellier

35033

Rennes

35392

Giessen

37126

Verona

39120

Magdeburg

43100

Parma

43606

Toledo

44791

Bochum

45122

Essen

45229

Cincinnati

45239

Essen

45404

Dayton

55101

Mainz

59037

Lille

60025

Glenview

60123

Ancona

60637

Chicago

60714

Niles

65212

Columbia

73112

Oklahoma City

75743

Paris

77030

Houston

78212

San Antonio

80045

Aurora

80054

Amiens

80131

Napoli

80206

Denver

80336

München

84132

Salt Lake City

85006

Phoenix

85724

Tuscon

89107

Las Vegas

90134

Palermo

92868

Orange

94000

Créteil

95123

Catania

99508

Anchorage

123353

Berlin

02115

Boston

A-6020

Innsbruck

A-5020

Salzburg

DK-2100

Copenhagen

06202

Nice

04103

Leipzig

Unknown

Dublin

Galway

00161

Rome

00165

Rome

2504 LN

The Hague

1649-035

Lisbon

4200 319

Porto

CH - 8032

Zurich

CH - 8091

Zurich

S10 2TH

Sheffield

BT9 7AB

Belfast

CB23 3RE

Cambridge

CF64-2XX

Cardiff

LS9 7TF

Leeds

L14 3PE

Liverpool

SW3 6NP

London

SO16 6YD

Southampton

Sponsors
All Listed Sponsors
collaborator

Chiltern International Inc.

INDUSTRY

collaborator

ClinPhone, Inc.

INDUSTRY

collaborator

Covance

INDUSTRY

lead

Gilead Sciences

INDUSTRY