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

Phase 2

Completed

• Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa

• Registration Number: NCT01035853
• Lead Sponsor: University of Jena

Brief Summary

The purpose of this study is to determine whether the nasal inhalation of Colistin is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-20
• Last Update Posted: 2013-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Decrease of Pseudomonas aeruginosa in Nasal lavage fluid	60 days

Trial Locations

Locations (3)

Universitäts-Kinderklinik; 🇩🇪 Tübingen, Baden-Würtemberg, Germany

Mukoviszidosezentrum der Friedrich-Schiller-Universität; 🇩🇪 Jena, Thüringen, Germany

CF-Zentrum; 🇩🇪 Hamburg, Germany