Trial Outcomes & Findings for The Use of Airway Clearance Devices in ALS (NCT NCT02682030)
NCT ID: NCT02682030
Last Updated: 2020-08-25
Results Overview
A projection radiograph of the chest used to diagnose conditions affecting the chest. Chest X-Ray performed at each study visit. Investigator looked at clinical impression of Chest X-ray to be normal versus abnormal. If there was presence of atelectasis, this indicated a worsening of subject's respiratory symptoms. If subject's Chest X-Ray impression remained the same and continually normal, this indicated no change in respiratory symptoms.
COMPLETED
NA
5 participants
1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 X-rays over 6 months.
2020-08-25
Participant Flow
Patients were recruited internally at Cedars-Sinai Medical Center ALS multidisciplinary clinic.
5 participants met inclusion criteria and were enrolled into the study. One participant was randomized to the Treatment Group A HFCC Only arm while 4 participants were randomized to the Treatment Group B HFCC + Cough Assist Arm.
Participant milestones
| Measure |
Treatment Group A - HFCC Only
Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
|
Treatment Group B- HFCC and Cough Assist
Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
4
|
|
Overall Study
COMPLETED
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Use of Airway Clearance Devices in ALS
Baseline characteristics by cohort
| Measure |
Treatment Group A HFCC Only
n=1 Participants
Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
|
Treatment Group B HFCC + Cough Assist
n=4 Participants
Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
78 years
n=5 Participants
|
61.5 years
n=7 Participants
|
64.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Height
|
183 centimeters
n=5 Participants
|
173.25 centimeters
n=7 Participants
|
178.125 centimeters
n=5 Participants
|
|
Weight
|
87 kilograms
n=5 Participants
|
81.15 kilograms
n=7 Participants
|
84.075 kilograms
n=5 Participants
|
|
Forced Vital Capacity
|
43 % Predicted
n=5 Participants
|
64.25 % Predicted
n=7 Participants
|
53.625 % Predicted
n=5 Participants
|
|
Forced Expiratory Volume
|
53 % Predicted
n=5 Participants
|
67.5 % Predicted
n=7 Participants
|
60.25 % Predicted
n=5 Participants
|
|
Maximum Inspiratory Pressure (MIP)
|
59 cm/H20
n=5 Participants
|
72.25 cm/H20
n=7 Participants
|
65.625 cm/H20
n=5 Participants
|
|
Maximum Expiratory Pressure (MEP)
|
27 cm/H20
n=5 Participants
|
60 cm/H20
n=7 Participants
|
43.5 cm/H20
n=5 Participants
|
|
Diffusion Capacity
|
12.7 ml/mmHg/min
n=5 Participants
|
18.9 ml/mmHg/min
n=7 Participants
|
15.8 ml/mmHg/min
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 X-rays over 6 months.Population: Chest X-ray was not performed for Subject 003 of treatment group A at any visit and therefore was not analyzed. Chest X-ray was performed for Subjects 001, 002, 004, and 005. There was not found to be any improvement of respiratory symptoms across all participants. Not enough data to draw statistical inferences between groups.
A projection radiograph of the chest used to diagnose conditions affecting the chest. Chest X-Ray performed at each study visit. Investigator looked at clinical impression of Chest X-ray to be normal versus abnormal. If there was presence of atelectasis, this indicated a worsening of subject's respiratory symptoms. If subject's Chest X-Ray impression remained the same and continually normal, this indicated no change in respiratory symptoms.
Outcome measures
| Measure |
Treatment Group A
Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
|
Treatment Group B- HFCC and Cough Assist
n=4 Participants
Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.
|
|---|---|---|
|
Number of Subjects With Improved Respiratory Symptoms as Shown by Chest X-Ray Between Baseline and End of Study
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 lung ventilation scans over 6 months.Population: Lung scan was not performed for Subject 003 of treatment group A at any visit and therefore was not analyzed. Lung scan was performed for Subjects 001, 002, 004, and 005. There was not found to be any improvement of respiratory symptoms across all participants. Not enough data to draw statistical inferences between groups.
A nuclear scanning test commonly used to detect abnormalities in air flow. A radioactive tracer gas or mist is inhaled into the lungs. Pictures from the scan indicate areas of the lungs that are not receiving enough air or that retain too much air. Areas of the lung that retain too much air are brighter spots on the film and areas not receiving enough air are dark. Lung scan performed at each study visit. Investigator looked at clinical impression of lung scan to be normal versus abnormal. If there was indication of decreased ventilation, this indicated a worsening of subject's respiratory symptoms. If subject's lung scan impression remained the same and continually normal, this indicated no change in respiratory symptoms.
Outcome measures
| Measure |
Treatment Group A
Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
|
Treatment Group B- HFCC and Cough Assist
n=4 Participants
Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.
|
|---|---|---|
|
Number of Subjects With Improved Respiratory Symptoms As Shown By Lung Ventilation Scan Between Baseline and End of Study
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 questionnaires over 6 months.Population: Treatment Group A subject 003 did not complete study. Treatment Group B subjects 001 and 005 were only subjects to complete study and reported upward trend of McGill Quality of Life Scale. Not enough data to draw statistical inferences between groups.
Assess the improvement of/ rate of deterioration of the subject's quality of life from baseline to end of study on a rated scale of 1 to 10.
Outcome measures
| Measure |
Treatment Group A
Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
|
Treatment Group B- HFCC and Cough Assist
n=2 Participants
Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.
|
|---|---|---|
|
Number of Participants With Increased McGill Single Item Quality of Life Scale Question Between Baseline and End of Study
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 testing sessions over 6 months.Population: Treatment Group A subject 003 did not complete study. Treatment Group B subjects 001 and 005 were only subjects to complete study and there was a worsening of FVC values for both subjects. Not enough data to draw statistical inferences between groups.
Spirometry will be used to measure FVC. It is the most common of the pulmonary function tests and measures lung function, specifically the measurement of the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.
Outcome measures
| Measure |
Treatment Group A
Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
|
Treatment Group B- HFCC and Cough Assist
n=2 Participants
Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.
|
|---|---|---|
|
Number of Participants With Improved Forced Vital Capacity (FVC) Between Baseline and End of Study
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 testing sessions over 6 months.Population: Treatment Group A subject 003 did not complete study. Treatment Group B subjects 001 and 005 were only subjects to complete study and there was a worsening of MIP values for both subjects. Not enough data to draw statistical inferences between groups.
Spirometry will be used to measure MIP. It is the most common of the pulmonary function tests and measures lung function, specifically the measurement of the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.
Outcome measures
| Measure |
Treatment Group A
Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
|
Treatment Group B- HFCC and Cough Assist
n=2 Participants
Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.
|
|---|---|---|
|
Number of Participants With Improved Maximal Inspiratory Pressure (MIP) Between Baseline and End of Study
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 time at screening/baseline and then at the month 1, month 3, and month 6 study visit for a total of 4 testing sessions over 6 months.Population: Treatment Group A subject 003 did not complete study. Treatment Group B subjects 001 and 005 were only subjects to complete study and there was a worsening of diffusion capacity values for subject 005 and an improvement of subject 005 from 23.1 ml/mmHg/min to 28.7 ml/mmHg/min Not enough data to draw statistical inferences between groups.
Spirometry will be used to measure Diffusion Capacity. It is the most common of the pulmonary function tests and measures lung function, specifically the measurement of the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.
Outcome measures
| Measure |
Treatment Group A
Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
|
Treatment Group B- HFCC and Cough Assist
n=2 Participants
Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.
|
|---|---|---|
|
Number of Participants With Improved Diffusion Capacity Between Baseline and End of Study
|
0 Participants
|
1 Participants
|
Adverse Events
Treatment Group A - HFCC Only
Treatment Group B- HFCC and Cough Assist
Serious adverse events
| Measure |
Treatment Group A - HFCC Only
n=1 participants at risk
Subjects randomized to group A will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device for home use. Subjects will be instructed to use the HFCC device 2-3 times per day for 15-30 minutes each. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
|
Treatment Group B- HFCC and Cough Assist
n=4 participants at risk
Subjects randomized to group B will be fitted for and issued a mechanical High Frequency Chest Compression Device (HFCC) device and will also be issued a cough assist device. Subjects will be instructed in the use of both devices. The HFCC device should be utilized 2-3 times per day for 15-30 minutes each followed by a session with the cough assist. Subjects will be instructed to keep a device usage, concomitant medication, and adverse event diary.
High Frequency Chest Compression Device (HFCC): A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
Cough Assist: A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death due to respiratory insufficiency
|
100.0%
1/1 • Number of events 1 • 25.7 weeks
|
0.00%
0/4 • 25.7 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place