Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

282

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

June 30, 2013

Conditions
Cystic Fibrosis
Interventions
DRUG

MP-376 (Levofloxacin Solution for Inhalation)

MP-376 (Aeroquin, Levofloxacin solution for Inhalation) 240 mg administered BID for 28-days treatment followed by 28 days off treatment

DRUG

TIS (Tobramycin Inhalation Solution)

Tobramycin Inhalation Solution administered BID over 3 consecutive cycles of 28-days treatment followed by 28 days off treatment

Trial Locations (130)

10003

New York

10032

New York

10595

Valhalla

11042

New Hyde Park

12208

Albany Medical College #2, Albany

Albany

13210

Syracuse

15224

Pittsburgh

17033

Hershey

19102

Philadelphia

19104

Philadelphia

19803

Wilmington

21287

Baltimore

22908

Charlottesville

23298

Richmond

23507

Norfolk

23708

Portsmouth

26506

Morgantown

27710

Durham

29203

Columbia

29425

Charleston

30322

Atlanta

31059

CRCM adulte Hôpital Larrey-CHU de Toulouse, Toulouse

31096

Rambam Medical Center, Haifa

32207

Jacksonville

32610

Gainesville

32801

Orlando

33076

Hôpital Pellegrin Enfants - CHU Bordeaux, Bordeaux

33136

Miami

33604

Hôpital Haut-Lévêque CHU de Bordeaux, Pessac

33606

Tampa

33701

St. Petersburg

34295

CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve, Montpellier

36608

Mobile

37232

Nashville

38105

Memphis

39216

Jackson

40202

Louisville

40536

Lexington

43202

Indianapolis

43205

Columbus

43606

Toledo

44308

Akron

45229

Cincinnati

45404

Dayton

46202

Indianapolis

48109

Ann Arbor

48201

Detroit

49202

Schneider Childrens Medical Center of Israel, Petah Tikva

49503

Grand Rapids

52621

Safra Childrens Hospital, Sheba Medical Center, Ramat Gan

53201

Milwaukee

53266

Milwaukee

55455

Minneapolis

57117

Sioux Falls

60025

Glenview

60614

Chicago

60637

Chicago

60714

Niles

61637

Peoria

63110

St Louis

64108

Kansas City

65020

New Haven

65212

Columbia

67214

Wichita

68105

Omaha

72202

Little Rock

73104

Oklahoma CF Center, Oklahoma City

73112

Oklahoma City

75014

Hôpital Cochin, Paris

75390

Dallas

75708

Tyler

75743

Hôpital Necker-Enfants Malades, Paris

76104

Fort Worth

77030

Houston

78212

San Antonio

78723

Austin

80045

Aurora

80206

Denver

83712

Boise

84132

Salt Lake City

85016

Phoenix

85724

Tucson

87131

Albuquerque

89107

Las Vegas

90027

Childrens Hospital, Los Angeles

90033

Los Angeles

90806

Long Beach

91240

Hadassah Medical Center Mount Scopus, Jerusalem

92037

La Jolla

92103

San Diego

92123

San Diego

92868

Orange

94115

San Francisco

94304

Palo Alto

94611

Oakland

95817

Sacramento

98105

Seattle

99508

Anchorage

06106

Hartford

04102

Portland

02114

Boston

02115

Boston

01655

Worcester

03756

Lebanon

03104

Manchester

07039

Livingston

07962

Morristown

05446

Colchester

Unknown

Charité Campus Virchow-Klinikum, Berlin

Universitätskinderklinik Dresden Mukoviszidose-Ambulanz, Dresden

Universitätsklinikum Essen, Essen

Katharina-Kasper Kliniken GmbH St. Elisabethen-Krankenhaus Medizinische Klinik, Frankfurt

Universitätsklinikum Frankfurt, Frankfurt

Universitätsklinik Gießen und Marburg GmbH Zentrum für Kinderheilkunde und Jugendmedizin, Gieben

Kinderärztliche Gemeinschaftspraxis Dr. H. E. Heuer, Dr. C. Runge, W. Sextro, Hamburg

Universitätsklinikum Kiel, Kiel

Dr. von Haunersches Kinderspital der Universität München Christiane Herzog Ambulanz, Munich

Ludwig-Maximilians Universität Klinikum Innenstadt, München

Universitätsklinik für Kinder- und Jugendmedizin, Tübingen

Cork University Hospital, Cork

Beaumont Hospital, Dublin

National Children's Hospital Tallaght, Dublin

St. Vincent's University Hospital, Dublin

BT9 7AB

Belfast City Hospital, Belfast

B95SS

Birmingham Heartlands Hospital, Birmingham

HU16 5JQ

Castle Hill Hospital, Cottingham

LS97TF

St James's University Hospital, Leeds

SE59RS

King's College Hospital, London

CF64 2XX

University Hospital Llandough, Penarth, Penarth

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Forest Laboratories

INDUSTRY

lead

Amgen

INDUSTRY