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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01086839
First Posted: March 15, 2010
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PD Dr. Jochen G. Mainz, University of Jena
  Purpose

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 Intervention
Cystic Fibrosis Rhinosinusitis Drug: sodium chloride 6% Drug: sodium chloride 0,9%

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by PD Dr. Jochen G. Mainz, University of Jena:

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

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

Enrollment: 69
Study Start Date: March 2010
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086839


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:
Responsible Party: PD Dr. Jochen G. Mainz, PD Dr., University of Jena
ClinicalTrials.gov Identifier: NCT01086839     History of Changes
Other Study ID Numbers: NaCl 6.0%-nasal-CF
First Submitted: March 12, 2010
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:
Fibrosis
Cystic Fibrosis
Sinusitis
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