Trial Outcomes & Findings for Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis (NCT NCT02081963)

NCT ID: NCT02081963

Last Updated: 2019-04-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 178 participants
• Primary outcome timeframe: after 14 days
• Results posted on: 2019-04-24

Participant Flow

Eligible patients were screened and randomized at five tertiary hospitals in Shandong Province, China.

A total of 178 patients were screened in this study, and 26 unquali-fied patients (14.6%) were excluded.

Participant milestones

Measure	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.	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.
Overall Study STARTED	79	73
Overall Study COMPLETED	74	69
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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%).

Baseline characteristics by cohort

Measure	Nebulized Amikacin n=79 Participants 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.	Nebulized Normal Saline n=73 Participants 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 n=152 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=79 Participants	0 Participants n=73 Participants	0 Participants n=152 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=79 Participants	67 Participants n=73 Participants	137 Participants n=152 Participants
Age, Categorical >=65 years	9 Participants n=79 Participants	6 Participants n=73 Participants	15 Participants n=152 Participants
Age, Continuous	57.3 years STANDARD_DEVIATION 13.0 • n=74 Participants • 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%).	56.5 years STANDARD_DEVIATION 10.8 • n=69 Participants • 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%).	56.9 years STANDARD_DEVIATION 11.8 • n=143 Participants • 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 Female	46 Participants n=74 Participants • 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%).	37 Participants n=69 Participants • 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%).	83 Participants n=143 Participants • 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 Male	28 Participants n=74 Participants • 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%).	32 Participants n=69 Participants • 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%).	60 Participants n=143 Participants • 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	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	74 participants n=74 Participants • 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%).	69 participants n=69 Participants • 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%).	143 participants n=143 Participants • 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%).

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Nebulized Amikacin n=74 Participants 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.	Nebulized Normal Saline n=69 Participants 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.
Bacterial Clearance Rate of Sputum	38 Participants	16 Participants

SECONDARY outcome

Timeframe: after 14 days

Outcome measures

Measure	Nebulized Amikacin n=74 Participants 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.	Nebulized Normal Saline n=69 Participants 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 Sputum Weight (Collected Over 24 h) After 14 Days of Treatment	18.4 g Standard Deviation 20.2	16.5 g Standard Deviation 20.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Nebulized Amikacin n=74 Participants 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.	Nebulized Normal Saline n=69 Participants 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.
Sputum Property Score After 14 Days of Treatment	1.3 score on a scale Standard Deviation 0.6	1.3 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: after 14 days

Outcome measures

Measure	Nebulized Amikacin n=74 Participants 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.	Nebulized Normal Saline n=69 Participants 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.
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	60.0 Percent of Predicted Standard Deviation 25.3

SECONDARY outcome

Timeframe: after 14 days

Outcome measures

Measure	Nebulized Amikacin n=74 Participants 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.	Nebulized Normal Saline n=69 Participants 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.
Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment	1.3 L Standard Deviation 0.7	1.5 L Standard Deviation 0.7

Adverse Events

Nebulized Amikacin

Serious events: 3 serious events

Other events: 1 other events

Deaths: 1 deaths

Nebulized Normal Saline

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	Nebulized Amikacin n=79 participants at risk 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.	Nebulized Normal Saline n=73 participants at risk 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.
Respiratory, thoracic and mediastinal disorders bronchospasms	2.5% 2/79	1.4% 1/73
Gastrointestinal disorders nausea	1.3% 1/79	0.00% 0/73

Other adverse events

Measure	Nebulized Amikacin n=79 participants at risk 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.	Nebulized Normal Saline n=73 participants at risk 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.
Gastrointestinal disorders nausea	1.3% 1/79	1.4% 1/73

Additional Information

Dr.Yu Li

Department of Respiratory Medicine, Qilu Hospital of Shandong University

Phone: 13791122770

Email: qlliyu@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place