116
Participants
Start Date
March 24, 2015
Primary Completion Date
December 15, 2020
Study Completion Date
June 25, 2021
Active Treatment Group 7% Hypertonic Saline
"Drug: 7% Hypertonic Saline (HS) 4 mL of HS will be administered via inhalation twice daily for 48 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI compressor (PARI Vios® Pro in USA, PARI BOY SX in Australia and Europe).~Other Names:~Hyper-Sal™, inhaled saline"
Control Group 0.9% Isotonic Saline
"Drug: 0.9% Isotonic Saline (IS) 4 mL of IS will be administered via inhalation twice daily for 48 weeks The delivery system is the same as that for the test product.~Other Names: Normal saline"
Children's Hospital of Pittsburgh of UPMC, Pittsburgh
University of North Carolina at Chapel Hill, Chapel Hill
Ospedale Civile Maggiore, Verona
Riley Hospital for Children, Indianapolis
Washington University School of Medicine, St Louis
Children's Hospital of Colorado, Aurora
Oregon Health Sciences University, Portland
Seattle Children's Hospital, Seattle
Royal Women's and Children Hospital, Adelaide
Lady Cilento Children's Hospital, Brisbane
Royal Children's Hospital, Melbourne
John Hunter Children's Hospital, Newcastle
Children's Hospital at Westmead, Sydney
Sydney Children's Hospital at Randwick, Sydney
Perth Children's Hospital, West Perth
Universitair Ziekenhuis Children's Hospital, Brussels
UZ Leuven - Gasthuisberg Ziekenhuis, Leuven
Copenhagen University Hospital Rigshospitalet, Copenhagen
Hospice Civils de Lyon, Lyon
Hospital Robert Debre, Paris
Sophia Children's Hospital at Erasmus Medical Centre, Rotterdam
Hospital Universitari Vall d'Hebron, Barcelona
British Columbia Children's Hospital, Vancouver
Hospital for Sick Kids, Toronto
Bambini Gesu Children's Hospital, Roma
Cystic Fibrosis Foundation
OTHER
University of Washington, the Collaborative Health Studies Coordinating Center
OTHER