Clinical trial NCT01086839: Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Rhinosinusitis
Keywords: Cystic Fibrosis
chronic rhinosinusitis
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2010-03-15
Enrollment: 69
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Changes in the Sino-nasal-outcome test SNOT-20 adapt CF
timeFrame: days 1, 29, 57 and 85
Secondary outcomes:
measure: Changes in the nasal lavage fluid and in the serological markers of inflammation
timeFrame: days 1, 29, 57 and 85
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Zentrum für Kinder- und Jugendmedizin
state: Baden Würtemberg
city: Tübingen
country: Germany
facility: Universitäts-Kinderklinik
state: Baden-Württemberg
city: München
country: Germany
facility: Medizinische Klinik Innenstadt
state: Bayern
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Greifswald
country: Germany
facility: Zentrum für Kinder- und Jugendmedizin
state: Brandenburg
city: Frankfurt
country: Germany
facility: J.W. Goethe Universität - Abtl. Pneumologie
state: Hessen
city: Münster
country: Germany
facility: Klinik für Kinder- und Jugendmedizin
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Universitätsklinikum
state: Sachsen
city: Jena
country: Germany
facility: Mukoviszidosezentrum der Friedrich-Schiller-Universität
state: Thüringen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Hamburg
country: Germany
facility: CF-Zentrum
Study officials:
affiliation: University of Jena
name: Jochen Mainz, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.