Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-centered, randomized, controlled study to assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.

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

Details

• Lead Sponsor: Qilu Hospital; Qilu Hospital of Shandong University
• Treatments: Amikacin

Criteria

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 Pseudomonas aeruginosa at screening;

• Are sensitive to amikacin;

• 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;

• Be allergic to amikacin or not tolerant to nebulised amikacin(FEV1 reduces ≥15% after inhaling amikacin.