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Tobramycin in Bronchiectasis Colonized With Pseudmonas Aeruginosa

NCT03715322 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2019-08-02

No results posted yet for this study

Summary

This is a phase 3 study. Patients will be enrolled from 14 medical centers in mainland China. Eligible patients will be randomly allocated to treatment group (tobramycin nebulization, 300mg bid) and control group (natural saline nebulization, 5ml bid). A total of two 28-day on-and-off cycles will be scheduled. Both tobramycin solution and natural saline and the nebulizer will be solely provided by the sponsor.

Conditions

  • Bronchiectasis Adult
  • Pseudomonas Infections

Interventions

DRUG

Tobramycin Inhalant Product

Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of two 28-day on-and-off cycles will be scheduled.

OTHER

usual care

ambroxool (30mg thrice daily), or N-acetylcysteine (0.2g thrice daily) plus chest physiotherapy (5 min, once daily)

DRUG

Natural saline inhalation

Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of two 28-day on-and-off cycles will be scheduled.

Sponsors & Collaborators

  • Guangzhou Institute of Respiratory Disease

    lead OTHER

Principal Investigators

  • Nan-shan Zhong, MD · The First Affiliated Hospital of Guangzhou Medical University

  • Wei-jie Guan, PhD · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-26
Primary Completion
2021-04-30
Completion
2021-06-30

Countries

  • China

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 NCT03715322 on ClinicalTrials.gov