Effect Of CO2 On Nebulized Tobramycin.
- Conditions
- Bronchiectasis
- Registration Number
- NL-OMON25652
- Lead Sponsor
- VU University medical center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
1. Bronchiectasis;
2. Antibiotic inhalation therapy.
Exclusion Criteria
1. Age <21 years;
2. Chronic respiratory insufficiency defined according to the GOLD criteria (PaO2 < 60 mmHg or PaCO2 > 50 mmHg, WHO Global Initiative for Chronic Obstructive Lung Disease 2006);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase A study:<br /><br>Feasibility study (SPECT/CT). Mean clearance rate (and range) of 99mTc-DTPA.<br><br /><br /><br>Phase B study:<br /><br>1. Total and peripheral deposition of inhaled tobramycin (with and without carbon dioxide and with two different nebulizers);<br /><br>2. Pharmacokinetics: C max (peak concentration), AUC (0-8 hours), T max (time to reach maximum concentration), T1/2 (half life).
- Secondary Outcome Measures
Name Time Method 1. Peak expiratory flow;<br /><br>2. Respiratory parameters;<br /><br>3. Borg score (subjective sensation of dyspnoea).