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

December 13, 2019 updated by: W.G.Boersma, Medical Center Alkmaar

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.

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.

Study Overview

Detailed Description

See uploaded study protocol

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amsterdam, Netherlands
        • VU Medical Center
      • Heerlen, Netherlands
        • Zuyderland Medisch Centrum
      • Hoofddorp, Netherlands
        • Spaarne Gasthuis
      • Nijmegen, Netherlands
        • Canisius Ziekenhuis
      • Utrecht, Netherlands
        • UMCU
    • Noord-Holland
      • Alkmaar, Noord-Holland, Netherlands, 1815JD
        • North West Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TIS 300mg once daily
Tobramycin inhalation solution (TIS) 300mg once daily for at least 9 months and up to 12 months
Placebo Comparator: Placebo once daily
Saline 0.9% inhalation solution 300mg once daily for at least 9 months and up to 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of exacerbations
Time Frame: 13 months
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wim G. Boersma, Dr.MD, Medical Center Alkmaar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2016

Primary Completion (Actual)

December 13, 2019

Study Completion (Actual)

December 13, 2019

Study Registration Dates

First Submitted

January 13, 2016

First Submitted That Met QC Criteria

January 13, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Actual)

December 17, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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