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

• Sponsor: University of Jena (Other)
• Overall Status: Completed
• CT.gov ID: NCT01035853
• Collaborator: (none)
• Enrollment: 10
• Locations: 3
• Duration (Months): 28
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis; Pseudomonas Aeruginosa	Drug: Colistin	Phase 2

Study Design

• Study Type: Interventional
• 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: Dec 1, 2009
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Apr 1, 2012

Outcome Measures

Primary Outcome Measures

1. Decrease of Pseudomonas aeruginosa in Nasal lavage fluid [60 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitäts-Kinderklinik	Tübingen	Baden-Würtemberg	Germany
2	Mukoviszidosezentrum der Friedrich-Schiller-Universität	Jena	Thüringen	Germany	07743
3	CF-Zentrum	Hamburg		Germany	22763

Sponsors and Collaborators

• University of Jena

Investigators

• Study Chair: Jochen Mainz, M.D., University of Jena, Children's hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PD Dr. Jochen G. Mainz, PD Dr., University of Jena
• ClinicalTrials.gov Identifier: NCT01035853
• Other Study ID Numbers: colistin nasal cf pilot
• First Posted: Dec 21, 2009
• Last Update Posted: Mar 21, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Pseudomonas Infections; Cystic Fibrosis; Fibrosis; Colistin

Study Results

No Results Posted as of Mar 21, 2013