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Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Cystic Fibrosis Clinical Trial

Official title:
Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01086839
Study type Interventional
Source University of Jena
Contact
Status Completed
Phase N/A
Start date March 2010
Completion date June 2013
View Details
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