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

Condition(s) targeted: Non-Cystic Fibrosis Bronchiectasis

Intervention: Amikacin (Drug); Normal saline (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Qilu Hospital

Official(s) and/or principal investigator(s):
Yu Li, Professor, Study Director, Affiliation: Director

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.

Official title: A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bacterial clearance rate of sputum

Secondary outcome:

Volume of sputum for 24 hours

The nature of sputum

The content of bacterial in sputum

Acute exacerbations

Change in forced expiratory volume in one second (FEV1) (Percent of Predicted for Age)

Forced expiratory volume in one second (FEV1) (L)

Forced vital capacity (FVC) (L)

Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory data

Detailed description: Objective: 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. Methods: Patients with acute exacerbation of non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive nebulized amikacin BID for 14 days in combination with standard treatment) or the control group (participants receive nebulized 0. 9% saline BID for 14 days in combination with standard treatment). The primary endpoint was bacterial clearance rate of sputum. Expected results: Compared with the control group, bacterial clearance rate of sputum of the observer Group will increase significantly.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Qilu Hospital of Shandong University, Jinan, Shandong 250012, China

Starting date: March 2014
Last updated: April 13, 2015