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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa
• Intervention / Treatment: Drug: Colistin

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22763
    • CF-Zentrum
  • Baden-Würtemberg
    • Tübingen, Baden-Würtemberg, Germany
      • Universitäts-Kinderklinik
  • Thüringen
    • Jena, Thüringen, Germany, 07743
      • Mukoviszidosezentrum der Friedrich-Schiller-Universität

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Jena

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: December 17, 2009
• First Submitted That Met QC Criteria: December 18, 2009
• First Posted (ESTIMATE): December 21, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 21, 2013
• Last Update Submitted That Met QC Criteria: March 20, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pancreatic Diseases; Fibrosis; Cystic Fibrosis; Pseudomonas Infections; Anti-Infective Agents; Anti-Bacterial Agents; Colistin
• Other Study ID Numbers: colistin nasal cf pilot