Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

See uploaded study protocol

Inclusion criteria

• Age ≥ 18 years
• The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum
• Confirmed non-CF bronchiectasis by (HR)CT
• Documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics within 12 months before inclusion.
• No course of antibiotics or maintenance antibiotics (except for macrolides) 1 month prior to the start of the study.
• Minimal one documented sputum or BAL-fluid culture with gram-negative bacteria or S.aureus within 12 months.
• Growth of protocol defined pathogens in sputum at screening visit sensitive to tobramycin
• Tolerance of inhaled tobramycin

Exclusion criteria

• Any exacerbation within the month prior to the start of the study
• Diagnosis of cystic fibrosis
• Active allergic bronchopulmonary aspergillosis (ABPA)
• Any oral, IV or inhaled antibiotics (except for macrolides) within 1 month prior to the start of the study
• Any IV or IM corticosteroids or change in oral corticosteroids (> 10 mg) within 1 month prior to the start of the study
• Any change/start treatment regimens macrolides, hypertonic saline, inhaled mannitol or other mucolytics, corticosteroids within 1 month prior to the start of the study
• Change in physiotherapy technique or schedule within 1 month prior to the start of the study
• Severe immunosuppression or active malignancy
• Active tuberculosis
• Chronic renal insufficiency (eGFR < 30 ml/min), use of loop diuretics
• Have received an investigational drug or device within 1 month prior to the start of the study
• Serious or active medical or psychiatric illness
• Pregnancy and child bearing
• History of poor cooperation or non-compliance
• Unable to use nebulizers
• Allergic for tobramycin