A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bronchiectasis

Intervention / Treatment
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* Drug: Tobramycin
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female study subjects ≥18 years of age and ≤80 years of age Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis Confirmation of infection with P. aeruginosa at screening Are sensitive to Tobramycin Acute exacerbation of bronchiectasis - Exclusion Criteria: Bronchiectasis due to special causes. Smokers. Are associated with bronchial asthma. Have any serious or active medical or psychiatric illness. Are not tolerant to nebulised tobramycin FEV1.0 reduces ≥ 15% after inhaling tobramycin. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nebulised Tobramycin<br>Nebulised Tobramycin | Drug: Tobramycin<br>* Nebulised 80mg twice daily<br>|
| Placebo Comparator: Nebulised 0.9% Saline<br>Nebulised 0.9% Saline | Drug: Saline<br>* Nebulised 5mls 0.9% Saline twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate change in density of Pseudomonas aeruginosa in sputum |  | days 1,7,14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate chang in the amount of sputum |  | days 1,7,14 | 
| To evaluate chang in patients' cough severity |  | days 1,7,14 | 
| To evaluate change in pulmonary function |  | days 1,7,14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiectasis, Tobramycin, nebulised