Clinical trial NCT02657473: Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis
Official title: Long-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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non-CF Bronchiectasis
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Eligibility 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 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

Primary outcomes:
measure: Number of exacerbations
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: North West Clinics
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Nijmegen
country: Netherlands
facility: Canisius Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMCU
Study officials:
affiliation: Medical Center Alkmaar
name: Wim G. Boersma, Dr.MD
role: PRINCIPAL_INVESTIGATOR
References: