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

NCT02081963 | Completed Phase 4 Results

• 1 other identifier: NCFB-AMK-01
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Cystic Fibrosis Bronchiectasis

Keywords

Nebulized amikacin;; Non-Cystic Fibrosis Bronchiectasis;; Bacterial clearance rate of sputum；; Acute exacerbation.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment

  after 14 days

• Sputum Property Score After 14 Days of Treatment

  after 14 days

• Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment

  after 14 days

• Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment

  after 14 days

Study Arms (2)

Nebulized amikacin

EXPERIMENTAL

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

Drug: Amikacin

Nebulized normal saline

OTHER

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

Drug: Normal saline

Interventions

Amikacin DRUG

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

Nebulized amikacin

Normal saline DRUG

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

Nebulized normal saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Interventions

Amikacin; Saline Solution

Intervention Hierarchy (Ancestors)

Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr.Yu Li
• Organization: Department of Respiratory Medicine, Qilu Hospital of Shandong University

qlliyu@163.com

13791122770

Study Officials

• Yu Li, Professor

  Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant director

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 7, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 24, 2019
• Results First Posted: April 16, 2019

Record last verified: 2015-11

Locations

CN (1)