Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02657473
• Date of registration: 13/01/2016
• Prospective Registration: Yes
• Primary sponsor: Medical Center Alkmaar
• Public title: Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis BATTLE
• Scientific 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.
• Date of first enrolment: August 13, 2016
• Target sample size: 58
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02657473
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Netherlands

Contacts

• Name: Wim G. Boersma, Dr.MD
• Affiliation: Medical Center Alkmaar

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-CF Bronchiectasis

Intervention(s)

Drug: tobramycin inhalation solution

Drug: Saline 0.9% inhalation solution

Primary Outcome(s)

Number of exacerbations [Time Frame: 13 months]

Secondary ID(s)

54939

Source(s) of Monetary Support

Please refer to primary and secondary sponsors