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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
  Purpose

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 Intervention Phase
Cystic Fibrosis
Pseudomonas Aeruginosa
 Drug: Colistin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Decrease of Pseudomonas aeruginosa in Nasal lavage fluid [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Colistin
    Sino-Nasal inhalation, approximately 1 ml / day in each nostril
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035853

Locations
Germany
Universitäts-Kinderklinik
Tübingen, Baden-Würtemberg, Germany
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thüringen, Germany, 07743
CF-Zentrum
Hamburg, Germany, 22763
Sponsors and Collaborators
University of Jena
Investigators
Study Chair: Jochen Mainz, M.D. University of Jena, Children`s hospital
  More Information

No publications provided

Responsible Party: PD Dr. Jochen G. Mainz, PD Dr., University of Jena
ClinicalTrials.gov Identifier: NCT01035853     History of Changes
Other Study ID Numbers: colistin nasal cf pilot
Study First Received: December 17, 2009
Last Updated: March 20, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pseudomonas Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
 Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections
Colistin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013