Clinical trial NCT00774072: Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
Official title: Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Pseudomonas Aeruginosa
Keywords: subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2008-10-17
Enrollment: 9
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid
timeFrame: day -1, 1, 29, 30, 59, 60
Secondary outcomes:
measure: Measure of serum levels of tobramycin
timeFrame: day 1, 30 and 60
measure: Tolerability
timeFrame: day 1, 30 and 60
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universitäts-Kinderklinik
state: Baden-Würtemberg
city: Jena
country: Germany
facility: Mukoviszidosezentrum der Friedrich-Schiller-Universität
state: Thüringen
Study officials:
affiliation: University of Jena, Children's hospital
name: Jochen Mainz, M.D.
role: STUDY_CHAIR
References:
citation: Mainz JG, Arnold C. Authors' reply. Drug Des Devel Ther. 2014;8:1136-7. No abstract available.
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. doi: 10.1164/ajrccm.184.9.1089. No abstract available.
citation: 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.