NCT01086839

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: University of Jena · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis
• Rhinosinusitis

Interventions

Type	Name	Description
DRUG	sodium chloride 6%	* one ampoule sodium chloride 6% per day * inhalation use * for 28 days
DRUG	sodium chloride 0,9%	* one ampoule sodium chloride 0,9% per day * inhalation use * for 28 days

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-04-01
• Completion: 2013-06-01
• First posted: 2010-03-15
• Last updated: 2014-12-02

Locations

11 sites across 1 country: Germany