A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis
|ClinicalTrials.gov Identifier: NCT01677403|
Recruitment Status : Unknown
Verified December 2012 by Qi Qian, Shandong University.
Recruitment status was: Recruiting
First Posted : September 3, 2012
Last Update Posted : December 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis||Drug: Tobramycin Drug: Saline||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
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
- To evaluate change in density of Pseudomonas aeruginosa in sputum [ Time Frame: days 1,7,14 ]
- To evaluate chang in the amount of sputum [ Time Frame: days 1,7,14 ]
- To evaluate chang in patients' cough severity [ Time Frame: days 1,7,14 ]
- To evaluate change in pulmonary function [ Time Frame: days 1,7,14 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677403
|Jinan, Shandong, China, 250100|