Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis

PHASE2CompletedINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Cystic Fibrosis
Interventions
DRUG

Ciprofloxacin (Cipro Inhale, BAYQ3939)

32.5 mg ciprofloxacin DPI corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days

DRUG

Placebo

50 mg matching placebo powder formulation twice a day for 28 days

DRUG

Ciprofloxacin (Cipro Inhale, BAYQ3939)

48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)

DRUG

Placebo

75 mg matching placebo powder formulation twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2)

Trial Locations (86)

2100

Copenhagen

3052

Parkville

3168

Clayton

4029

Brisbane

4032

Chermside

4101

South Brisbane

5000

Adelaide

6009

Nedlands

10595

Valhalla

11040

New Hyde Park

12200

Berlin

12208

Albany

19134

Philadelphia

22908

Charlottesville

27710

Durham

29425

Charleston

32207

Jacksonville

32801

Orlando

32803

Orlando

32806

Orlando

33136

Miami

37916

Knoxville

39216

Jackson

40207

Louisville

43606

Toledo

46202

Indianapolis

48109

Ann Arbor

49007

Kalamazoo

53792

Madison

60025

Glenview

60153

Maywood

60590

Frankfurt am Main

60612

Chicago

60614

Chicago

72205

Little Rock

73104

Oklahoma City

73112

Oklahoma City

74145

Tulsa

78212

San Antonio

78723

Austin

80045

Aurora

80336

München

84132

Salt Lake City

85016

Phoenix

85724

Tucson

89107

Las Vegas

90027

Los Angeles

90033

Los Angeles

90048

Los Angeles

92868

Orange

93003

Ventura

94143

San Francisco

98105

Seattle

92123-4282

San Diego

06102

Hartford

06520

New Haven

30912-4005

Augusta

52242-1089

Iowa City

40536-0284

Lexington

02111

Boston

02115

Boston

07039

Livingston

07740

Long Branch

07962

Morristown

08876

Somerville

44308-1062

Akron

45229-3039

Cincinnati

17033-0850

Hershey

19104-4283

Philadelphia

A1B 3V6

St. John's

L8S 4J9

Hamilton

N6A 5B8

London

H2X 2P4

Montreal

04103

Leipzig

Unknown

Haifa

Jerusalem

Petah Tikva

Tel Litwinsky

0407

Oslo

416 85

Gothenburg

221 85

Lund

751 85

Uppsala

CB3 8RE

Cambridge

SO16 6YD

Southampton

BT12 7AB

Belfast

B9 5SS

Birmingham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Bayer

INDUSTRY

NCT00645788 - Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis | Biotech Hunter | Biotech Hunter