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

• Conditions: subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways

• Registration Number: EUCTR2008-000164-17-DE
• Lead Sponsor: niversity of Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-26
• Last Update Posted: 15 April 2013

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 is older than 7 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 a known allergic reaction 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
11.If serum level of tobramycin is above 2 mg/l one hour after inhalation,
subject has to withdraw the participation in the study.
12.progressed renal insufficiency
13.severe damage of the N. acusticus
14.dissiness (potential damage of N. vestibularis)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid;Secondary Objective: 1.drug safety of nasal Tobramycin (only for pilot-study)<br>- Serum levels in non-toxic range <br>- mucosal tolerance <br>2.Changes of the Sino-nasal-outcome test SNOT-20 adapt CF <br>/ patient`s diary<br>3.detection of P. aeruginosa in sputum / througt swap<br>4.Genotyping of P. aeruginosa<br>5.Changes in rhinoscopic findings (size of polyps, mucosa, secretions)<br>6.Changes in rhinomanometric findings (pilot study)<br>7.Cytology, Cytokines in nasal lavage<br>8.Incidence of rhinosinusitic and pulmonal exazerbations;Primary end point(s): Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid