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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01035853
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : March 21, 2013
Information provided by (Responsible Party):
PD Dr. Jochen G. Mainz, University of Jena

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Pseudomonas Aeruginosa Drug: Colistin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Intervention Details:
  • Drug: Colistin
    Sino-Nasal inhalation, approximately 1 ml / day in each nostril

Primary Outcome Measures :
  1. Decrease of Pseudomonas aeruginosa in Nasal lavage fluid [ Time Frame: 60 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01035853

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Tübingen, Baden-Würtemberg, Germany
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thüringen, Germany, 07743
Hamburg, Germany, 22763
Sponsors and Collaborators
University of Jena
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Study Chair: Jochen Mainz, M.D. University of Jena, Children`s hospital
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Responsible Party: PD Dr. Jochen G. Mainz, PD Dr., University of Jena Identifier: NCT01035853    
Other Study ID Numbers: colistin nasal cf pilot
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: March 21, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Pseudomonas Infections
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents