Pharmacokinetic evaluation and local tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis
- Conditions
- BronchiectasisLung infectionsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-004437-16-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
•Age 18 years or older
•Obtained informed consent
•Patients having bronchiectasis (confirmed with HR-CT of the chest)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
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 ciclosporin, cisplatin, amfotericin B, cephalosporins, polymyxins, vancomycin and NSAIDs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the pharmacokinetics and the local tolerabilityof dry powder tobramycin at different dosages in patients with bronchiectasis;Secondary Objective: not applicable;Primary end point(s): The following pharmacokinetic parameters will be calculated:<br>•Actual dose (dose minus remainder in inhaler after inhalation)<br>•AUC0-12 (area under the curve from 0 -12 h)<br>•Cmax (maximum plasma concentration)<br>•Tmax (time to maximum plasma concentration)<br>•Ka absorption rate constant<br>•T 1/2 el terminal elimination half-life<br>•CL/Fclearance following pulmonary administration (F= bioavailability)<br><br><br>Local tolerability of the inhalation of dry powder tobramycin. Both points need to have a positive result. <br>•Drop of FEV1 of >10% (lung function measurement)<br>•Adverse events <br>;Timepoint(s) of evaluation of this end point: within four weeks after the last test dose<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable<br>