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

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.

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Key information

Conditions

Cystic Fibrosis Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Gram-Negative Bacterial Infections Infant, Newborn, Diseases Infections Lung Diseases Pancreatic Diseases Pseudomonas Aeruginosa Pseudomonas Infections Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitäts-Kinderklinik, Tübingen, Baden-Würtemberg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colistin

Drug

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

Primary outcomes

Decrease of Pseudomonas aeruginosa in Nasal lavage fluid

Time frame: 60 days

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Dec 21, 2009
Registry last updated: Mar 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed