Trial Outcomes & Findings for Acute Effects of a Flutter Device in COPD (NCT NCT01832961)
NCT ID: NCT01832961
Last Updated: 2020-02-27
Results Overview
Airways resistance were measured by impulse oscillometry (IOS) method.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest
Results posted on
2020-02-27
Participant Flow
Participant milestones
| Measure |
Flutter Valve, Then Flutter Sham and Flutter+Bronchodilator
Visit 1: medical history, physical examination and written informed consent
Visit 2: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device
Visit 3: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises
Visit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
|
Flutter Sham, Then Flutter Valve and Flutter+Bronchodilator
Visit 1: medical history, physical examination and written informed consent
Visit 2: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises
Visit 3: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device
Visit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
|
|---|---|---|
|
First Intervention
STARTED
|
8
|
7
|
|
First Intervention
COMPLETED
|
8
|
7
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
8
|
7
|
|
Washout
COMPLETED
|
8
|
7
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
8
|
7
|
|
Second Intervention
COMPLETED
|
8
|
7
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
|
Third Intervention
STARTED
|
8
|
7
|
|
Third Intervention
COMPLETED
|
8
|
7
|
|
Third Intervention
NOT COMPLETED
|
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 |
All Patient
n=15 Participants
All volunteers had a following treatments as crossover design Visit 1: medical history, physical examination and written informed consent
Visit 2: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device
Visit 3: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises
Visit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
|
|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 9.1 • n=15 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=15 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of restPopulation: Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis, and no recent history of rib fractures or pneumothorax. In the Flutter-sham Control group after 20 minutes of rest - no data was collected.
Airways resistance were measured by impulse oscillometry (IOS) method.
Outcome measures
| Measure |
Flutter Exercises Session
n=15 Participants
30 minutes of breathing exercises with flutter device
|
Flutter+Bronchodilator Session
n=15 Participants
Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
|
Flutter-sham - Control Group
n=15 Participants
30 minutes of exercise with flutter-sham device
|
|---|---|---|---|
|
Airways Resistance (IOS)
R5 (kPa/L/s) Baseline
|
0.63 kPa/L/s
Standard Deviation 0.16
|
0.61 kPa/L/s
Standard Deviation 0.28
|
0.58 kPa/L/s
Standard Deviation 0.15
|
|
Airways Resistance (IOS)
R5 (kPa/L/s) Immediately after
|
0.68 kPa/L/s
Standard Deviation 0.21
|
0.63 kPa/L/s
Standard Deviation 0.26
|
0.60 kPa/L/s
Standard Deviation 0.22
|
|
Airways Resistance (IOS)
R5 (kPa/L/s) After 20 minutes of rest
|
0.61 kPa/L/s
Standard Deviation 0.18
|
0.56 kPa/L/s
Standard Deviation 0.24
|
NA kPa/L/s
Standard Deviation NA
No data was collected from this group after 20 minuted of rest.
|
|
Airways Resistance (IOS)
R20 (kPa/L/s) Baseline
|
0.42 kPa/L/s
Standard Deviation 0.12
|
0.41 kPa/L/s
Standard Deviation 0.15
|
0.40 kPa/L/s
Standard Deviation 0.15
|
|
Airways Resistance (IOS)
R20 (kPa/L/s) Immediately after
|
0.43 kPa/L/s
Standard Deviation 0.14
|
0.42 kPa/L/s
Standard Deviation 0.16
|
0.41 kPa/L/s
Standard Deviation 0.13
|
|
Airways Resistance (IOS)
R20 (kPa/L/s) After 20 minutes of rest
|
0.41 kPa/L/s
Standard Deviation 0.15
|
0.39 kPa/L/s
Standard Deviation 0.14
|
NA kPa/L/s
Standard Deviation NA
No data was collected from this group after 20 minuted of rest.
|
|
Airways Resistance (IOS)
R5-R20 (kPa/L/s) Baseline
|
0.21 kPa/L/s
Standard Deviation 0.08
|
0.20 kPa/L/s
Standard Deviation 0.15
|
0.19 kPa/L/s
Standard Deviation 0.10
|
|
Airways Resistance (IOS)
R5-R20 (kPa/L/s) Immediately after
|
0.25 kPa/L/s
Standard Deviation 0.10
|
0.21 kPa/L/s
Standard Deviation 0.12
|
0.19 kPa/L/s
Standard Deviation 0.11
|
|
Airways Resistance (IOS)
R5-R20 (kPa/L/s) After 20 minutes of rest
|
0.20 kPa/L/s
Standard Deviation 0.06
|
0.18 kPa/L/s
Standard Deviation 0.25
|
NA kPa/L/s
Standard Deviation NA
No data was collected from this group after 20 minuted of rest.
|
|
Airways Resistance (IOS)
X5 (kPa/L/s) Baseline
|
-0.27 kPa/L/s
Standard Deviation 0.10
|
-0.27 kPa/L/s
Standard Deviation 0.15
|
-0.23 kPa/L/s
Standard Deviation 0.08
|
|
Airways Resistance (IOS)
X5 (kPa/L/s) Immediately after
|
-0.28 kPa/L/s
Standard Deviation 0.11
|
-0.25 kPa/L/s
Standard Deviation 0.11
|
-0.24 kPa/L/s
Standard Deviation 0.09
|
|
Airways Resistance (IOS)
X5 (kPa/L/s) After 20 minutes of rest
|
-0.26 kPa/L/s
Standard Deviation 0.10
|
-0.25 kPa/L/s
Standard Deviation 0.12
|
NA kPa/L/s
Standard Deviation NA
No data was collected from this group after 20 minuted of rest.
|
PRIMARY outcome
Timeframe: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of restPopulation: No data was collected from the Flutter-sham Control group after 20 minutes of rest.
Airways resistance were measured by impulse oscillometry (IOS) method.
Outcome measures
| Measure |
Flutter Exercises Session
n=15 Participants
30 minutes of breathing exercises with flutter device
|
Flutter+Bronchodilator Session
n=15 Participants
Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
|
Flutter-sham - Control Group
n=15 Participants
30 minutes of exercise with flutter-sham device
|
|---|---|---|---|
|
Airways Resistance (IOS) - Reactance Area (Ax)
Ax (kPa/L) Baseline
|
-0.13 kPa/L
Standard Deviation 0.17
|
-0.19 kPa/L
Standard Deviation 0.30
|
1.89 kPa/L
Standard Deviation 1.18
|
|
Airways Resistance (IOS) - Reactance Area (Ax)
Ax (kPa/L) Immediately after
|
-0.06 kPa/L
Standard Deviation 0.20
|
-0.20 kPa/L
Standard Deviation 0.26
|
2.22 kPa/L
Standard Deviation 1.62
|
|
Airways Resistance (IOS) - Reactance Area (Ax)
Ax (kPa/L) After 20 minutes of rest
|
-0.10 kPa/L
Standard Deviation 0.16
|
-0.18 kPa/L
Standard Deviation 0.26
|
NA kPa/L
Standard Deviation NA
No data was collected from this group after 20 minutes of rest.
|
PRIMARY outcome
Timeframe: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of restPopulation: No data was collected from the Flutter-sham Control group after 20 minutes of rest.
Airways resistance were measured by impulse oscillometry (IOS) method.
Outcome measures
| Measure |
Flutter Exercises Session
n=15 Participants
30 minutes of breathing exercises with flutter device
|
Flutter+Bronchodilator Session
n=15 Participants
Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
|
Flutter-sham - Control Group
n=15 Participants
30 minutes of exercise with flutter-sham device
|
|---|---|---|---|
|
Airways Resistance (IOS) - Resonant Frequency (Fres)
Fres (Hz) Baseline
|
24.95 Hz
Standard Deviation 4.03
|
22.54 Hz
Standard Deviation 7.70
|
22.13 Hz
Standard Deviation 5.71
|
|
Airways Resistance (IOS) - Resonant Frequency (Fres)
Fres (Hz) Immediately after
|
26.15 Hz
Standard Deviation 4.78
|
23.49 Hz
Standard Deviation 6.14
|
22.41 Hz
Standard Deviation 8.24
|
|
Airways Resistance (IOS) - Resonant Frequency (Fres)
Fres (Hz) After 20 minutes of rest
|
24.24 Hz
Standard Deviation 4.29
|
21.85 Hz
Standard Deviation 7.01
|
NA Hz
Standard Deviation NA
No data was collect from this group after 20 minutes of rest.
|
SECONDARY outcome
Timeframe: Baseline and immediately after interventionPopulation: Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.
Exhaled nitric oxide will be measured by chemiluminescence method.
Outcome measures
| Measure |
Flutter Exercises Session
n=15 Participants
30 minutes of breathing exercises with flutter device
|
Flutter+Bronchodilator Session
n=15 Participants
Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
|
Flutter-sham - Control Group
n=15 Participants
30 minutes of exercise with flutter-sham device
|
|---|---|---|---|
|
Exhaled Nitric Oxide (FeNO)
Baseline
|
40.5 parts per billion
Standard Deviation 29.9
|
44.4 parts per billion
Standard Deviation 33.7
|
32.3 parts per billion
Standard Deviation 29.4
|
|
Exhaled Nitric Oxide (FeNO)
After intervention
|
39.3 parts per billion
Standard Deviation 33.7
|
43.6 parts per billion
Standard Deviation 33.2
|
31.7 parts per billion
Standard Deviation 32.0
|
SECONDARY outcome
Timeframe: Baseline and immediately after interventionPopulation: Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.
Forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) were measured using a dry wedge spirometer (Jaeger Co, Wurzburg, Germany)
Outcome measures
| Measure |
Flutter Exercises Session
n=15 Participants
30 minutes of breathing exercises with flutter device
|
Flutter+Bronchodilator Session
n=15 Participants
Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
|
Flutter-sham - Control Group
n=15 Participants
30 minutes of exercise with flutter-sham device
|
|---|---|---|---|
|
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
Baseline FVC (%)
|
109.4 percent predicted spirometry assessment
Standard Deviation 18.4
|
109.8 percent predicted spirometry assessment
Standard Deviation 19.6
|
105.8 percent predicted spirometry assessment
Standard Deviation 16.2
|
|
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
After intervention FVC (%)
|
107.3 percent predicted spirometry assessment
Standard Deviation 18.1
|
109.0 percent predicted spirometry assessment
Standard Deviation 17.5
|
102.1 percent predicted spirometry assessment
Standard Deviation 18.0
|
|
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
Baseline FEV1 (%)
|
67.6 percent predicted spirometry assessment
Standard Deviation 17.7
|
67.0 percent predicted spirometry assessment
Standard Deviation 17.3
|
62.1 percent predicted spirometry assessment
Standard Deviation 16.7
|
|
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
After intervention FEV1 (%)
|
66.0 percent predicted spirometry assessment
Standard Deviation 15.5
|
65.3 percent predicted spirometry assessment
Standard Deviation 14.6
|
60.3 percent predicted spirometry assessment
Standard Deviation 17.1
|
|
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
Baseline FEV1/FVC (%)
|
51.0 percent predicted spirometry assessment
Standard Deviation 13.0
|
50.3 percent predicted spirometry assessment
Standard Deviation 12.0
|
48.5 percent predicted spirometry assessment
Standard Deviation 12.8
|
|
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
After intervention FEV1/FVC (%)
|
51.0 percent predicted spirometry assessment
Standard Deviation 12.5
|
49.7 percent predicted spirometry assessment
Standard Deviation 10.8
|
48.9 percent predicted spirometry assessment
Standard Deviation 12.8
|
|
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
Baseline MEF 25-75 (%)
|
18.93 percent predicted spirometry assessment
Standard Deviation 8.0
|
17.8 percent predicted spirometry assessment
Standard Deviation 6.8
|
15.7 percent predicted spirometry assessment
Standard Deviation 6.4
|
|
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
After intervention MEF 25-75 (%)
|
18.0 percent predicted spirometry assessment
Standard Deviation 7.1
|
17.6 percent predicted spirometry assessment
Standard Deviation 6.9
|
15.1 percent predicted spirometry assessment
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: During each sessionPopulation: Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.
Number of spontaneously reported cough episodes during each visit were collected.
Outcome measures
| Measure |
Flutter Exercises Session
n=15 Participants
30 minutes of breathing exercises with flutter device
|
Flutter+Bronchodilator Session
n=15 Participants
Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
|
Flutter-sham - Control Group
n=15 Participants
30 minutes of exercise with flutter-sham device
|
|---|---|---|---|
|
Cough
|
3.95 Coughs
Standard Deviation 2.41
|
1.69 Coughs
Standard Deviation 1.49
|
3.63 Coughs
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: During each sessionPopulation: COPD patients without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of a rib fracture or pneumothorax The volume fo secretion was obtained only for two groups: Flutter exercises and flutter-sham exercises.
Expectorated secretion volume during each visit were collected, weighted and classified with a purulence score.
Outcome measures
| Measure |
Flutter Exercises Session
n=15 Participants
30 minutes of breathing exercises with flutter device
|
Flutter+Bronchodilator Session
n=15 Participants
Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
|
Flutter-sham - Control Group
30 minutes of exercise with flutter-sham device
|
|---|---|---|---|
|
Secretion - Volume
|
2.54 grams
Standard Deviation 1.39
|
1.5 grams
Standard Deviation 1.33
|
—
|
SECONDARY outcome
Timeframe: In each sessionPopulation: COPD patients without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of a rib fracture or pneumothorax.
The expectorated secretion was collected, weighted and classified with a purulence score based on a previously described numerical visual scale, which ranges from 1 (mucoid) to 5 (yellow/green). Referee of the Purulence score: Barnes PJ, Dweik RA, Gelb AF, et al. Exhaled nitric oxide in pulmonary diseases: a comprehensive review. Chest. 2010;138:682-692.
Outcome measures
| Measure |
Flutter Exercises Session
n=15 Participants
30 minutes of breathing exercises with flutter device
|
Flutter+Bronchodilator Session
n=15 Participants
Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device
|
Flutter-sham - Control Group
n=15 Participants
30 minutes of exercise with flutter-sham device
|
|---|---|---|---|
|
Secretion - Purulence Score
|
2.30 score on a scale
Standard Deviation 0.82
|
2.57 score on a scale
Standard Deviation 0.79
|
2.60 score on a scale
Standard Deviation 1.34
|
Adverse Events
Flutter Exercises
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flutter-sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flutter+Bronchodilator
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