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Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis (BATTLE)

Primary Purpose

Non-CF Bronchiectasis

Status

Completed

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

tobramycin inhalation solution

Saline 0.9% inhalation solution

About this trial

This is an interventional treatment trial for Non-CF Bronchiectasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

North West Clinics
VU Medical Center
Zuyderland Medisch Centrum
Spaarne Gasthuis
Canisius Ziekenhuis
UMCU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TIS 300mg once daily

Placebo once daily

Arm Description

Tobramycin inhalation solution (TIS) 300mg once daily for at least 9 months and up to 12 months

Saline 0.9% inhalation solution 300mg once daily for at least 9 months and up to 12 months

Outcomes

Primary Outcome Measures

Number of exacerbations

Secondary Outcome Measures

Full Information

NCT ID

NCT02657473

First Posted

January 13, 2016

Last Updated

December 13, 2019

Sponsor

Medical Center Alkmaar

1. Study Identification

Unique Protocol Identification Number

NCT02657473

Brief Title

Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

Acronym

BATTLE

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

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

August 13, 2016 (Actual)

Primary Completion Date

December 13, 2019 (Actual)

Study Completion Date

December 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical Center Alkmaar

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-CF Bronchiectasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TIS 300mg once daily

Arm Type

Active Comparator

Arm Description

Tobramycin inhalation solution (TIS) 300mg once daily for at least 9 months and up to 12 months

Arm Title

Placebo once daily

Arm Type

Placebo Comparator

Arm Description

Saline 0.9% inhalation solution 300mg once daily for at least 9 months and up to 12 months

Intervention Type

Drug

Intervention Name(s)

tobramycin inhalation solution

Intervention Type

Drug

Intervention Name(s)

Saline 0.9% inhalation solution

Primary Outcome Measure Information:

Title

Number of exacerbations

Time Frame

13 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wim G. Boersma, Dr.MD

Organizational Affiliation

Medical Center Alkmaar

Official's Role

Principal Investigator

Facility Information:

Facility Name

North West Clinics

City

Alkmaar

State/Province

Noord-Holland

ZIP/Postal Code

1815JD

Country

Netherlands

Facility Name

VU Medical Center

City

Amsterdam

Country

Netherlands

Facility Name

Zuyderland Medisch Centrum

City

Heerlen

Country

Netherlands

Facility Name

Spaarne Gasthuis

City

Hoofddorp

Country

Netherlands

Facility Name

Canisius Ziekenhuis

City

Nijmegen

Country

Netherlands

Facility Name

UMCU

City

Utrecht

Country

Netherlands

12. IPD Sharing Statement

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Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

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