Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
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ClinicalTrials.gov Identifier: NCT01086839 |
Recruitment Status :
Completed
First Posted : March 15, 2010
Last Update Posted : December 2, 2014
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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 or disease | Intervention/treatment | Phase |
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Cystic Fibrosis Rhinosinusitis | Drug: sodium chloride 6% Drug: sodium chloride 0,9% | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69 participants |
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 |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
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Experimental: sodium chloride 6%
Cross-Over! "experimental" (days 1 - 28), then Wash-Out (28 days),then "placebo comparator" (days 57 - 85).
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Drug: sodium chloride 6%
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Placebo Comparator: sodium chloride 0,9%
Cross-Over! "placebo comparator" (days 1 - 28), then Wash-Out (28 days),then "experimental" (days 57 - 85).
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Drug: sodium chloride 0,9%
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- Changes in the Sino-nasal-outcome test SNOT-20 adapt CF [ Time Frame: days 1, 29, 57 and 85 ]
- Changes in the nasal lavage fluid and in the serological markers of inflammation [ Time Frame: days 1, 29, 57 and 85 ]

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Ages Eligible for Study: | 8 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Chair: | Jochen Mainz, M.D. | University of Jena |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | PD Dr. Jochen G. Mainz, PD Dr., University of Jena |
ClinicalTrials.gov Identifier: | NCT01086839 |
Other Study ID Numbers: |
NaCl 6.0%-nasal-CF |
First Posted: | March 15, 2010 Key Record Dates |
Last Update Posted: | December 2, 2014 |
Last Verified: | November 2014 |
Cystic Fibrosis chronic rhinosinusitis |
Cystic Fibrosis Sinusitis Fibrosis 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 |