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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PD Dr. Jochen G. Mainz, University of Jena
ClinicalTrials.gov Identifier:
NCT01035853
First received: December 17, 2009
Last updated: March 20, 2013
Last verified: March 2013
History of Changes

December 17, 2009
March 20, 2013
December 2009
April 2012   (final data collection date for primary outcome measure)
Decrease of Pseudomonas aeruginosa in Nasal lavage fluid [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Decrease of Pseudomonas aeruginosa bacterial count in nasal lavage fluid [ Time Frame: day +1, day +30, day +60 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01035853 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cystic Fibrosis
  • Pseudomonas Aeruginosa
Drug: Colistin
Sino-Nasal inhalation, approximately 1 ml / day in each nostril
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01035853
colistin nasal cf pilot
No
PD Dr. Jochen G. Mainz, University of Jena
University of Jena
Not Provided
Study Chair: Jochen Mainz, M.D. University of Jena, Children`s hospital
University of Jena
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP