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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystic Fibrosis, Pseudomonas Aeruginosa

Intervention / Treatment
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* Drug: Tobramycin (Gernebcin®)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways