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Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis

NCT06093191 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 371

Last updated 2026-04-17

No results posted yet for this study

Summary

People with bronchiectasis are prone to Pseudomonas aeruginosa (PA) infections, which can become chronic and lead to increased death rates and disease severity. Studies from cystic fibrosis suggest that eradication therapy aimed at PA can successfully transition patients to a culture-negative status, providing long-term benefits. Current guidelines for managing bronchiectasis in adults recommend eradicating PA when it is first or newly isolated; however, there is a lack of randomized controlled trials supporting such recommendations. The researchers hypothesize that both oral ciprofloxacin combined with tobramycin inhalation solution and tobramycin inhalation solution alone are superior to no eradication (inhaled saline) in terms of the eradication rate of PA (with eradication defined as negative sputum culture results on two consecutive occasions separated by an interval of 12 weeks or more after the first drug administration).

Conditions

  • Bronchiectasis Adult
  • Pseudomonas Aeruginosa Infection

Interventions

DRUG

Tobramycin Inhalant Product

Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.

DRUG

Ciprofloxacin 750 MG

Oral ciprofloxacin 750mg twice daily will be prescribed for 2 weeks.

DRUG

Oral ciprofloxacin placebo

Oral ciprofloxacin placebo twice daily will be prescribed for 2 weeks.

DRUG

Natural saline inhalation

Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.

Sponsors & Collaborators

  • Jin-Fu Xu

    lead OTHER

Principal Investigators

  • Jin-Fu Xu, MD, PhD · Tongji Hospital, School of Medicine, Tongji University; Shanghai Pulmonary Hospital, School of Medicine, Tongji University; Huadong Hospital, School of Medicine, Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2025-10-28
Completion
2025-11-15

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 NCT06093191 on ClinicalTrials.gov