Brief Title
A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis
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
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
To evaluate change in density of Pseudomonas aeruginosa in sputum
Secondary Outcome
To evaluate chang in the amount of sputum
Condition
Bronchiectasis
Intervention
Tobramycin
Study Arms / Comparison Groups
Nebulised Tobramycin
Description: Nebulised Tobramycin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
120
Start Date
August 2012
Completion Date
December 2014
Primary Completion Date
December 2014
Eligibility Criteria
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. -
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
, , [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01677403
Organization ID
qlhqiqian
Secondary IDs
QL
Responsible Party
Principal Investigator
Study Sponsor
Shandong University
Study Sponsor
, ,
Verification Date
December 2012