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

NCT ID: NCT01035853

Last Updated: 2013-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-04-30

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.

Conditions

Cystic Fibrosis; Pseudomonas Aeruginosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Colistin

Sino-Nasal inhalation, approximately 1 ml / day in each nostril

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jena

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. Jochen G. Mainz

PD Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jochen Mainz, M.D.

Role: STUDY_CHAIR

University of Jena, Children's hospital

Locations

Universitäts-Kinderklinik

Tübingen, Baden-Würtemberg, Germany

Mukoviszidosezentrum der Friedrich-Schiller-Universität

Jena, Thuringia, Germany

CF-Zentrum

Hamburg, , Germany

Countries

Germany

Other Identifiers

colistin nasal cf pilot

Identifier Type: -

Identifier Source: org_study_id