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

• 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: Qilu Hospital of Shandong University
• Information provided by (Responsible Party): Qian Qi, Qilu Hospital of Shandong University

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

China, Shandong

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

Sponsors and Collaborators

Qilu Hospital of Shandong University

Investigators

• Study Director: Yu Li, Professor; Director

More 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
• 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:

Bronchiectasis; Fibrosis; Pathologic Processes; Bronchial Diseases; Respiratory Tract Diseases; Amikacin; Anti-Bacterial Agents; Anti-Infective Agents