Pharmacokinetic evaluation and tolerability of dry powder tobramycin via the Cyclops® in children with cystic fibrosis
Phase 2
Completed
- Conditions
- Cystic Fibrosis1000401810010613
- Registration Number
- NL-OMON50074
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
- Clinical diagnosis of CF and a positive sweat test or two CF-related mutations
- Age 6 - 18 years
- Ability to breathe through a mouthpiece and to use the Cyclops
- Ability to perform pulmonary function tests
- Written informed consent (child and parents)
Exclusion Criteria
- Acute exacerbation
- FEV1 < 60%
- Subjects with known or suspected renal, auditory, vestibular of neuromuscular
dysfunction, or with severe, active haemoptysis
- History of adverse events on previous tobramycin or other amino glycoside use
- History of adverse events on previous dry powder inhalation
- Concurrent use of cyclosporine, amphotericin B, cephalosporins, polymyxins,
vancomycin and NSAID*s
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The following pharmacokinetic parameters will be calculated: AUC0 till 8-12<br /><br>(area under the curve from 0 till 8-12 h)</p><br>
- Secondary Outcome Measures
Name Time Method <p>The following pharmacokinetic parameters will be calculated: actual dose (dose<br /><br>minus remainder in inhaler after inhalation), Cmax (maximum plasma<br /><br>concentration), Tmax (time to maximum plasma concentration), Ka (absorption<br /><br>rate constant), T1/2 el (terminal elimination half-life), CL/F (clearance<br /><br>following pulmonary administration (F= bioavailability)). Local tolerability of<br /><br>DP Tobramycin is determined by scoring adverse events, specifically coughing,<br /><br>and lung function measurement. </p><br>