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Trial record 93 of 225 for:    Bronchiectasis

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

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ClinicalTrials.gov Identifier: NCT02081963
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : April 15, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Qian Qi, Qilu Hospital of Shandong University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Cystic Fibrosis Bronchiectasis
Interventions Drug: Amikacin
Drug: Normal saline
Enrollment 178
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.
Arm/Group Title Nebulized Amikacin Nebulized Normal Saline
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 79 73
Completed 74 69
Not Completed 5 4
Arm/Group Title Nebulized Amikacin Nebulized Normal Saline Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 79 73 152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 73 participants 152 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
70
  88.6%
67
  91.8%
137
  90.1%
>=65 years
9
  11.4%
6
   8.2%
15
   9.9%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 69 participants 143 participants
57.3  (13.0) 56.5  (10.8) 56.9  (11.8)
[1]
Measure Analysis Population Description: Nine patients were excluded from the final analysis due to dropout, 5 in the intervention group (6.3%) and 4 in the control group (5.6%).
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 69 participants 143 participants
Female
46
  62.2%
37
  53.6%
83
  58.0%
Male
28
  37.8%
32
  46.4%
60
  42.0%
[1]
Measure Analysis Population Description: Nine patients were excluded from the final analysis due to dropout, 5 in the intervention group (6.3%) and 4 in the control group (5.6%).
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 74 participants 69 participants 143 participants
74 69 143
[1]
Measure Analysis Population Description: Nine patients were excluded from the final analysis due to dropout, 5 in the intervention group (6.3%) and 4 in the control group (5.6%).
1.Primary Outcome
Title Bacterial Clearance Rate of Sputum
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebulized Amikacin Nebulized Normal Saline
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 74 69
Measure Type: Count of Participants
Unit of Measure: Participants
38
  51.4%
16
  23.2%
2.Secondary Outcome
Title Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment
Hide Description [Not Specified]
Time Frame after 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebulized Amikacin Nebulized Normal Saline
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 74 69
Mean (Standard Deviation)
Unit of Measure: g
18.4  (20.2) 16.5  (20.8)
3.Secondary Outcome
Title Sputum Property Score After 14 Days of Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebulized Amikacin Nebulized Normal Saline
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 74 69
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.3  (0.6) 1.3  (0.6)
4.Secondary Outcome
Title Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment
Hide Description [Not Specified]
Time Frame after 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebulized Amikacin Nebulized Normal Saline
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 74 69
Mean (Standard Deviation)
Unit of Measure: Percent of Predicted
56.9  (23.9) 60.0  (25.3)
5.Secondary Outcome
Title Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment
Hide Description [Not Specified]
Time Frame after 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebulized Amikacin Nebulized Normal Saline
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 74 69
Mean (Standard Deviation)
Unit of Measure: L
1.3  (0.7) 1.5  (0.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nebulized Amikacin Nebulized Normal Saline
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Nebulized Amikacin Nebulized Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   1/79 (1.27%)   1/73 (1.37%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nebulized Amikacin Nebulized Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   3/79 (3.80%)   1/73 (1.37%) 
Gastrointestinal disorders     
nausea *  1/79 (1.27%)  0/73 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
bronchospasms *  2/79 (2.53%)  1/73 (1.37%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Nebulized Amikacin Nebulized Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   1/79 (1.27%)   1/73 (1.37%) 
Gastrointestinal disorders     
nausea   1/79 (1.27%)  1/73 (1.37%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr.Yu Li
Organization: Department of Respiratory Medicine, Qilu Hospital of Shandong University
Phone: 13791122770
Responsible Party: Qian Qi, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT02081963     History of Changes
Other Study ID Numbers: NCFB-AMK-01
First Submitted: March 6, 2014
First Posted: March 7, 2014
Results First Submitted: July 5, 2018
Results First Posted: April 15, 2019
Last Update Posted: April 24, 2019