Bronchiectasis
Conditions
Interventions
1. Nebulization of 99mTc-DTPA and tobramycin 125 mg without carbon dioxide enriched air with an Aero Eclipse II ® nebulizer
2. Nebulization of 99mTc-DTPA and tobramycin 125 mg with carbon dioxide enriched ambient air with an Aero Eclipse II ® nebulizer
3. Nebulization of 99mTc-DTPA and tobramycin 300 mg without carbon dioxide enriched air with a Pari LC Plus ® nebulizer.
The interventions have a duration of 3 days with at least 72 hours in between
Sponsors
VU University medical center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Bronchiectasis; 2. Antibiotic inhalation therapy.
Exclusion criteria
Exclusion criteria: 1. Age 50 mmHg, WHO Global Initiative for Chronic Obstructive Lung Disease 2006); 3. Renal insufficiency defined as renal creatinine clearance of < 30 ml/minute; 4. Neuromuscular diseases; 5. Impaired hearing; 6. Pregnant or breastfeeding; 7. Bronchiectasis exacerbation during last 4 weeks; 8. History of panic attacks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase A study: Feasibility study (SPECT/CT). Mean clearance rate (and range) of 99mTc-DTPA. Phase B study: 1. Total and peripheral deposition of inhaled tobramycin (with and without carbon dioxide and with two different nebulizers); 2. Pharmacokinetics: C max (peak concentration), AUC (0-8 hours), T max (time to reach maximum concentration), T1/2 (half life). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Peak expiratory flow; 2. Respiratory parameters; 3. Borg score (subjective sensation of dyspnoea). | — |
Contacts
Public ContactT. Paff
Postbus 7057
Outcome results
None listed