Overview

This trial is active, not recruiting.

Condition non-cystic fibrosis bronchiectasis
Treatments amikacin, normal saline
Phase phase 4
Sponsor Qilu Hospital
Start date March 2014
End date December 2015
Trial size 150 participants
Trial identifier NCT02081963, NCFB-AMK-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.
amikacin
Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.
(Other)
Participants received nebulized normal saline BID 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.

Primary Outcomes

Measure
Bacterial clearance rate of sputum
time frame: up to day 14

Secondary Outcomes

Measure
Volume of sputum for 24 hours
time frame: day 1, 7, 14
The nature of sputum
time frame: day 1, 7, 14
The content of bacterial in sputum
time frame: day 1, 7, 14
Acute exacerbations
time frame: 3 months
Change in forced expiratory volume in one second (FEV1) (Percent of Predicted for Age)
time frame: day 1, 14
Forced expiratory volume in one second (FEV1) (L)
time frame: day 1, 14
Forced vital capacity (FVC) (L)
time frame: day 1, 14
Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory data
time frame: day 7, 14

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Qilu Hospital.