A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- To evaluate change in density of Pseudomonas aeruginosa in sputum [ Time Frame: days 1,7,14 ] [ Designated as safety issue: No ]
- To evaluate chang in the amount of sputum [ Time Frame: days 1,7,14 ] [ Designated as safety issue: No ]
- To evaluate chang in patients' cough severity [ Time Frame: days 1,7,14 ] [ Designated as safety issue: No ]
- To evaluate change in pulmonary function [ Time Frame: days 1,7,14 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Nebulised Tobramycin
Nebulised 80mg twice daily
Placebo Comparator: Nebulised 0.9% Saline
Nebulised 0.9% Saline
Nebulised 5mls 0.9% Saline twice daily
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.
|Jinan, Shandong, China, 250100|