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

NCT00774072 | Completed Phase 2 DMC

• 1 other identifier: tobra nasal CF pilot
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis; Pseudomonas Aeruginosa

Keywords

subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways

Outcome Measures

Primary Outcomes (1)

• Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid

  day -1, 1, 29, 30, 59, 60

Secondary Outcomes (2)

• Measure of serum levels of tobramycin

  day 1, 30 and 60

• Tolerability

  day 1, 30 and 60

Study Arms (2)

Tobramycin 80 mg

ACTIVE COMPARATOR

applied once daily via Pari Sinus nebulizer

Drug: Tobramycin (Gernebcin®)

isotonic saline

PLACEBO COMPARATOR

applied once daily via Pari Sinus nebulizer

Drug: Tobramycin (Gernebcin®)

Interventions

Tobramycin (Gernebcin®) DRUG

1 ml / day in each nostril

Tobramycin 80 mg; isotonic saline

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• University of Jena: lead

Study Sites (2)

Universitäts-Kinderklinik

Tübingen, Baden-Würtemberg, 72076, Germany

Location

Mukoviszidosezentrum der Friedrich-Schiller-Universität

Jena, Thuringia, 07745, Germany

Location

Related Publications (3)

• Mainz JG, Arnold C. Authors' reply. Drug Des Devel Ther. 2014;8:1136-7. No abstract available.

  PMID: 25199217 BACKGROUND

• 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.

  PMID: 22045752 BACKGROUND

• 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.

  PMID: 24596456 RESULT

MeSH Terms

Conditions

Cystic Fibrosis; Pseudomonas Infections

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Jochen Mainz, M.D.

  University of Jena, Children's hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, CF Center

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

DE (2)