A Phase 4 interventional study of Amikacin and Normal saline in Non-Cystic Fibrosis Bronchiectasis, sponsored by Qilu Hospital of Shandong University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-24.
Sponsored by Qilu Hospital of Shandong University · Phase 4, Interventional, and Treatment
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.
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.
368 studies on the registry are indexed under Bronchiectasis; 105 are open to participants now.
This study's enrollment of 178 is above the median of 60 across 233 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.
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Exclusion Criteria:
Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.
Drug: Amikacin
Participants received nebulized normal saline BID for 14 days in combination with standard treatment.
Drug: Normal saline
Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.
Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.
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
Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment
Time frame: after 14 days
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
Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment
Time frame: after 14 days
Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment
Time frame: after 14 days
Eligible patients were screened and randomized at five tertiary hospitals in Shandong Province, China.
| Milestone | Nebulized Amikacin | Nebulized Normal Saline |
|---|---|---|
| Started | 79 | 73 |
| Completed | 74 | 69 |
| Not completed | 5 | 4 |
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.
| Participants | Nebulized Amikacin | Nebulized Normal Saline |
|---|---|---|
| Bacterial Clearance Rate of Sputum | 38 | 16 |
| g | Nebulized Amikacin | Nebulized Normal Saline |
|---|---|---|
| Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment | 18.4 ± 20.2 | 16.5 ± 20.8 |
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.
| score on a scale | Nebulized Amikacin | Nebulized Normal Saline |
|---|---|---|
| Sputum Property Score After 14 Days of Treatment | 1.3 ± 0.6 | 1.3 ± 0.6 |
| Percent of Predicted | Nebulized Amikacin | Nebulized Normal Saline |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment | 56.9 ± 23.9 | 60.0 ± 25.3 |
| L | Nebulized Amikacin | Nebulized Normal Saline |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment | 1.3 ± 0.7 | 1.5 ± 0.7 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nebulized Amikacin | 1/79 (1.3%) | 3/79 (3.8%) | 1/79 (1.3%) |
| Nebulized Normal Saline | 1/73 (1.4%) | 1/73 (1.4%) | 1/73 (1.4%) |
| Event | Nebulized Amikacin | Nebulized Normal Saline |
|---|---|---|
| bronchospasmsRespiratory, thoracic and mediastinal disorders | 2/79 | 1/73 |
| nauseaGastrointestinal disorders | 1/79 | 0/73 |
| Event | Nebulized Amikacin | Nebulized Normal Saline |
|---|---|---|
| nauseaGastrointestinal disorders | 1/79 | 1/73 |
| Age, Categorical(Participants) | Nebulized Amikacin | Nebulized Normal Saline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 70 | 67 | 137 |
| >=65 years | 9 | 6 | 15 |
| Age, Continuous(years) | Nebulized Amikacin | Nebulized Normal Saline | Total |
|---|---|---|---|
| Mean | 57.3 ± 13.0 | 56.5 ± 10.8 | 56.9 ± 11.8 |
| Sex: Female, Male(Participants) | Nebulized Amikacin | Nebulized Normal Saline | Total |
|---|---|---|---|
| Female | 46 | 37 | 83 |
| Male | 28 | 32 | 60 |
| Race and Ethnicity Not Collected(Participants) | Nebulized Amikacin | Nebulized Normal Saline | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Nebulized Amikacin | Nebulized Normal Saline | Total |
|---|---|---|---|
| China | 74 | 69 | 143 |
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Qilu Hospital of Shandong University