Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization

Cystic Fibrosis Clinical Trial

Official title:

Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774072
• Other study ID #: tobra nasal CF pilot
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2008
• Last updated: December 3, 2014
• Start date: October 2008
• Est. completion date: November 2010

Study information

• Verified date: December 2014
• 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 Gernebcin® is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 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 is older than 7 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: FEV1 < 30% and / or SaO2 < 93% without O2-substitution; need of O2-substitution

• subject had an ENT 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 aerug.

• 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

• if serum level of tobramycin is above 2 mg/l one hour after inhalation, subject has to withdraw the participation in the study.

• progressed renal insufficiency

• severe damage of the N. acusticus

• dizziness (potential damage of. N. vestibularis)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Intervention

Drug:
• Tobramycin (Gernebcin®)
1 ml / day in each nostril

Locations

Country	Name	City	State
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, 

References & Publications (3)

Mainz JG, Arnold C. Authors’ reply. Drug Des Devel Ther. 2014;8:1136-7. — View Citation

Mainz JG, Michl R, Pfister W, Beck JF. Cystic fibrosis upper airways primary colonization with Pseudomonas aeruginosa: eradicated by sinonasal antibiotic inhalation. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1089-90. — View Citation

Mainz JG, Schädlich K, Schien C, Michl R, Schelhorn-Neise P, Koitschev A, Koitschev C, Keller PM, Riethmüller J, Wiedemann B, Beck JF. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginos — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid		day -1, 1, 29, 30, 59, 60	No
Secondary	Measure of serum levels of tobramycin		day 1, 30 and 60	Yes
Secondary	Tolerability		day 1, 30 and 60	Yes