Trial Outcomes & Findings for ALS and Airway Clearance (ALSAC) Therapy (NCT NCT04947436)

Last Updated: 2021-11-04

Results Overview

A 9-item instrument will be used to record change from baseline to 6 months in respiratory complications. These are scored on a scale from best (no complications) to worst (death due to respiratory complications) throughout the study period. Scores range from 0-9 with a score of a 9 indicating no complications.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2021-11-04

Participant Flow

Patients and their caregivers (PAC) were randomized into one of three groups. The PAC completed perception of problem and quality of life surveys.

Participant milestones

Participant milestones
Measure	High Frequency Chest Wall Oscillation High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.	Mechanical Insufflation/ Exsufflation Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.	High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx. Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.
Overall Study STARTED	7	10	11
Overall Study COMPLETED	3	2	5
Overall Study NOT COMPLETED	4	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	High Frequency Chest Wall Oscillation High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.	Mechanical Insufflation/ Exsufflation Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.	High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx. Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.
Overall Study Lost to Follow-up	3	7	5
Overall Study Death	1	1	1

Baseline Characteristics

ALS and Airway Clearance (ALSAC) Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Frequency Chest Wall Oscillation n=7 Participants High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.	High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation n=11 Participants High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx. Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.	Mechanical Insufflation/ Exsufflation n=10 Participants Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic-Non White	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Half (50%) of patients were randomized to the group with two devices, while 30% to only the HFCWO device and 20% to only the Mechanical Insufflation/exsufflation device.

Outcome measures

Outcome measures
Measure	High Frequency Chest Wall Oscillation n=3 Participants High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.	Mechanical Insufflation/ Exsufflation n=2 Participants Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.	High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation n=5 Participants High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx. Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.
Respiratory Complications Severity	8.33 score on a scale Standard Deviation 1.15	9.0 score on a scale Standard Deviation 0	7.8 score on a scale Standard Deviation 1.64

SECONDARY outcome

Timeframe: Baseline to 6 months

This outcome is assessed and recorded as a number from 1-5 with 1 indicating the worst outcome (markedly worse) and 5 indicating best outcome (markedly better) since starting the study.

Outcome measures

Outcome measures
Measure	High Frequency Chest Wall Oscillation n=3 Participants High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.	Mechanical Insufflation/ Exsufflation n=2 Participants Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.	High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation n=5 Participants High Frequency Chest Wall Oscillation: The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx. Mechanical insufflation/exsufflation: A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.
Patient Global Impression of Change (PGIC)	3.33 score on a scale Standard Deviation 0.58	3.00 score on a scale Standard Deviation 0	4.40 score on a scale Standard Deviation 0.96

Adverse Events

High Frequency Chest Wall Oscillation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Mechanical Insufflation/ Exsufflation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Donna Gardner

University of Texas Health San Antonio

Phone: 210-450-8479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place