Non-Cystic Fibrosis Bronchiectasis
Conditions
Keywords
Nebulized amikacin;, Non-Cystic Fibrosis Bronchiectasis;, Bacterial clearance rate of sputum；, Acute exacerbation.
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.
Interventions
DRUGAmikacin
Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.
DRUGNormal saline
Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial Clearance Rate of Sputum | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | — |
Countries
China
Participant flow
Recruitment details
Eligible patients were screened and randomized at five tertiary hospitals in Shandong Province, China.
Pre-assignment details
A total of 178 patients were screened in this study, and 26 unquali-fied patients (14.6%) were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Nebulized Amikacin 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. | 79 |
| Nebulized Normal Saline 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. | 73 |
| Total | 152 |
Baseline characteristics
| Characteristic | Nebulized Normal Saline | Total | Nebulized Amikacin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 15 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 137 Participants | 70 Participants |
| Age, Continuous | 56.5 years STANDARD_DEVIATION 10.8 | 56.9 years STANDARD_DEVIATION 11.8 | 57.3 years STANDARD_DEVIATION 13 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment China | 69 participants | 143 participants | 74 participants |
| Sex: Female, Male Female | 37 Participants | 83 Participants | 46 Participants |
| Sex: Female, Male Male | 32 Participants | 60 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 79 | 1 / 73 |
| other Total, other adverse events | 1 / 79 | 1 / 73 |
| serious Total, serious adverse events | 3 / 79 | 1 / 73 |
Outcome results
Primary
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.
Time frame: after 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nebulized Amikacin | Bacterial Clearance Rate of Sputum | 38 Participants |
| Nebulized Normal Saline | Bacterial Clearance Rate of Sputum | 16 Participants |
Secondary
Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment
Time frame: after 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebulized Amikacin | Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment | 1.3 L | Standard Deviation 0.7 |
| Nebulized Normal Saline | Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment | 1.5 L | Standard Deviation 0.7 |
Secondary
Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment
Time frame: after 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebulized Amikacin | Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment | 56.9 Percent of Predicted | Standard Deviation 23.9 |
| Nebulized Normal Saline | Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment | 60.0 Percent of Predicted | Standard Deviation 25.3 |
Secondary
Sputum Property Score After 14 Days of Treatment
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.
Time frame: after 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebulized Amikacin | Sputum Property Score After 14 Days of Treatment | 1.3 score on a scale | Standard Deviation 0.6 |
| Nebulized Normal Saline | Sputum Property Score After 14 Days of Treatment | 1.3 score on a scale | Standard Deviation 0.6 |
Secondary
Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment
Time frame: after 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nebulized Amikacin | Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment | 18.4 g | Standard Deviation 20.2 |
| Nebulized Normal Saline | Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment | 16.5 g | Standard Deviation 20.8 |