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

Phase 4

• Conditions: Bronchiectasis
• Interventions: Drug: Tobramycin; Drug: Saline

• Registration Number: NCT01677403
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-26
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-09-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-05
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 -

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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. -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulised Tobramycin	Tobramycin	Nebulised Tobramycin
Nebulised 0.9% Saline	Saline	Nebulised 0.9% Saline

Primary Outcome Measures

Name	Time	Method
To evaluate change in density of Pseudomonas aeruginosa in sputum	days 1,7,14

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shandong University; 🇨🇳 Jinan, Shandong, China