Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02035488
• Date of registration: 27/12/2013
• Prospective Registration: No
• Primary sponsor: University Medical Centre Groningen
• Public title: Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis
• Scientific title: Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis
• Date of first enrolment: October 2013
• Target sample size: 8
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02035488
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: Huib Kerstjens, MD, PhD
• Affiliation: University Medical Centre Groningen

Key inclusion & exclusion criteria

Inclusion criteria:

- Age 18 years or older

- Obtained informed consent

- Patients having bronchiectasis (confirmed with HR-CT of the chest)

Exclusion criteria:

- Pregnant or breast feeding

- Subjects with known or suspected renal, auditory, vestibular or neuromuscular
dysfunction, or with severe, active haemoptysis,

- History of adverse events on previous tobramycin or other aminoglycoside use

- No concurrent use of cyclosporin, cisplatin, amfotericin B, cephalosporins,
polymyxins, vancomycin and NSAIDs.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bronchiectasis

Intervention(s)

Drug: Tobramycin

Primary Outcome(s)

Decrease of FEV1 in percentage measured by spirometry [Time Frame: One day]

Absorption rate constant (Ka) of tobramycin [Time Frame: One day]

Area Under the plasma concentration versus time curve from 0 -12 hours (AUC0-12) of tobramycin •Area Under the plasma concentration versus time curve from 0 -12 hours (AUC0-12) of tobramycin [Time Frame: One day]

Clearance following pulmonary administration (CL/F) (F= bioavailability) of tobramycin [Time Frame: One day]

Maximum plasma concentration (Cmax ) of tobramycin [Time Frame: One day]

Number of Participants with Adverse Events [Time Frame: One day]

Time to maximum plasma concentration (Tmax) of tobramycin [Time Frame: One day]

Actual dose (dose minus remainder in inhaler after inhalation) of tobramycin [Time Frame: one day]

Terminal elimination half-life (T1/2 el ) of tobramycin [Time Frame: One day]

Secondary ID(s)

Tobra-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors