Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

Non-CF Bronchiectasis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657473
• Other study ID #: 54939
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 13, 2016
• Est. completion date: December 13, 2019

Study information

• Verified date: December 2019
• Source: Medical Center Alkmaar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See uploaded study protocol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 13, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Non-CF Bronchiectasis

Intervention

Drug:
• tobramycin inhalation solution

• Saline 0.9% inhalation solution

Locations

Country	Name	City	State
Netherlands	North West Clinics	Alkmaar	Noord-Holland
Netherlands	VU Medical Center	Amsterdam
Netherlands	Zuyderland Medisch Centrum	Heerlen
Netherlands	Spaarne Gasthuis	Hoofddorp
Netherlands	Canisius Ziekenhuis	Nijmegen
Netherlands	UMCU	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Medical Center Alkmaar

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of exacerbations		13 months