Patients with non-cystic fibrosis bronchiectasis MedDRA version: 19.0 Level: PT Classification code 10070295 Term: Infective exacerbation of bronchiectasis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Tobramycin Steri-Neb 300 mg/5 ml, inhalation solution
Pharmaceutical Form: Inhalation solution
Pharmaceutical form of the placebo: Inhalation solution
Route of administration of the placeb
Sponsors
Noordwest Ziekenhuisgroep
Eligibility
Sex/Gender
All
Inclusion criteria
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 (sensitive for tobramycin!!) within 12 months. 7. Growth of protocol defined pathogens in sputum at screening visit sensitive to tobramycin 8. Tolerance of inhaled tobramycin Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: 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) 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 |
|---|---|
| Timepoint(s) of evaluation of this end point: After informed consent patients have 3 monthly visits. During the visits patients have to deliver a sputum sample, fill in the QoL questionnaires and spirometry will be performed according the study schedule. Also a blood sample will be taken during a number of visits.;Main Objective: The primary objective of this study is to determine whether TIS once daily as compared to placebo may reduce the number of exacerbations in non-CF bronchiectasis and is equally effective as TIS BID open label 4 weeks on-off. ;Secondary Objective: The secondary objectives of this study are to assess the effect of TIS treatment on time to next exacerbation, FVC% predicted, FEV1% predicted, LTRI-VAS, Quality of Life-Bronchiectasis (QOL-B), Leicester cough score, bacterial load in sputum and tobramycin resistance for the initial pathogens.;Primary end point(s): 50% reduction in exacerbation rate in patients using TIS (OD or BID) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome parameters are lung function (FEV1, FVC), QoL (QOL-B), LTRI-VAS, Leicester cough score), bacterial load in sputum and tobramycin resistant pathogens.;Timepoint(s) of evaluation of this end point: After informed consent patients have 3 monthly visits. During the visits patients have to deliver a sputum sample, fill in the QoL questionnaires and spirometry will be performed according the study schedule. Also a blood sample will be taken during a number of visits. | — |
Countries
Netherlands
Contacts
Public ContactWG.Boersma
Noordwest ziekenhuisgroep
Outcome results
None listed