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

• ClinicalTrials.gov Identifier: NCT01086839
• Recruitment Status: Completed
• First Posted: March 15, 2010
• Last Update Posted: December 2, 2014
• Sponsor: University of Jena
• Information provided by (Responsible Party): PD Dr. Jochen G. Mainz, University of Jena

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cystic Fibrosis; Rhinosinusitis	Drug: sodium chloride 6%; Drug: sodium chloride 0,9%	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: March 2010
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: sodium chloride 6%; Cross-Over! "experimental" (days 1 - 28), then Wash-Out (28 days),then "placebo comparator" (days 57 - 85).	Drug: sodium chloride 6%; one ampoule sodium chloride 6% per day; inhalation use; for 28 days
Placebo Comparator: sodium chloride 0,9%; 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 0,9% per day; inhalation use; for 28 days

Outcome Measures

Primary Outcome Measures :

1. Changes in the Sino-nasal-outcome test SNOT-20 adapt CF [ Time Frame: days 1, 29, 57 and 85 ]

Secondary Outcome Measures :

1. Changes in the nasal lavage fluid and in the serological markers of inflammation [ Time Frame: days 1, 29, 57 and 85 ]

Eligibility Criteria

• Ages Eligible for Study: 8 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Germany

Zentrum für Kinder- und Jugendmedizin

Heidelberg, Baden Würtemberg, Germany, 69120

Universitäts-Kinderklinik

Tübingen, Baden-Württemberg, Germany

Medizinische Klinik Innenstadt

München, Bayern, Germany, 80336

Universitätsklinikum Würzburg

Würzburg, Bayern, Germany, 97080

Zentrum für Kinder- und Jugendmedizin

Greifswald, Brandenburg, Germany, 17487

J.W. Goethe Universität - Abtl. Pneumologie

Frankfurt, Hessen, Germany, 60590

Klinik für Kinder- und Jugendmedizin

Münster, Nordrhein-Westfalen, Germany, 48149

Universitätsklinikum

Leipzig, Sachsen, Germany, 04103

Mukoviszidosezentrum der Friedrich-Schiller-Universität

Jena, Thüringen, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany, 13353

CF-Zentrum

Hamburg, Germany

Sponsors and Collaborators

University of Jena

Investigators

• Study Chair: Jochen Mainz, M.D.; University of Jena

More Information

Publications:

Mainz JG, Koitschev A. Management of chronic rhinosinusitis in CF. J Cyst Fibros. 2009 Jun;8 Suppl 1:S10-4. doi: 10.1016/S1569-1993(09)60005-9.

Mainz JG, Naehrlich L, Schien M, Käding M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tümmler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.

Mainz JG, Schien C, Schiller I, Schädlich K, Koitschev A, Koitschev C, Riethmüller J, Graepler-Mainka U, Wiedemann B, Beck JF. Sinonasal inhalation of dornase alfa administered by vibrating aerosol to cystic fibrosis patients: a double-blind placebo-controlled cross-over trial. J Cyst Fibros. 2014 Jul;13(4):461-70. doi: 10.1016/j.jcf.2014.02.005. Epub 2014 Mar 1.

Mainz JG, Schädlich K, Schien C, Michl R, Schelhorn-Neise P, Koitschev A, Koitschev C, Keller PM, Riethmüller J, Wiedemann B, Beck JF. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study. Drug Des Devel Ther. 2014 Feb 10;8:209-17. doi: 10.2147/DDDT.S54064. eCollection 2014.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mainz JG, Schumacher U, Schädlich K, Hentschel J, Koitschev C, Koitschev A, Riethmüller J, Prenzel F, Sommerburg O, Wiedemann B, Staab D, Gleiber W, Fischer R, Beck JF, Arnold C; Cooperators. Sino nasal inhalation of isotonic versus hypertonic saline (6.0%) in CF patients with chronic rhinosinusitis - Results of a multicenter, prospective, randomized, double-blind, controlled trial. J Cyst Fibros. 2016 Nov;15(6):e57-e66. doi: 10.1016/j.jcf.2016.05.003. Epub 2016 Jun 5.

• Responsible Party: PD Dr. Jochen G. Mainz, PD Dr., University of Jena
• ClinicalTrials.gov Identifier: NCT01086839
• Other Study ID Numbers: NaCl 6.0%-nasal-CF
• First Posted: March 15, 2010
• Last Update Posted: December 2, 2014
• Last Verified: November 2014

Keywords provided by PD Dr. Jochen G. Mainz, University of Jena:

Cystic Fibrosis; chronic rhinosinusitis

Additional relevant MeSH terms:

Cystic Fibrosis; Sinusitis; Fibrosis; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases