Bronchiectasis Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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