NCT01677403

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	Tobramycin	Nebulised 80mg twice daily
DRUG	Saline	Nebulised 5mls 0.9% Saline twice daily

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-09-03
• Last updated: 2012-12-05

Locations

1 site across 1 country: China