NCT01619657View on ClinicalTrials.gov

Preventive Inhalation of Hypertonic Saline in Infants With Cystic Fibrosis

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

November 30, 2016

Study Completion Date

October 31, 2017

Conditions
Cystic Fibrosis Lung Disease
Interventions
DRUG

6% Hypertonic Saline (HS), 4mL

Administered via inhalation twice daily for 52 weeks. The delivery system is a PARI LC SPRINT® Junior nebulizer with a baby bend, size-adapted PARI® Baby face mask size 0-3, connection tubing (2.2m) and a PARI JuniorBOY® SX compressor.

DRUG

0.9% Isotonic Saline (IS), 4mL

Administered via inhalation twice daily for 52 weeks. The delivery system is a PARI LC SPRINT® Junior nebulizer with a baby bend, size-adapted PARI® Baby face mask size 0-3, connection tubing (2.2m) and a PARI JuniorBOY® SX compressor.

Trial Locations (4)

23538

University Children's Hospital Schleswig-Holstein, Lübeck

30625

Medizinische Hochschule Hannover, Hanover

35392

University Hospital Gießen and Marburg GmbH, Giessen

69120

University Children's Hospital Heidelberg, Cystic Fibrosis Centre, Heidelberg

Sponsors
All Listed Sponsors
collaborator

German Center for Lung Research

OTHER

lead

Heidelberg University

OTHER