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

NCT ID: NCT02081963

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-12-31

Brief 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.

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.

Conditions

Non-Cystic Fibrosis Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nebulized amikacin

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

Group Type: EXPERIMENTAL

Amikacin

Intervention Type: DRUG

Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.

Nebulized normal saline

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

Group Type: OTHER

Normal saline

Intervention Type: DRUG

Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.

Interventions

Amikacin

Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.

Intervention Type: DRUG

Normal saline

Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Qian Qi

assistant director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu Li, Professor

Role: STUDY_DIRECTOR

Director

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

NCFB-AMK-01

Identifier Type: -

Identifier Source: org_study_id