Effects of long term ToBrAmycin InhalaTion SoluTion (TIS) once daiLy on Exacerbation rate in patients with non-cystic fibrosis bronchiectasis. A double blind, randomized, placebo and TIS twice daily (open label) controlled trial. The BATTLE study.

oordwest Ziekenhuisgroep0 个研究点开始时间: 2016年5月17日最近更新: 2016年8月22日

适应症

试验速览

暂无简介。

•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

•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

发起方

oordwest Ziekenhuisgroep