Non-CF Bronchiectasis
Conditions
Brief summary
The purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS) once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint is a reduction of exacerbations of the disease during the treatment period. Next to this parameter the investigators expect to show a significant beneficial effect on lung function parameters, QoL, bacterial load of pathogens in sputum and tobramycin resistance.
Detailed description
See uploaded study protocol
Interventions
DRUGSaline 0.9% inhalation solution
Sponsors
Medical Center Alkmaar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
. In present study the value of maintenance TIS will be investigated in patients with non-CF bronchiectasis colonized by different bacterial species sensitive for tobramycin. Objective: The primary outcome of the study is a 50% reduction in exacerbation rate in patients using maintenance TIS (OD). Secondary outcome parameters are lung function (FEV1, FVC), QoL (QOL-B), LTRI-VAS, Leicester cough score, bacterial load in sputum and tobramycin resistant pathogens. Study design: A randomised, double blind placebo controlled, multicenter study. Study population: Patients aged ≥ 18-year-old with confirmed bronchiectasis by (HR)CT and at least two exacerbations during previous 12 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 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 at screening visit sensitive to tobramycin 8. Tolerance of inhaled tobramycin
Exclusion criteria
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. Change in physiotherapy technique or schedule within 1 month prior to the start of the study 8. Severe immunosuppression or active malignancy 9. Active tuberculosis 10. Chronic renal insufficiency (eGFR \< 30 ml/min), use of loop diuretics 11. Have received an investigational drug or device within 1 month prior to the start of the study 12. Serious or active medical or psychiatric illness 13. Pregnancy and child bearing 14. History of poor cooperation or non-compliance 15. Unable to use nebulizers 16. Allergic for tobramycin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of exacerbations | 13 months |
Countries
Netherlands
Outcome results
None listed