Trial · NCT02081963
Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
NCT02081963, Phase 4, Completed, Qilu Hospital of Shandong University; results first posted 2019-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis. Trials, record NCT02081963. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02081963
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis
- NCT number
- NCT02081963
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 178 participants, actual
- Lead sponsor
- Qilu Hospital of Shandong University
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Interventions
- Amikacin, Normal saline
- First posted
- 2014-03-07
- Last updated
- 2019-04-24
- Results first posted
- 2019-04-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment | after 14 days | |
| Secondary | 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. |
| Secondary | Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment | after 14 days | |
| Secondary | Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment | after 14 days |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bacterial Clearance Rate of Sputum | after 14 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment | after 14 days | g | MEAN | |
| SECONDARY | Sputum Property Score After 14 Days of Treatment | after 14 days | score on a scale | MEAN | |
| SECONDARY | Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment | after 14 days | Percent of Predicted | MEAN | |
| SECONDARY | Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment | after 14 days | L | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bacterial Clearance Rate of Sputum | Nebulized Amikacin | 38 | Participants | ||
| Bacterial Clearance Rate of Sputum | Nebulized Normal Saline | 16 | Participants | ||
| Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment | Nebulized Amikacin | 18.4 | Standard Deviation 20.2 | g | |
| Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment | Nebulized Normal Saline | 16.5 | Standard Deviation 20.8 | g | |
| Sputum Property Score After 14 Days of Treatment | Nebulized Amikacin | 1.3 | Standard Deviation 0.6 | score on a scale | |
| Sputum Property Score After 14 Days of Treatment | Nebulized Normal Saline | 1.3 | Standard Deviation 0.6 | score on a scale | |
| Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment | Nebulized Amikacin | 56.9 | Standard Deviation 23.9 | Percent of Predicted | |
| Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment | Nebulized Normal Saline | 60.0 | Standard Deviation 25.3 | Percent of Predicted | |
| Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment | Nebulized Amikacin | 1.3 | Standard Deviation 0.7 | L | |
| Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment | Nebulized Normal Saline | 1.5 | Standard Deviation 0.7 | L |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nebulized Amikacin | 79 | |
| Overall Study | STARTED | Nebulized Normal Saline | 73 | |
| Overall Study | COMPLETED | Nebulized Amikacin | 74 | |
| Overall Study | COMPLETED | Nebulized Normal Saline | 69 | |
| Overall Study | NOT COMPLETED | Nebulized Amikacin | 5 | |
| Overall Study | NOT COMPLETED | Nebulized Normal Saline | 4 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nausea | Gastrointestinal disorders | Nebulized Amikacin | 1 | 79 | |
| other | nausea | Gastrointestinal disorders | Nebulized Normal Saline | 1 | 73 | |
| serious | bronchospasms | Respiratory, thoracic and mediastinal disorders | Nebulized Amikacin | 2 | 79 | |
| serious | bronchospasms | Respiratory, thoracic and mediastinal disorders | Nebulized Normal Saline | 1 | 73 | |
| serious | nausea | Gastrointestinal disorders | Nebulized Amikacin | 1 | 79 | |
| serious | nausea | Gastrointestinal disorders | Nebulized Normal Saline | 0 | 73 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nebulized Amikacin | 1 | 79 |
| Total, all-cause mortality | Nebulized Normal Saline | 1 | 73 |
| Total, other adverse events | Nebulized Amikacin | 1 | 79 |
| Total, other adverse events | Nebulized Normal Saline | 1 | 73 |
| Total, serious adverse events | Nebulized Amikacin | 3 | 79 |
| Total, serious adverse events | Nebulized Normal Saline | 1 | 73 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nebulized Amikacin vs Nebulized Normal Saline: Bacterial Clearance Rate of Sputum | Trial comparisons |
| Nebulized Amikacin vs Nebulized Normal Saline: deaths from any cause | Trial comparisons |
| Nebulized Amikacin vs Nebulized Normal Saline: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02081963
GET https://conductscience.org/api/trials/v1/NCT02081963/registered