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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01086839
• Date of registration: 12/03/2010
• Prospective Registration: No
• 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.
• 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