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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01086839
Date of registration: 12/03/2010
Prospective Registration: Yes
Primary sponsor: University of Jena
Public title: Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
Scientific 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
Date of first enrolment: March 2010
Target sample size: 69
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01086839
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Germany
Contacts
Name:     Jochen Mainz, M.D.
Address: 
Telephone:
Email:
Affiliation:  University of Jena
Key inclusion & exclusion 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



Age minimum: 8 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Rhinosinusitis
Intervention(s)
Drug: sodium chloride 6%
Drug: sodium chloride 0,9%
Primary Outcome(s)
Changes in the Sino-nasal-outcome test SNOT-20 adapt CF [Time Frame: days 1, 29, 57 and 85]
Secondary Outcome(s)
Changes in the nasal lavage fluid and in the serological markers of inflammation [Time Frame: days 1, 29, 57 and 85]
Secondary ID(s)
NaCl 6.0%-nasal-CF
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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