Back to resultsSino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
Primary Purpose
Cystic Fibrosis, Pseudomonas Aeruginosa
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Colistin
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
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
Sites / Locations
- Universitäts-Kinderklinik
- Mukoviszidosezentrum der Friedrich-Schiller-Universität
- CF-Zentrum
Outcomes
Primary Outcome Measures
Decrease of Pseudomonas aeruginosa in Nasal lavage fluid
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01035853
Brief Title
Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Pseudomonas Aeruginosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Colistin
Intervention Description
Sino-Nasal inhalation, approximately 1 ml / day in each nostril
Primary Outcome Measure Information:
Title
Decrease of Pseudomonas aeruginosa in Nasal lavage fluid
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Mainz, M.D.
Organizational Affiliation
University of Jena, Children's hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Universitäts-Kinderklinik
City
Tübingen
State/Province
Baden-Würtemberg
Country
Germany
Facility Name
Mukoviszidosezentrum der Friedrich-Schiller-Universität
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07743
Country
Germany
Facility Name
CF-Zentrum
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
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