Trial Outcomes & Findings for Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation (NCT NCT03398213)
NCT ID: NCT03398213
Last Updated: 2020-08-21
Results Overview
modified Borg (mBorg) scale, which is a validated scale that has been used to evaluate the degree of dyspnea (0- no dyspnea, to 10- worse dyspnea)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatment
Results posted on
2020-08-21
Participant Flow
Participant milestones
| Measure |
Acupuncture
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Acupuncture: Acupuncture
N=26
|
Sham Procedure
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Sham procedure: Ear stimulation with plaster
N=24
|
Standard Care
Standard conventional care for COPD exacerbation
N=22
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
22
|
|
Overall Study
COMPLETED
|
26
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Acupuncture
n=26 Participants
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Acupuncture: Acupuncture
|
Sham Procedure
n=24 Participants
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Sham procedure: Ear stimulation with plaster
|
Standard Care
n=22 Participants
Standard conventional care for COPD exacerbation
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 10.1 • n=26 Participants
|
70.7 years
STANDARD_DEVIATION 8.1 • n=24 Participants
|
67.4 years
STANDARD_DEVIATION 9.3 • n=22 Participants
|
69.13 years
STANDARD_DEVIATION 9.2 • n=72 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=26 Participants
|
9 Participants
n=24 Participants
|
5 Participants
n=22 Participants
|
20 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=26 Participants
|
15 Participants
n=24 Participants
|
17 Participants
n=22 Participants
|
52 Participants
n=72 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Dyspnea intensity
|
8 units on a scale
n=26 Participants
|
6.5 units on a scale
n=24 Participants
|
7.75 units on a scale
n=22 Participants
|
7.5 units on a scale
n=72 Participants
|
PRIMARY outcome
Timeframe: At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatmentmodified Borg (mBorg) scale, which is a validated scale that has been used to evaluate the degree of dyspnea (0- no dyspnea, to 10- worse dyspnea)
Outcome measures
| Measure |
Acupuncture
n=26 Participants
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Acupuncture: Acupuncture
|
Sham Procedure
n=24 Participants
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Sham procedure: Ear stimulation with plaster
|
Standard Care
n=22 Participants
Standard conventional care for COPD exacerbation
|
|---|---|---|---|
|
Dyspnea Intensity
Baseline
|
8.0 units on a scale
Interval 5.5 to 8.75
|
6.5 units on a scale
Interval 5.0 to 8.5
|
7.75 units on a scale
Interval 6.0 to 8.5
|
|
Dyspnea Intensity
Day 1 after treatment
|
5 units on a scale
Interval 4.0 to 5.0
|
6 units on a scale
Interval 4.25 to 7.8
|
7 units on a scale
Interval 5.5 to 8.0
|
|
Dyspnea Intensity
Day 2 before treatment
|
5 units on a scale
Interval 3.5 to 7.0
|
6.75 units on a scale
Interval 5.0 to 8.5
|
7.5 units on a scale
Interval 5.8 to 8.3
|
|
Dyspnea Intensity
Day 2 after treatment
|
2 units on a scale
Interval 1.0 to 3.0
|
5 units on a scale
Interval 3.0 to 7.0
|
7.5 units on a scale
Interval 5.0 to 8.0
|
|
Dyspnea Intensity
Day 3 before treatment
|
2.5 units on a scale
Interval 1.0 to 5.0
|
6 units on a scale
Interval 4.5 to 7.3
|
5.75 units on a scale
Interval 4.5 to 7.0
|
|
Dyspnea Intensity
Day 3 after treatment
|
2 units on a scale
Interval 1.0 to 3.0
|
6 units on a scale
Interval 5.0 to 7.0
|
6 units on a scale
Interval 2.0 to 7.0
|
|
Dyspnea Intensity
Day 4 after treatment
|
1 units on a scale
Interval 0.0 to 3.0
|
5 units on a scale
Interval 4.0 to 6.0
|
6 units on a scale
Interval 5.0 to 7.0
|
|
Dyspnea Intensity
Day 4 before treatment
|
3 units on a scale
Interval 0.0 to 5.0
|
5.5 units on a scale
Interval 3.0 to 8.0
|
7 units on a scale
Interval 5.0 to 8.5
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 weekDays of hospitalization
Outcome measures
| Measure |
Acupuncture
n=26 Participants
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Acupuncture: Acupuncture
|
Sham Procedure
n=24 Participants
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Sham procedure: Ear stimulation with plaster
|
Standard Care
n=22 Participants
Standard conventional care for COPD exacerbation
|
|---|---|---|---|
|
Duration of Hospitalization
|
5.5 days
Standard Deviation 2.3
|
6.0 days
Standard Deviation 2.9
|
6.3 days
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Day 1, day 2, day 3, and day 4 of the studyPopulation: Blood gases were not taken daily to all participants
pCO2
Outcome measures
| Measure |
Acupuncture
n=26 Participants
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Acupuncture: Acupuncture
|
Sham Procedure
n=24 Participants
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Sham procedure: Ear stimulation with plaster
|
Standard Care
n=22 Participants
Standard conventional care for COPD exacerbation
|
|---|---|---|---|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 1 · < 45 mmHg
|
6 Participants
|
3 Participants
|
8 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 1 · 45-60 mmHg
|
12 Participants
|
17 Participants
|
9 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 1 · 60-80 mmHg
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 1 · > 80 mmHg
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 2 · < 45 mmHg
|
4 Participants
|
7 Participants
|
1 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 2 · 45-60 mmHg
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 2 · 60-80 mmHg
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 2 · > 80 mmHg
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 3 · < 45 mmHg
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 3 · 45-60 mmHg
|
5 Participants
|
9 Participants
|
3 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 3 · 60-80 mmHg
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 3 · > 80 mmHg
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 4 · < 45 mmHg
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 4 · 45-60 mmHg
|
1 Participants
|
6 Participants
|
0 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 4 · 60-80 mmHg
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Carbon Dioxide Partial Pressure (pCO2)
Day 4 · > 80 mmHg
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1, day 2, day 3, and day 4 of the studyPopulation: Blood gases were not measured daily in all participants
pH
Outcome measures
| Measure |
Acupuncture
n=26 Participants
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Acupuncture: Acupuncture
|
Sham Procedure
n=24 Participants
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Sham procedure: Ear stimulation with plaster
|
Standard Care
n=22 Participants
Standard conventional care for COPD exacerbation
|
|---|---|---|---|
|
Power of Hydrogen (pH)
Day 1 · < 7.2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Power of Hydrogen (pH)
Day 1 · 7.2-7.3
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Power of Hydrogen (pH)
Day 1 · > 7.3
|
21 Participants
|
20 Participants
|
21 Participants
|
|
Power of Hydrogen (pH)
Day 2 · < 7.2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Power of Hydrogen (pH)
Day 2 · 7.2-7.3
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Power of Hydrogen (pH)
Day 2 · > 7.3
|
12 Participants
|
16 Participants
|
4 Participants
|
|
Power of Hydrogen (pH)
Day 3 · < 7.2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Power of Hydrogen (pH)
Day 4 · < 7.2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Power of Hydrogen (pH)
Day 4 · 7.2-7.3
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Power of Hydrogen (pH)
Day 4 · > 7.3
|
6 Participants
|
11 Participants
|
4 Participants
|
|
Power of Hydrogen (pH)
Day 3 · 7.2-7.3
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Power of Hydrogen (pH)
Day 3 · > 7.3
|
7 Participants
|
14 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatmentRespiratory rate
Outcome measures
| Measure |
Acupuncture
n=26 Participants
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Acupuncture: Acupuncture
|
Sham Procedure
n=24 Participants
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Sham procedure: Ear stimulation with plaster
|
Standard Care
n=22 Participants
Standard conventional care for COPD exacerbation
|
|---|---|---|---|
|
Respiratory Rate
Baseline (day 1)
|
21 breaths per minute
Interval 16.0 to 23.75
|
22 breaths per minute
Interval 16.5 to 26.0
|
20 breaths per minute
Interval 16.0 to 22.0
|
|
Respiratory Rate
Day 1 after treatment
|
16 breaths per minute
Interval 14.0 to 20.0
|
18 breaths per minute
Interval 16.0 to 20.5
|
21 breaths per minute
Interval 18.0 to 26.0
|
|
Respiratory Rate
Day 2 before treatment
|
18 breaths per minute
Interval 16.0 to 22.0
|
20 breaths per minute
Interval 16.0 to 25.0
|
22 breaths per minute
Interval 16.0 to 24.0
|
|
Respiratory Rate
Day 2 after treatment
|
16 breaths per minute
Interval 12.0 to 16.0
|
18 breaths per minute
Interval 16.0 to 21.5
|
26 breaths per minute
Interval 21.0 to 30.0
|
|
Respiratory Rate
Day 3 before treatment
|
16 breaths per minute
Interval 14.0 to 29.0
|
18 breaths per minute
Interval 16.0 to 24.0
|
18 breaths per minute
Interval 16.0 to 22.0
|
|
Respiratory Rate
Day 3 after treatment
|
14 breaths per minute
Interval 12.0 to 20.0
|
16 breaths per minute
Interval 16.0 to 24.0
|
24 breaths per minute
Interval 18.0 to 24.0
|
|
Respiratory Rate
Day 4 before treatment
|
16 breaths per minute
Interval 14.0 to 29.0
|
16 breaths per minute
Interval 16.0 to 23.0
|
18 breaths per minute
Interval 16.0 to 18.0
|
|
Respiratory Rate
Day 4 after treatment
|
13 breaths per minute
Interval 12.0 to 17.0
|
16 breaths per minute
Interval 14.0 to 20.0
|
22 breaths per minute
Interval 18.0 to 26.0
|
SECONDARY outcome
Timeframe: Day 1, day 2, day 3, and day 4 of the studyPopulation: Oxygen saturation is missing for some participants in days 2, 3 and 4
Oxygen saturation
Outcome measures
| Measure |
Acupuncture
n=26 Participants
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Acupuncture: Acupuncture
|
Sham Procedure
n=24 Participants
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Sham procedure: Ear stimulation with plaster
|
Standard Care
n=22 Participants
Standard conventional care for COPD exacerbation
|
|---|---|---|---|
|
Oxygen Saturation
Day 1 · 81-89%
|
9 Participants
|
10 Participants
|
10 Participants
|
|
Oxygen Saturation
Day 1 · >= 90%
|
13 Participants
|
13 Participants
|
12 Participants
|
|
Oxygen Saturation
Day 2 · =< 80%
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Oxygen Saturation
Day 2 · 81-89%
|
10 Participants
|
10 Participants
|
5 Participants
|
|
Oxygen Saturation
Day 2 · >= 90%
|
12 Participants
|
10 Participants
|
12 Participants
|
|
Oxygen Saturation
Day 3 · =< 80%
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Oxygen Saturation
Day 3 · 81-89%
|
10 Participants
|
7 Participants
|
6 Participants
|
|
Oxygen Saturation
Day 3 · >= 90%
|
9 Participants
|
13 Participants
|
11 Participants
|
|
Oxygen Saturation
Day 4 · =< 80%
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Oxygen Saturation
Day 4 · 81-89%
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Oxygen Saturation
Day 4 · >= 90%
|
6 Participants
|
14 Participants
|
12 Participants
|
|
Oxygen Saturation
Day 1 · =< 80%
|
4 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, day 2, day 3, and day 4 of the studyVisual Analogue Scale (VAS) for cough (0- no cough, to 10- worse cough)
Outcome measures
| Measure |
Acupuncture
n=26 Participants
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Acupuncture: Acupuncture
|
Sham Procedure
n=24 Participants
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Sham procedure: Ear stimulation with plaster
|
Standard Care
n=22 Participants
Standard conventional care for COPD exacerbation
|
|---|---|---|---|
|
Cough Intensity
Day 1
|
7.5 units on a scale
Interval 5.0 to 8.0
|
5.0 units on a scale
Interval 5.0 to 7.3
|
5.0 units on a scale
Interval 4.0 to 7.5
|
|
Cough Intensity
Day 2
|
4.5 units on a scale
Interval 1.5 to 5.5
|
5 units on a scale
Interval 2.5 to 7.5
|
5 units on a scale
Interval 4.5 to 7.5
|
|
Cough Intensity
Day 3
|
3 units on a scale
Interval 1.0 to 5.0
|
5 units on a scale
Interval 3.3 to 7.3
|
5 units on a scale
Interval 2.5 to 7.5
|
|
Cough Intensity
Day 4
|
2.5 units on a scale
Interval 2.0 to 4.0
|
4.5 units on a scale
Interval 2.5 to 6.0
|
5 units on a scale
Interval 0.0 to 7.5
|
SECONDARY outcome
Timeframe: Day 1, day 2, day 3, and day 4 of the studyVisual Analogue Scale (VAS) for sputum (0- no sputum, to 10- worse sputum)
Outcome measures
| Measure |
Acupuncture
n=26 Participants
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Acupuncture: Acupuncture
|
Sham Procedure
n=24 Participants
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Sham procedure: Ear stimulation with plaster
|
Standard Care
n=22 Participants
Standard conventional care for COPD exacerbation
|
|---|---|---|---|
|
Sputum Intensity
Day 1
|
6.0 units on a scale
Interval 2.0 to 7.5
|
6.0 units on a scale
Interval 4.5 to 6.0
|
5.0 units on a scale
Interval 2.5 to 6.0
|
|
Sputum Intensity
Day 2
|
2.8 units on a scale
Interval 1.0 to 4.5
|
5.5 units on a scale
Interval 2.0 to 6.0
|
4.5 units on a scale
Interval 2.5 to 5.5
|
|
Sputum Intensity
Day 3
|
2 units on a scale
Interval 1.0 to 4.0
|
5 units on a scale
Interval 3.5 to 6.0
|
4.5 units on a scale
Interval 2.5 to 5.0
|
|
Sputum Intensity
Day 4
|
2 units on a scale
Interval 1.0 to 4.0
|
5 units on a scale
Interval 3.0 to 6.0
|
5 units on a scale
Interval 2.5 to 6.0
|
Adverse Events
Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place