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

NCT01086839 | Completed

• 1 other identifier: NaCl 6.0%-nasal-CF
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 11

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.

Conditions

Cystic Fibrosis; Rhinosinusitis

Keywords

Cystic Fibrosis; chronic rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• Changes in the Sino-nasal-outcome test SNOT-20 adapt CF

  days 1, 29, 57 and 85

Secondary Outcomes (1)

• Changes in the nasal lavage fluid and in the serological markers of inflammation

  days 1, 29, 57 and 85

Study Arms (2)

sodium chloride 6%

EXPERIMENTAL

Cross-Over! "experimental" (days 1 - 28), then Wash-Out (28 days),then "placebo comparator" (days 57 - 85).

Drug: sodium chloride 6%

sodium chloride 0,9%

PLACEBO COMPARATOR

Cross-Over! "placebo comparator" (days 1 - 28), then Wash-Out (28 days),then "experimental" (days 57 - 85).

Drug: sodium chloride 0,9%

Interventions

sodium chloride 6% DRUG

* one ampoule sodium chloride 6% per day * inhalation use * for 28 days

sodium chloride 6%

sodium chloride 0,9% DRUG

* one ampoule sodium chloride 0,9% per day * inhalation use * for 28 days

sodium chloride 0,9%

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jena: lead

Study Sites (11)

Zentrum für Kinder- und Jugendmedizin

Heidelberg, Baden Würtemberg, 69120, Germany

Location

Universitäts-Kinderklinik

Tübingen, Baden-Wurttemberg, Germany

Location

Medizinische Klinik Innenstadt

München, Bavaria, 80336, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

Location

Zentrum für Kinder- und Jugendmedizin

Greifswald, Brandenburg, 17487, Germany

Location

J.W. Goethe Universität - Abtl. Pneumologie

Frankfurt am Main, Hesse, 60590, Germany

Location

Klinik für Kinder- und Jugendmedizin

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitätsklinikum

Leipzig, Saxony, 04103, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

Location

Mukoviszidosezentrum der Friedrich-Schiller-Universität

Jena, Thuringia, Germany

Location

CF-Zentrum

Hamburg, Germany

Location

Related Publications (5)

• 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.

  PMID: 19460681 BACKGROUND

• 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.

  PMID: 19282318 BACKGROUND

• 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.

  PMID: 24594542 BACKGROUND

• 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.

  PMID: 24596456 BACKGROUND

• 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.

  PMID: 27267518 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Rhinosinusitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jochen Mainz, M.D.

  University of Jena

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: March 12, 2010
• First Posted: March 15, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

DE (11)