A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects

PHASE3CompletedINTERVENTIONAL
Enrollment

423

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

February 28, 2017

Study Completion Date

February 28, 2017

Conditions
Cystic Fibrosis
Interventions
DRUG

Inhaled mannitol

Inhaled mannitol 400 mg BD for 26 weeks

DRUG

Placebo Comparator: Arm B - Control

Placebo Comparator: Arm B - Control BD for 26 weeks

Trial Locations (100)

1750

Hospital del Tórax Cetrángolo, Buenos Aires

4000

CHR Citadelle, Liège

4001

St. Augustine's Medical Centre 2, Durban

4101

Mater Adult Hospital, Brisbane

7700

University of Cape Town Lung Institute, Cape Town

8000

Hospital Regional Español de Bahía Blanca, Buenos Aires

8011

Canterbury Respiratory Research Group, Christchurch

10003

The Cystic Fibrosis Center Beth Israel Medical Center, New York

10595

Dr Allen Dozor, Valhalla

11040

Long Island Jewish Medical Center, New Hyde Park

21287

John Hopkins, Baltimore

28046

Hospital Universitaro La Paz, Madrid

29203

One Richland Medical Park, Columbia

29425

Medical University of SC, Charleston

31096

Pediatrics Pulmonary Department Rambam Healthcare Campus, Haifa

32204

Dr Mitchell Rothstein, Jacksonville

32803

Central Florida Pulmonary Group, P.A., Orlando

33006

Hospital Universitario Central de Asturias, Oviedo

33136

University of Miami, Miami

33606

Tampa General Hospital, Tampa

36608

Dr Lawrence Sinde, Mobile

39216

University of Mississippi Medical Center, Jackson

40202

Kosair Charities Pediatric Clinical Research Unit, Louisville

41013

Hospital Virgen del Rocio Hospital Unidad de Fibrosis Quistica, Seville

43205

Nationwide Children's Hospital, Columbus

43606

The Toledo Hospital and Toledo Childrens Hospital, Toledo

44100

Instituto Jaliscience de Investigacion Clinica, Guadalajara

44220

Unidad Médica de Occidente, Guadalajara

44308

Akron Children's Hospital, Akron

45404

The Children's Medical Center of Dayton, Dayton

46026

Hospital Universitario La Fe Neumología, Valencia

49044

Dnipropetrovsk State Medical Academy, Faculty Theraphy and Endocrinology Chair, Dnipropetrovsk

49202

Schneider Children's Medical Center of Israel, Petah Tikva

49503

Spectrum Health Offices of Research Administration, Grand Rapids

50047

"Department of Pulmonology and Thoracic Surgery of Public Institution Kryvyy Rig City Clinical Hospital # 8", Kryvyy Rig

55455

University of Minnesota, Minneapolis

60025

Cystic Fibrosis Center of Chicago, Glenview

60153

Loyola University Medical Center, Maywood

61537

Illinois Lung Institute, Peoria

62114

Massachusetts General Hospital, Boston

63143

Dr Joseph Ojile, St Louis

64081

University of Kansas Hospital, Kansas City

64460

CEPREP- Hospital Universitario, Monterrey

69600

"Hospital Department of Municipal Institution Zaporizhzhya Regional Clinical Hospital", Zaporizhzhya

72205

University of Arkansas for Medical Sciences, Little Rock

73000

"Municipal Institution Kherson City Clinical Hospital n.a. Afanasiy and Olha Tropin", Kherson

73104

Pediatric Pulmonary & CF Center, Oklahoma City

73112

Dr Santiago Reyes, Oklahoma City

85724

University of Arizona, Tucson

90806

Pediatric Pulmonology, Long Beach

95817

University of CA, Davis, Sacramento

97227

Pediatric Clinic, Portland

98195

University of Washington, Seattle

105077

Pulmonology Research Institute, Moscow

150010

Clinical Hospital# 2, Yaroslavl

396170

Kremenchuk First City Hospital n.a. O.T.Bogaevskyy, Kremenchuk

400371

"Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca", Cluj-Napoca

600023

Mikhail Smirnov, Vladimir

656045

Tatiana I. Martynenko, Barnaul

700115

Spitalul Clinic de Pneumoftiziologie Lasi, Lasi

06102

Hartford Hospital, Hartford

03110

Dartmouth-Hitchcock Specialty Care, Bedford

45267-0564

University of Cincinnati, Cincinnati

M5500CCG

Insares, Mendoza

2401 (8001)

Hospital Interzonal General de Agudos Dr. Jose Penna, Bahía Blanca

1900 (5000)

Hospital San Roque, Córdoba

B-1090

UZ VUB, Brussels

B-3000

UZ Leuven, Leuven

B3H 3A7

QEII Health Sciences Center, Halifax

H2X 2L0

Institut de recherches cliniques de Montréal, Montreal

K1H 8L6

The Ottawa Hospital, General Campus, Ottawa

625 00

FN Brno, Brno

H-1125

Országos Korányi Tbc, Budapest

H-1031

Klinikai Farmakológiai Központ, Debrecen

H-7257

Mosdós Tüdőgyógyintézet, Mosdós

H-2045

Törökbálint Tüdőgyógyintézet, Törökbálint

Unknown

Spedali Civili Brescia, Brescia

IRCCS Ca' Granda Ospedale Maggiore Policlinico Mil, Milan

AOU San Luigi Gonzaga, Orbassano

Aziendao Spedaliera Universitaria, Parma

Cystic Fibrosis Center Hospital San Carlo, Potenza

Centro Fibrosi Cistica Policlinico Umberto I, Roma

Azienda Ospedaliera Universitaria Integratadi Verona, Verona

Greenlane Hospital, Auckland

Otago Respiratory Research Unit, Dunedin Hospital, Dunedin

Research and Clinical Center of interstitial and orphan lung diseases, Saint Petersburg

Hospital Universitario Virgen de la Arrixaca, El Palmar

CP 6700

Arke Estudios Clinicos S.A, Mexico City

80-308

Szpital Dziecięcy Polanki im. M. Płażyńskiego w Gdańsku sp., Gdansk

58-540

Centrum Medyczne Karpacz SA, Karpacz

25-381

Wojewodzki Specjalistyczny Szpital Dzieciecy im. W. Buszkowskiego, Kielce

93-513

Wojewodzki Szpital Specjalistyczny im., Lodz

60-569

Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu, Poznan

34-700

Sanatorium Cassia-Villa Medica S.C., Rabka-Zdrój

35-612

Podkarpacki Osrodek Pulmonologii i Alergologii, Rzeszów

020395

"Institutul pentru Ocrotirea Mamei si Copilului Alfred Rusescu", Bucharest

050159

"Institutul de Pneumoftiziologie Marius Nasta Bucuresti, Sectia Clinica Pneumologie V", Bucharest

975 17

Oddelenie pneumológie a ftizeológie, Banská Bystrica

825 56

Imuno-alergologická ambulancia, Bratislava

040 11

Detská fakultná nemocnica Košice, Košice

Sponsors

Lead Sponsor

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Syntara

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