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

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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa
• Intervention / Treatment: Drug: Tobramycin (Gernebcin®)

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Baden-Würtemberg
    • Tübingen, Baden-Würtemberg, Germany, 72076
      • Universitäts-Kinderklinik
  • Thüringen
    • Jena, Thüringen, Germany, 07745
      • Mukoviszidosezentrum der Friedrich-Schiller-Universität

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tobramycin 80 mg; applied once daily via Pari Sinus nebulizer	Drug: Tobramycin (Gernebcin®); 1 ml / day in each nostril
Placebo Comparator: isotonic saline; applied once daily via Pari Sinus nebulizer	Drug: Tobramycin (Gernebcin®); 1 ml / day in each nostril

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid	day -1, 1, 29, 30, 59, 60

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure of serum levels of tobramycin	day 1, 30 and 60
Tolerability	day 1, 30 and 60

Collaborators and Investigators

• Sponsor: University of Jena

Publications and helpful links

General Publications

• Mainz JG, Arnold C. Authors' reply. Drug Des Devel Ther. 2014;8:1136-7. No abstract available.
• 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. doi: 10.1164/ajrccm.184.9.1089. No abstract available.
• Mainz JG, Schadlich K, Schien C, Michl R, Schelhorn-Neise P, Koitschev A, Koitschev C, Keller PM, Riethmuller J, Wiedemann B, Beck JF. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study. Drug Des Devel Ther. 2014 Feb 10;8:209-17. doi: 10.2147/DDDT.S54064. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: October 16, 2008
• First Submitted That Met QC Criteria: October 16, 2008
• First Posted (Estimate): October 17, 2008

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pancreatic Diseases; Fibrosis; Cystic Fibrosis; Pseudomonas Infections; Anti-Infective Agents; Anti-Bacterial Agents; Tobramycin
• Other Study ID Numbers: tobra nasal CF pilot