An interventional study of sodium chloride 6% and sodium chloride 0,9% in Cystic Fibrosis and Rhinosinusitis, sponsored by University of Jena. Completed at 11 sites in Germany. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2014-12-02.
Sponsored by University of Jena · Not applicable, Interventional, and Treatment
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.
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's enrollment of 69 is above the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →University of Jena is the lead sponsor of 89 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cross-Over! "experimental" (days 1 - 28), then Wash-Out (28 days),then "placebo comparator" (days 57 - 85).
Drug: sodium chloride 6%
Cross-Over! "placebo comparator" (days 1 - 28), then Wash-Out (28 days),then "experimental" (days 57 - 85).
Drug: sodium chloride 0,9%
* 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
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
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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University of Jena