Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
NCT ID: NCT01086839
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2010-03-31
2013-06-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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sodium chloride 6%
Cross-Over! "experimental" (days 1 - 28), then Wash-Out (28 days),then "placebo comparator" (days 57 - 85).
sodium chloride 6%
* one ampoule sodium chloride 6% per day
* inhalation use
* for 28 days
sodium chloride 0,9%
Cross-Over! "placebo comparator" (days 1 - 28), then Wash-Out (28 days),then "experimental" (days 57 - 85).
sodium chloride 0,9%
* one ampoule sodium chloride 0,9% per day
* inhalation use
* for 28 days
Interventions
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sodium chloride 6%
* one ampoule sodium chloride 6% per day
* inhalation use
* for 28 days
sodium chloride 0,9%
* one ampoule sodium chloride 0,9% per day
* inhalation use
* for 28 days
Eligibility Criteria
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Inclusion Criteria
* 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 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
8 Years
ALL
No
Sponsors
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University of Jena
OTHER
Responsible Party
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PD Dr. Jochen G. Mainz
PD Dr.
Principal Investigators
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Jochen Mainz, M.D.
Role: STUDY_CHAIR
University of Jena
Locations
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Zentrum für Kinder- und Jugendmedizin
Heidelberg, Baden Würtemberg, Germany
Universitäts-Kinderklinik
Tübingen, Baden-Wurttemberg, Germany
Medizinische Klinik Innenstadt
München, Bavaria, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany
Zentrum für Kinder- und Jugendmedizin
Greifswald, Brandenburg, Germany
J.W. Goethe Universität - Abtl. Pneumologie
Frankfurt am Main, Hesse, Germany
Klinik für Kinder- und Jugendmedizin
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum
Leipzig, Saxony, Germany
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thuringia, Germany
CF-Zentrum
Hamburg, , Germany
Countries
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References
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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, Kading M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tummler 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, Schadlich K, Koitschev A, Koitschev C, Riethmuller 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, Schadlich K, Schien C, Michl R, Schelhorn-Neise P, Koitschev A, Koitschev C, Keller PM, Riethmuller 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.
Mainz JG, Schumacher U, Schadlich K, Hentschel J, Koitschev C, Koitschev A, Riethmuller 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.
Other Identifiers
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NaCl 6.0%-nasal-CF
Identifier Type: -
Identifier Source: org_study_id