Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01035853
• Date of registration: 17/12/2009
• Prospective Registration: No
• Primary sponsor: University of Jena
• Public title: Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
• Scientific title: Sino-nasal Inhalation of Colistin Via the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Colonization of the Upper Airways With Pseudomonas Aeruginosa
• Date of first enrolment: December 2009
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01035853
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Jochen Mainz, M.D.
• Affiliation: University of Jena, Children`s hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- subject has a confirmed diagnosis of cystic fibrosis

- detection of P. aeruginosa in nasal lavage (culture) with chronic P.a. colonization
of the lung (from day -28)

- informed consent of the patients or parents

- subject >= 6 years

- subject is able to comply with the inhalation procedures and nasal lavage procedures
scheduled in the protocol

- women of childbearing potential are only included into the study, if they are using
an effective method of birth control during the protocol

Exclusion 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 ear, nose, and throat surgery within 3 months prior to study

- subject shows signs of nasal bleeding

- subject has an ear drum perforation

- subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with
need of additional systemic antibiotic therapy against pseudomonas aeruginosa

- subject is unlikely to comply with the procedures scheduled in the protocol

- subject has a known allergic reaction to the medication

- subject is pregnant or breastfeeding

- subject participates in another clinical trial within 30 days prior to study entry or
30 days after end of the study.

- systemic (oral or intravenous) antibiotic treatment against P.a. 14 days prior to the
inclusion and during the study



Age minimum: 6 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Pseudomonas Aeruginosa

Intervention(s)

Drug: Colistin

Primary Outcome(s)

Decrease of Pseudomonas aeruginosa in Nasal lavage fluid [Time Frame: 60 days]

Secondary ID(s)

colistin nasal cf pilot

Source(s) of Monetary Support

Please refer to primary and secondary sponsors