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Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis

NCT02657473 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-12-17

No results posted yet for this study

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.

Conditions

  • Non-CF Bronchiectasis

Interventions

DRUG

tobramycin inhalation solution

DRUG

Saline 0.9% inhalation solution

Sponsors & Collaborators

  • Medical Center Alkmaar

    lead OTHER

Principal Investigators

  • Wim G. Boersma, Dr.MD · Medical Center Alkmaar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-13
Primary Completion
2019-12-13
Completion
2019-12-13

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02657473 on ClinicalTrials.gov