Pharmacokinetic evaluation and tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis
Phase 2
Completed
- Conditions
- airway bulges1000401810024970
- Registration Number
- NL-OMON39733
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
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 ciclosporin, cisplatin, amfotericin B, cephalosporins, polymyxins, vancomycin and NSAIDs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The following pharmacokinetic parameters will be calculated:<br /><br>actual dose (dose minus remainder in inhaler after inhalation)<br /><br>AUC0-12 (area under the curve from 0 -12 h)<br /><br>Cmax (maximum plasma concentration)<br /><br>Tmax (time to maximum plasma concentration)<br /><br>Ka (absorption rate constant)<br /><br>T1/2 el (terminal elimination half-life)<br /><br>CL/F (clearance following pulmonary administration (F= bioavailability))<br /><br><br /><br>The local tolerability will be tested by lung function measurement and<br /><br>spontaneous reporting of and questioning for adverse events. Both need to have<br /><br>a positive result.</p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>