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

Sino-nasal Inhalation of Colistin Via the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Colonization of the Upper Airways With Pseudomonas Aeruginosa

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01035853

Enrollment

Registered

2009-12-21

Start date

2009-12-31

Completion date

2012-04-30

Last updated

2013-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Pseudomonas Aeruginosa

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.

Interventions

DRUGColistin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Decrease of Pseudomonas aeruginosa in Nasal lavage fluid	60 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026