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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086839
• Other study ID #: NaCl 6.0%-nasal-CF
• Status: Completed
• Phase: N/A
• First received: March 12, 2010
• Last updated: November 28, 2014
• Start date: March 2010
• Est. completion date: June 2013

Study information

• Verified date: November 2014
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Rhinosinusitis
• Sinusitis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	J.W. Goethe Universität - Abtl. Pneumologie	Frankfurt	Hessen
Germany	Zentrum für Kinder- und Jugendmedizin	Greifswald	Brandenburg
Germany	CF-Zentrum	Hamburg
Germany	Zentrum für Kinder- und Jugendmedizin	Heidelberg	Baden Würtemberg
Germany	Mukoviszidosezentrum der Friedrich-Schiller-Universität	Jena	Thüringen
Germany	Universitätsklinikum	Leipzig	Sachsen
Germany	Medizinische Klinik Innenstadt	München	Bayern
Germany	Klinik für Kinder- und Jugendmedizin	Münster	Nordrhein-Westfalen
Germany	Universitäts-Kinderklinik	Tübingen	Baden-Württemberg
Germany	Universitätsklinikum Würzburg	Würzburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Sino-nasal-outcome test SNOT-20 adapt CF		days 1, 29, 57 and 85	No
Secondary	Changes in the nasal lavage fluid and in the serological markers of inflammation		days 1, 29, 57 and 85	No