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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02657473
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : December 17, 2019
Information provided by (Responsible Party):
W.G.Boersma, Medical Center Alkmaar

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.

Condition or disease Intervention/treatment Phase
Non-CF Bronchiectasis Drug: tobramycin inhalation solution Drug: Saline 0.9% inhalation solution Phase 2 Phase 3

Detailed Description:
See uploaded study protocol

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : August 13, 2016
Actual Primary Completion Date : December 13, 2019
Actual Study Completion Date : December 13, 2019

Resource links provided by the National Library of Medicine

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
Drug: tobramycin inhalation solution
Placebo Comparator: Placebo once daily
Saline 0.9% inhalation solution 300mg once daily for at least 9 months and up to 12 months
Drug: Saline 0.9% inhalation solution

Primary Outcome Measures :
  1. Number of exacerbations [ Time Frame: 13 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02657473

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North West Clinics
Alkmaar, Noord-Holland, Netherlands, 1815JD
VU Medical Center
Amsterdam, Netherlands
Zuyderland Medisch Centrum
Heerlen, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Canisius Ziekenhuis
Nijmegen, Netherlands
Utrecht, Netherlands
Sponsors and Collaborators
Medical Center Alkmaar
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Principal Investigator: Wim G. Boersma, Dr.MD Medical Center Alkmaar
  Study Documents (Full-Text)

Documents provided by W.G.Boersma, Medical Center Alkmaar:

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Responsible Party: W.G.Boersma, Dr.MD., Medical Center Alkmaar Identifier: NCT02657473    
Other Study ID Numbers: 54939
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents