A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis

A Randomized,Controlled Study to Evaluate the Efficacy,Indications,Adverse Reactions and Resistance of Combined Administration of Nebulized Tobramycin Compared With Systemic Administration Alone in Patients With Bronchiectasis

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01677403

Enrollment

120

Registered

2012-09-03

Start date

2012-08-31

Completion date

2014-12-31

Last updated

2012-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis

Keywords

Bronchiectasis, Tobramycin, nebulised

Brief summary

This is a study to evaluate the efficacy,indications,adverse reactions and resistance of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.

Detailed description

Bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. The origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response is typical of the disease. The chronic nature of the infection and the associated considerable morbidity provides the rationale for using aerosolized antibiotics for the treatment of bronchiectasis patients. This is a study of safety and efficacy of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis. Study subjects will be randomized to receive either study drug or placebo by inhalation via a nebulizer. Each subject will complete 14 days of daily dosing. Clinical laboratory parameters,clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and efficacy of nebulized tobramycin.

Interventions

DRUGTobramycin

Nebulised 80mg twice daily

DRUGSaline

Nebulised 5mls 0.9% Saline twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Male or female study subjects ≥18 years of age and ≤80 years of age 2. Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis 3. Confirmation of infection with P. aeruginosa at screening 4. Are sensitive to Tobramycin 5. Acute exacerbation of bronchiectasis -

Exclusion criteria

1. Bronchiectasis due to special causes. 2. Smokers. 3. Are associated with bronchial asthma. 4. Have any serious or active medical or psychiatric illness. 5. Are not tolerant to nebulised tobramycin 6. FEV1.0 reduces ≥ 15% after inhaling tobramycin. -

Design outcomes

Primary

Measure	Time frame
To evaluate change in density of Pseudomonas aeruginosa in sputum	days 1,7,14

Secondary

Measure	Time frame
To evaluate chang in the amount of sputum	days 1,7,14
To evaluate chang in patients' cough severity	days 1,7,14
To evaluate change in pulmonary function	days 1,7,14

Countries

China

Contacts

Primary ContactQi

xiaokangqlh@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026