Long Term Administration of Inhaled Mannitol in Cystic Fibrosis

PHASE3CompletedINTERVENTIONAL
Enrollment

318

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

April 30, 2010

Study Completion Date

November 30, 2010

Conditions
Cystic Fibrosis
Interventions
DRUG

inhaled mannitol

400 mg BD for 26 + 26 weeks

DRUG

Placebo comparator

BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase

Trial Locations (53)

1090

Hopital Universitaire Reine Fabiola, Brussels

UZ Brussel Laarbeeklan 101, Brussels

1900

Hospital de Ninos Superiora Sor Maria Ludovica de La Plata, La Plata

2650

Pediatrics Respiratory Medicine, Edegem

3000

UZ Gasthuisberg, Leuven

4102

Maine Pediatric Specialty Group, Portland

5000

Clinica Universitaria Privada Reina Fabiola - Universidad Cotolica de Cordoba, Córdoba

Hospital de Ninos del la Santisima Trinidad, Córdoba

5519

Hospital Pediatrico Dr Humberto J Notti, Villa Nueva

8000

Hospital Interzonal Dr Jose Penna Bahia Blanca, Bahía Blanca

14222

Women and Childrens Hospital of Buffalo, Buffalo

19134

St Christopher's Hospital for Children, Philadelphia

21287

John Hopkins, Baltimore

23298

Pediatric Research, VCU Medical Centre, Richmond

Virginia Commonwealth University, Richmond

29425

Medical University of SC, Charleston

32207

Nemours Childrens Clinic, Jacksonville

32801

Nemours Children's Clinic Orlando, Orlando

33136

Batchelor Children's Research Institute - University of Miami, Miami

38105

Le Bonheur Children's Medical Center, Memphis

43606

The Toledo Hospital and Toledo Childrens Hospital, Toledo

44093

Hopital Mere-Enfant, Nantes

53972

University of Wisconsin, Madison

57117

Sanford Children's Specialty Clinic, Sioux Falls

58103

University of Washington medical centre, Seattle

59037

Hopital Jeanne de Flandre, Lille

60611

Northwestern Memorial Hospital, Chicago

62114

Massachusetts General Hospital, Boston

65212

University of Missouri, Columbia

66106

Central Connecticut Cystic Fibrosis Center, Hartford

67098

Hopital de Hautepierre, Strasbourg

69677

Hopital Femme-Mere-Enfents, Bron

72076

Universitats Kinderklinik Tubungen Wurzburg, Tübingen

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75019

Hopital Robert Debre, Paris

77030

Baylor College of Medicine, Houston

78157

Hopital Andre Mignot, Le Chesnay

78212

Alamo Clinical Research Associates, San Antonio

78723

Children's Chest Associates of Austin, Austin

80336

University of Munich Medizinischen Klinik Innenstadt, München

83712

St Lukes CF Center of Idaho, Idaho City

85724

University of Arizona, Tucson

97080

Universitats Kinderklinik Wurzburg, Würzburg

71130-3932

Louisiana State University Health Sciences Center, Shreveport

68198-5300

Nebraska Medical Center - Nebraska Regional CF Center, Omaha

78229-3900

Christus Santa Rosa Children's Hospital Cystic Fibrosis Center, San Antonio

C1425EFD

Hospital de Ninos Dr Ricardo Gutierrez, Pediatria, CABA

C1270AAN

Hospital Gral. de Ninos Pedro de Elizalde, Ciudad Autonoma

C1426AAL

Atención Integral en Reumatologia (AIR), Buenos Aires

T2N4N1

Foothills medical center, Calgary

B3H3A7

QEII Health Sciences Center, Halifax

N6A1V2

The Children's Asthma Clinic, London

1100DD

Academic Medical Centre, Amsterdam

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

ethica Clinical Research Inc.

INDUSTRY

collaborator

Europe: KasaConsult bvba, Hoegaarden, Belgium

INDUSTRY

collaborator

Resolution Latin America

OTHER

lead

Syntara

INDUSTRY