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

Shandong University

Status and phase: Completed; Phase 4

Conditions: Non-Cystic Fibrosis Bronchiectasis

Treatments: Drug: Normal saline; Drug: Amikacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02081963

NCFB-AMK-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

Nebulized amikacin

Experimental group

Description:

Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.

Treatment:

Drug: Amikacin

Nebulized normal saline

Other group

Description:

Participants received nebulized normal saline BID for 14 days in combination with standard treatment.

Treatment:

Drug: Normal saline