Rhinosinusitis disorders are almost regularly associated to Cystic Fibrosis (CF). The basic defect in CF is a dysfunction of chloride channels in exocrine glands which equally concerns upper airway mucosa. It leads to retention of secretions and consecutive chronic inflammation with bacterial superinfection. In CF rhinosinusitis can restrict quality of life, give cause to repeated ear, nose, and throat (ENT) surgery and accelerate disease progression by bacterial acquisition into the airways. The multicenter, randomized, double-blind, placebo-controlled, prospective clinical trial aims at the evaluation of a sino-nasal inhalation of sodium chloride 6% compared to isotonic saline with respect to ENT-related quality of life which is influenced by mucus retention and the resulting inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
* one ampoule sodium chloride 6% per day * inhalation use * for 28 days
* one ampoule sodium chloride 0,9% per day * inhalation use * for 28 days
Zentrum für Kinder- und Jugendmedizin
Heidelberg, Baden Würtemberg, Germany
Universitäts-Kinderklinik
Tübingen, Baden-Wurttemberg, Germany
Medizinische Klinik Innenstadt
München, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Zentrum für Kinder- und Jugendmedizin
Greifswald, Brandenburg, Germany
J.W. Goethe Universität - Abtl. Pneumologie
Frankfurt am Main, Hesse, Germany
Klinik für Kinder- und Jugendmedizin
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum
Leipzig, Saxony, Germany
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thuringia, Germany
...and 1 more locations
Changes in the Sino-nasal-outcome test SNOT-20 adapt CF
Time frame: days 1, 29, 57 and 85
Changes in the nasal lavage fluid and in the serological markers of inflammation
Time frame: days 1, 29, 57 and 85
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