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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong University
• Treatments: Tobramycin

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. -