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

Non-Cystic Fibrosis Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081963
• Other study ID #: NCFB-AMK-01
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Fibrosis
• Non-Cystic Fibrosis Bronchiectasis

Intervention

Drug:
• Amikacin
Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.
• Normal saline
Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial Clearance Rate of Sputum	The bacterial eradication rate of the sputum was calculated by the number of P. aeruginosa-eradicated cases according to sputum culture testing result. Sputum samples were collected in the morning after toothbrushing and gargling, before the patients used any medicine. Eligible sputum samples were defined as having =25 white blood cells/highpower field and =10 epithelial cells/high-power field; the samples were sent for testing within 60 min. Sputum samples were collected again after 14 days. If the second sputum culture test showed a negative result after the first one had been positive, it was defined as eradicated.	after 14 days
Secondary	Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment		after 14 days
Secondary	Sputum Property Score After 14 Days of Treatment	The sputum properties were graded from 1 to 4, with 1 being assigned to transparent mucous sputum, 2 to yellow purulent sputum, 3 to green purulent sputum, and 4 to black green purulent sputum. Higher scores mean a worse outcome.	after 14 days
Secondary	Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment		after 14 days
Secondary	Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment		after 14 days