Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02081963
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : April 16, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Qian Qi, Qilu Hospital of Shandong University

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.

Condition or disease Intervention/treatment Phase
Non-Cystic Fibrosis Bronchiectasis Drug: Amikacin Drug: Normal saline Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
Actual Study Start Date : March 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nebulized amikacin
Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.
Drug: Amikacin
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.
Drug: Normal saline
Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.




Primary Outcome Measures :
  1. Bacterial Clearance Rate of Sputum [ Time Frame: after 14 days ]
    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.


Secondary Outcome Measures :
  1. Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment [ Time Frame: after 14 days ]
  2. Sputum Property Score After 14 Days of Treatment [ Time Frame: after 14 days ]
    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.

  3. Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment [ Time Frame: after 14 days ]
  4. Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment [ Time Frame: after 14 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081963


Locations
Layout table for location information
China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Qilu Hospital of Shandong University
Investigators
Layout table for investigator information
Study Director: Yu Li, Professor Director

Layout table for additonal information
Responsible Party: Qian Qi, assistant director, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT02081963    
Other Study ID Numbers: NCFB-AMK-01
First Posted: March 7, 2014    Key Record Dates
Results First Posted: April 16, 2019
Last Update Posted: April 24, 2019
Last Verified: November 2015
Keywords provided by Qian Qi, Qilu Hospital of Shandong University:
Nebulized amikacin;
Non-Cystic Fibrosis Bronchiectasis;
Bacterial clearance rate of sputum;
Acute exacerbation.
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchiectasis
Fibrosis
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents