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

Not Applicable

Completed

• Conditions: Rhinosinusitis; Cystic Fibrosis
• Interventions: Drug: sodium chloride 6%; Drug: sodium chloride 0,9%

• Registration Number: NCT01086839
• Lead Sponsor: University of Jena

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-28
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Subject has a confirmed diagnosis of cystic fibrosis based on: 2 positive sweat chloride tests and/or genetic characterization
• Subject is 8 years of age or older
• informed consent of the patient or legal representative
• Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (failure rate <1% e.g. implants, combined oral contraceptives, injectables, some intrauterine devices, sexual abstinence or vasectomised partner)

Exclusion Criteria

• Subject has no chronic rhinosinusitis (European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS-criteria)
• Subject has a critical condition defined as: forced expiratory volume at one second < 30% and / or arterial oxygen saturation < 93% without O2-substitution; need of O2-substitution
• Subject had an ENT surgery within 6 months prior to study
• Subject participates in another clinical trial within 30 days prior to study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
sodium chloride 6%	sodium chloride 6%	Cross-Over! "experimental" (days 1 - 28), then Wash-Out (28 days),then "placebo comparator" (days 57 - 85).
sodium chloride 0,9%	sodium chloride 0,9%	Cross-Over! "placebo comparator" (days 1 - 28), then Wash-Out (28 days),then "experimental" (days 57 - 85).

Primary Outcome Measures

Name	Time	Method
Changes in the Sino-nasal-outcome test SNOT-20 adapt CF	days 1, 29, 57 and 85

Secondary Outcome Measures

Name	Time	Method
Changes in the nasal lavage fluid and in the serological markers of inflammation	days 1, 29, 57 and 85

Trial Locations

Locations (10)

Universitäts-Kinderklinik; 🇩🇪 Tübingen, Baden-Württemberg, Germany

Zentrum für Kinder- und Jugendmedizin; 🇩🇪 Greifswald, Brandenburg, Germany

Medizinische Klinik Innenstadt; 🇩🇪 München, Bayern, Germany

Klinik für Kinder- und Jugendmedizin; 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Mukoviszidosezentrum der Friedrich-Schiller-Universität; 🇩🇪 Jena, Thüringen, Germany

CF-Zentrum; 🇩🇪 Hamburg, Germany

J.W. Goethe Universität - Abtl. Pneumologie; 🇩🇪 Frankfurt, Hessen, Germany

Universitätsklinikum; 🇩🇪 Leipzig, Sachsen, Germany

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Bayern, Germany