ong-term inhaled nebulized tobramycin in patients with non-cystic fibrosis bronchiectasis. A randomized placebo controlled trial. The BATTLE study Bronchiectasis And Tobramycin SoluTion InhaLation ThErapy.
- Conditions
- bronchiectasis10006436
- Registration Number
- NL-OMON47248
- Lead Sponsor
- Medisch Centrum Alkmaar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 58
1. Age >= 18 years
2. The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum
3. Confirmed non-CF bronchiectasis by (HR)CT
4. Documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics and/or prednisolone within 12 months before inclusion.
5. No course of antibiotics or maintenance antibiotics (except for macrolides) 1 month prior to the start of the study.
6. Minimal one documented sputum or BAL-fluid culture with gram-negative bacteria or S.aureus within 12 months.
7. Growth of protocol defined pathogens in sputum sensitive to tobramycin at screening visit
1. Any exacerbation within the month prior to the start of the study
2. Diagnosis of cystic fibrosis
3. Active allergic bronchopulmonary aspergillosis (ABPA)
4. Any oral, IV or inhaled antibiotics (except for macrolides) within 1 month prior to the start of the study
5. Any IV or IM corticosteroids or change in oral corticosteroids (> 10 mg) within 1 month prior to the start of the study
6. Any change/start treatment regimens macrolides, hypertonic saline, inhaled mannitol or other mucolytics, corticosteroids within 1 month prior to the start of the study
7. Severe immunosuppression or active malignancy
8. Active tuberculosis
9. Chronic renal insufficiency (eGFR < 30 ml/min)
10. Have received an investigational drug or device within 1 month prior to the start of the study
11. Serious or active medical or psychiatric illness
12. Pregnancy and child bearing
13. History of poor cooperation or non-compliance
14. Unable to use nebulizers
15. Allergic for tobramycin or NaCl 0.9%
16. Use of diuretics, urea or mannitol
17. Demonstrated heraring impairment, balance disorders or neuromuscular disorders
18. Serious active haemoptysis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is a reduction of exacerbations that patients suffer<br /><br>during the treatment period. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Next to this parameter we expect to show a significant beneficial effect on<br /><br>lung function parameters, QoL, bacterial load of pathogens in sputum and<br /><br>tobramycin resistance.</p><br>