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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cystic Fibrosis, Rhinosinusitis

Intervention / Treatment
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* Drug: sodium chloride 6%
* Drug: sodium chloride 0,9%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sodium chloride 6%<br>Cross-Over! experimental (days 1 - 28), then Wash-Out (28 days),then placebo comparator (days 57 - 85). | Drug: sodium chloride 6%<br>* one ampoule sodium chloride 6% per day inhalation use for 28 days<br>|
| Placebo Comparator: sodium chloride 0,9%<br>Cross-Over! placebo comparator (days 1 - 28), then Wash-Out (28 days),then experimental (days 57 - 85). | Drug: sodium chloride 0,9%<br>* one ampoule sodium chloride 0,9% per day inhalation use for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Sino-nasal-outcome test SNOT-20 adapt CF |  | days 1, 29, 57 and 85 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the nasal lavage fluid and in the serological markers of inflammation |  | days 1, 29, 57 and 85 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, chronic rhinosinusitis