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

University of Jena

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa

Treatments: Drug: Colistin

Study type: Interventional

Funder types: Other

Identifiers

NCT01035853

colistin nasal cf pilot

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)