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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035853
• Other study ID #: colistin nasal cf pilot
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2009
• Last updated: March 20, 2013
• Start date: December 2009
• Est. completion date: April 2012

Study information

• Verified date: March 2013
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Intervention

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

Locations

Country	Name	City	State
Germany	CF-Zentrum	Hamburg
Germany	Mukoviszidosezentrum der Friedrich-Schiller-Universität	Jena	Thüringen
Germany	Universitäts-Kinderklinik	Tübingen	Baden-Würtemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of Pseudomonas aeruginosa in Nasal lavage fluid		60 days	No