Trials / Completed
CompletedNCT02657473
Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis
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.
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Medical Center Alkmaar · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tobramycin inhalation solution | |
| DRUG | Saline 0.9% inhalation solution |
Timeline
- Start date
- 2016-08-13
- Primary completion
- 2019-12-13
- Completion
- 2019-12-13
- First posted
- 2016-01-15
- Last updated
- 2019-12-17
Locations
6 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02657473. Inclusion in this directory is not an endorsement.