asale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot

Conditions: subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
MedDRA version: 9.1Level: LLTClassification code 10011762Term: Cystic fibrosis

Registration Number: EUCTR2008-007877-19-DE

Lead Sponsor: niversity of Jena

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 14

Inclusion Criteria

1. Subject has a confirmed diagnosis of cystic fibrosis based on:
3 positive sweat chloride tests and/or genetic characterisation
2. detection of P. aeruginosa in nasal lavage (culture) with chronic P.
aeruginosa colonization of the lung (from day – 28)
3. informed consent of the patients or parents
4. Subject >= 6 years
5. Subject is able to comply with the inhalation procedures and nasal
lavage procedures scheduled in the protocol.
6. Women of childbearing potential are only included into the study, if they
are using an effective method of birth control during the protocol (e.g.
implants, combined oral contraceptives, injectables, some IUDs, sexual
abstinence or vasectomised partner)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.subject has a critical condition defined as:
FEV1 < 30% and / or
SaO2 < 93% without O2-substitution; need of O2-substitution
2.Subject had an ENT surgery within 3 months prior to study
3.Subject shows signs of nasal bleeding
4.Subject has an ear drum perforation
5.Subject had an acute rhinosinusitis or a pulmonary exacerbation at study
entry with need of additional systemic antibiotic therapy against
pseudomonas aerug.
6.Subject is unlikely to comply with the procedures scheduled in the protocol
7.Subject has contraindications and known side effects to the medication
8.Subject is pregnant or breastfeeding
9.Subject participates in another clinical trial within 30 days prior to study
entry or 30 days after end of the study.
10.Systemic (oral or intravenous) antibiotic treatment against P.a. 14 days
prior to the inclusion and during the study