Clinical trial NCT02081963: Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
Official title: A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Cystic Fibrosis Bronchiectasis
Keywords: Nebulized amikacin;
Non-Cystic Fibrosis Bronchiectasis;
Bacterial clearance rate of sputum；
Acute exacerbation.
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Bacterial Clearance Rate of Sputum
timeFrame: after 14 days
Secondary outcomes:
measure: Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment
timeFrame: after 14 days
measure: Sputum Property Score After 14 Days of Treatment
timeFrame: after 14 days
measure: Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment
timeFrame: after 14 days
measure: Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment
timeFrame: after 14 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Director
name: Yu Li, Professor
role: STUDY_DIRECTOR
References: