Randomized, double-blind, controlled pilot study on the safety of hypertonic saline solution as a preventive inhalation therapy for newborn CF patients
This study aims to evaluate whether 6% hypertonic saline solution is a safe and effective preventive therapeutic method for neonates and infants with CF. It is based on the results of a preclinical study and new non-invasive study endpoints, like MRI of the lung and the Lung Clearance Index (LCI), as established in other research activities of the disease area CF. The level of recruitment is 20 patients per year, i.e. 5 patients per recruitment center.
The study was started in Heidelberg in Summer 2012 as a monocentric study, sponsored by the Dietmar Hopp Foundation e.V.. However, CF is a rare disease which requires expansion of the patient recruitment. Sponsorship by the DZL Clinical Trial Board allows the study centers within BREATH, UGMLC and ARCN to be incorporated into the clinical research program to achieve a critical mass and thus establish an internationally competitive and leading preventive study within the DZL.
Prof. Dr. med. Dr. rer. nat. Burkhard Tümmler
Cooperating Partners: Airway Research Center North (ARCN),
Biomedical Research in Endstage And ObsTructive Lung Disease Hannover (BREATH), Comprehensive Pneumology Center (CPC) Munich, Universities of Giessen and Marburg Lung Center (UGMLC), Translational Lung Research Centre Heidelberg (TLRC-H)