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
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.
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Mukoviszidosezentrum der Friedrich-Schiller-Universität | Jena | Thüringen |
Germany | Universitäts-Kinderklinik | Tübingen | Baden-Würtemberg |
Lead Sponsor | Collaborator |
---|---|
University of Jena |
Germany,
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
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 |
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