Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
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Layout table for eligibility information
Ages Eligible for Study:
6 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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