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

NCT01035853 | Completed Phase 2

• 1 other identifier: colistin nasal cf pilot
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Decrease of Pseudomonas aeruginosa in Nasal lavage fluid

  60 days

Interventions

Colistin DRUG

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

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jena: lead

Study Sites (3)

Universitäts-Kinderklinik

Tübingen, Baden-Würtemberg, Germany

Location

Mukoviszidosezentrum der Friedrich-Schiller-Universität

Jena, Thuringia, 07743, Germany

Location

CF-Zentrum

Hamburg, 22763, Germany

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections

Interventions

Colistin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Study Officials

• Jochen Mainz, M.D.

  University of Jena, Children's hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: December 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 21, 2013

Record last verified: 2013-03

Locations

DE (3)