Neuromuscular Diseases
Conditions
Brief summary
The study will be a non-randomized open label pilot study comparing a retrospective control period to an active treatment period with oscillation and lung expansion (OLE) therapy.
Detailed description
The study is a decentralized trial. All data will be collected in the patients' homes. The primary objective of the study is to evaluate the impact of OLE to treat respiratory complications of neuromuscular disease patients. The frequency of pulmonary exacerbations and other clinical outcome measures will be assessed to determine the effect of consistent OLE therapy.
Interventions
DEVICEOscillation and Lung Expansion (OLE) therapy
Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
Sponsors
Science 37
Baxter Healthcare Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study subjects will serve as their own control. Medical records will be reviewed for each study subject for the twelve-month period prior to initiation of OLE therapy. The study will compare the frequency of exacerbations experienced prior to treatment with OLE to the frequency of exacerbations experienced in the active treatment period, during which study subjects receive treatment with The Volara® System. In addition, specific healthcare utilization indicators including hospitalizations, antibiotic use, and emergency department (ED) visits for pulmonary complications will be documented for each study period.
Eligibility
Sex/Gender
ALL
Age
5 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients who met all the following inclusion criteria are included in the study: * Documented diagnosis of neuromuscular disease (NMD) or neurological disorder. * Age 5 to 80 years. * History of one or more respiratory exacerbations in the past 6 months or two or more respiratory exacerbations in the past 12 months, which required unplanned or unscheduled medical intervention. * Ability to perform Oscillation and Lung Expansion (OLE) therapy as directed. * Signed informed consent (and assent if minor patient). Patients who meet any of the following criteria will be excluded from the study: * Diagnosis with rapidly progressing NMD such as certain types of Motor Neuron Disease (MND). * Requirement for continuous mechanical ventilation. * Anticipated requirement for respiratory related hospitalization within the next six months. * History of pneumothorax within the past 6 months. * History of hemoptysis requiring embolization within past 12 months. * Pregnancy. * Home use of OLE therapy within the past 12 months. * Inability or unwillingness to perform OLE therapy or study procedures as required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention | 6 months pre-treatment and 6 months post-treatment with the Volara System | Exacerbation of pulmonary disease is a worsening of pulmonary condition or an event requiring one or more of the following: * Hospitalization * Emergency Department visit * Unscheduled antibiotics * Unscheduled outpatient visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Cough Flow | Baseline and monthly for 6 months | Peak Cough Flow is a pulmonary function measure that evaluates maximum peak flow generated during a cough maneuver. It will be measured with a hand-held spirometer. |
| Resting Oxygen Saturation | Baseline and monthly for 6 months | Oxygen Saturation will be measured while the subject is resting using a hand-held oximeter. |
| Maximal Inspiratory Pressure | Baseline and monthly for 6 months | Maximal Inspiratory Pressure is the maximum force (measured in centimeters of water \[cmH2O\]) that the subject can generate during an inspiratory effort. |
| Number of Hospital Admissions | 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System | Number of hospital admissions for respiratory complications. |
| Total Hospital Length of Stay | 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System | Number of inpatient hospital days for respiratory complications |
| Number of Intensive Care Unit (ICU) Admissions | 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System | Number of ICU admissions for respiratory complications. |
| Total Intensive Care Unit (ICU) Length of Stay | 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System | Number of ICU hospital days for respiratory complications |
| Slow Vital Capacity | Baseline and monthly for 6 months | Slow Vital Capacity is the maximum volume that the subject can exhale in a single breath, following full inspiration. The measure is taken using a slow consistent exhalation. |
| Total Number of Antibiotic Use Days During Episodes for Respiratory Infection | 6 months pre-treatment and 6 months post-treatment with the Volara System | The total number of antibiotic use days includes any of the following: intravenous (IV) antibiotic days, oral antibiotic days, and nebulized antibiotic days. |
| Adherence to Treatment Regimen: Average Daily Volara System Usage | Total number of days the subject had the device (approximately up to 6 months of OLE therapy) | Adherence to the OLE treatment regimen was presented as Average Daily Volara System Usage. This was calculated by dividing the total minutes of device use by the total number of days the subject had the device. |
| Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire | Baseline, and after 1 month, 3 months, and 6 months of therapy using the Volara System | Severe Respiratory Insufficiency (SRI) questionnaire administered at baseline, and at 1, 3 and 6 months. The total score can range from a minimum of 0 to a maximum of 100 with higher values indicating a better health-related quality of life according to content of the scale. |
| Satisfaction With Current Airway Clearance Therapy at Baseline | Baseline | Satisfaction is assessed through a questionnaire administered at baseline. Seven satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 35, with 35 indicating the highest satisfaction. |
| Satisfaction With OLE Therapy After 1 Month of Using the Volara System | After 1 month of using the Volara System | Satisfaction is assessed through a questionnaire administered after 1 month of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction. |
| Satisfaction With OLE Therapy After 3 Months of Using the Volara System | After 3 months of using the Volara System | Satisfaction is assessed through a questionnaire administered after 3 months of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction. |
| Satisfaction With OLE Therapy After 6 Months of Using the Volara System | After 6 months of using the Volara System | Satisfaction is assessed through a questionnaire administered after 6 months of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction. |
| Number of Outpatient Visits for Pulmonary Complications | 6 months pre-treatment and 6 months post-treatment with the Volara System | Number of unscheduled Physician's office visits, urgent care visits, and emergency department (ED) visits. |
Countries
United States
Participant flow
Pre-assignment details
Retrospective data was collected from a total of 41 patients. Two patients died prior to study start. Thus, these two patients were excluded from any safety analyses as they had no exposure to the Volara System.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Oscillation and Lung Expansion (OLE) therapy: Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Screen Failure | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 19.4 years STANDARD_DEVIATION 15.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 41 |
| other Total, other adverse events | 2 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention
Exacerbation of pulmonary disease is a worsening of pulmonary condition or an event requiring one or more of the following: * Hospitalization * Emergency Department visit * Unscheduled antibiotics * Unscheduled outpatient visit
Time frame: 6 months pre-treatment and 6 months post-treatment with the Volara System
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention | 6 months pre-treatment | 1.0 Exacerbations | Standard Deviation 0.81 |
| Intervention | Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention | Volara active treatment | 1.2 Exacerbations | Standard Deviation 1.39 |
Secondary
Adherence to Treatment Regimen: Average Daily Volara System Usage
Adherence to the OLE treatment regimen was presented as Average Daily Volara System Usage. This was calculated by dividing the total minutes of device use by the total number of days the subject had the device.
Time frame: Total number of days the subject had the device (approximately up to 6 months of OLE therapy)
Population: Device usage information was only available for 18 of the 33 subjects as the remaining subjects did not return the Volara System. Some subjects retained the device beyond the 6-month active treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Adherence to Treatment Regimen: Average Daily Volara System Usage | 15.1 minutes/day | Standard Deviation 13.7 |
Secondary
Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire
Severe Respiratory Insufficiency (SRI) questionnaire administered at baseline, and at 1, 3 and 6 months. The total score can range from a minimum of 0 to a maximum of 100 with higher values indicating a better health-related quality of life according to content of the scale.
Time frame: Baseline, and after 1 month, 3 months, and 6 months of therapy using the Volara System
Population: All responses obtained are presented. Some patients did not provide feedback at certain follow-up visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire | Baseline | 45.654 Score on SRI scale | Standard Deviation 22.6888 |
| Intervention | Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire | 1 month | 57.000 Score on SRI scale | Standard Deviation 21.0432 |
| Intervention | Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire | 3 months | 59.953 Score on SRI scale | Standard Deviation 22.4735 |
| Intervention | Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire | 6 months | 63.390 Score on SRI scale | Standard Deviation 21.253 |
Secondary
Maximal Inspiratory Pressure
Maximal Inspiratory Pressure is the maximum force (measured in centimeters of water \[cmH2O\]) that the subject can generate during an inspiratory effort.
Time frame: Baseline and monthly for 6 months
Population: Pulmonary Function Tests were analyzed for the Full Analysis Set (N=33). Of the Full Analysis Set, 11 subjects had data available for Maximal Inspiratory Pressure. The number of participants analyzed at each timepoint reflects the patients who were strong enough and had coordination to have this measurement taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Maximal Inspiratory Pressure | Baseline | -40.7 centimeters of water | Standard Deviation 16.56 |
| Intervention | Maximal Inspiratory Pressure | 1 month | -45.7 centimeters of water | Standard Deviation 16.18 |
| Intervention | Maximal Inspiratory Pressure | 2 months | -46.3 centimeters of water | Standard Deviation 17.86 |
| Intervention | Maximal Inspiratory Pressure | 3 months | -48.6 centimeters of water | Standard Deviation 16.81 |
| Intervention | Maximal Inspiratory Pressure | 4 months | -42.3 centimeters of water | Standard Deviation 18.29 |
| Intervention | Maximal Inspiratory Pressure | 5 months | -42.8 centimeters of water | Standard Deviation 21.91 |
| Intervention | Maximal Inspiratory Pressure | 6 months | -50.8 centimeters of water | Standard Deviation 12.81 |
Secondary
Number of Hospital Admissions
Number of hospital admissions for respiratory complications.
Time frame: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Number of Hospital Admissions | 6 months pre-treatment | 0.5 number of visits | Standard Deviation 0.67 |
| Intervention | Number of Hospital Admissions | Volara active treatment | 0.4 number of visits | Standard Deviation 0.75 |
Secondary
Number of Intensive Care Unit (ICU) Admissions
Number of ICU admissions for respiratory complications.
Time frame: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Number of Intensive Care Unit (ICU) Admissions | 6 months pre-treatment | 0.2 Number of visits | Standard Deviation 0.55 |
| Intervention | Number of Intensive Care Unit (ICU) Admissions | Volara active treatment | 0.2 Number of visits | Standard Deviation 0.53 |
Secondary
Number of Outpatient Visits for Pulmonary Complications
Number of unscheduled Physician's office visits, urgent care visits, and emergency department (ED) visits.
Time frame: 6 months pre-treatment and 6 months post-treatment with the Volara System
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Number of Outpatient Visits for Pulmonary Complications | 6 months pre-treatment | 0.7 Number of visits | Standard Deviation 0.82 |
| Intervention | Number of Outpatient Visits for Pulmonary Complications | Volara active treatment | 0.9 Number of visits | Standard Deviation 1.2 |
Secondary
Peak Cough Flow
Peak Cough Flow is a pulmonary function measure that evaluates maximum peak flow generated during a cough maneuver. It will be measured with a hand-held spirometer.
Time frame: Baseline and monthly for 6 months
Population: Pulmonary Function Tests were analyzed for the Full Analysis Set (N=33). Of the Full Analysis Set, 10 subjects had data available for Peak Cough Flow. The number of participants analyzed at each timepoint reflects the patients who were strong enough and had coordination to have this measurement taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Peak Cough Flow | 5 months | 3.327 Litres per second | Standard Deviation 0.9673 |
| Intervention | Peak Cough Flow | 6 months | 2.153 Litres per second | Standard Deviation 1.6887 |
| Intervention | Peak Cough Flow | Baseline | 2.121 Litres per second | Standard Deviation 1.4399 |
| Intervention | Peak Cough Flow | 1 month | 2.730 Litres per second | Standard Deviation 1.3391 |
| Intervention | Peak Cough Flow | 2 months | 2.595 Litres per second | Standard Deviation 0.0778 |
| Intervention | Peak Cough Flow | 3 months | 2.874 Litres per second | Standard Deviation 0.6911 |
| Intervention | Peak Cough Flow | 4 months | 3.297 Litres per second | Standard Deviation 0.5543 |
Secondary
Resting Oxygen Saturation
Oxygen Saturation will be measured while the subject is resting using a hand-held oximeter.
Time frame: Baseline and monthly for 6 months
Population: Pulmonary Function Tests were analyzed for the Full Analysis Set (N=33). Of the Full Analysis Set, 22 subjects had data available for Resting Oxygen Saturation. The number of participants analyzed at each timepoint reflects the patients who were strong enough and had coordination to have this measurement taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Resting Oxygen Saturation | 5 months | 97.00 percentage oxygen saturation | Standard Deviation 2 |
| Intervention | Resting Oxygen Saturation | 6 months | 95.64 percentage oxygen saturation | Standard Deviation 3.641 |
| Intervention | Resting Oxygen Saturation | Baseline | 95.68 percentage oxygen saturation | Standard Deviation 1.978 |
| Intervention | Resting Oxygen Saturation | 1 month | 96.78 percentage oxygen saturation | Standard Deviation 1.986 |
| Intervention | Resting Oxygen Saturation | 2 months | 96.57 percentage oxygen saturation | Standard Deviation 2.699 |
| Intervention | Resting Oxygen Saturation | 3 months | 96.73 percentage oxygen saturation | Standard Deviation 1.794 |
| Intervention | Resting Oxygen Saturation | 4 months | 96.11 percentage oxygen saturation | Standard Deviation 2.759 |
Secondary
Satisfaction With Current Airway Clearance Therapy at Baseline
Satisfaction is assessed through a questionnaire administered at baseline. Seven satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 35, with 35 indicating the highest satisfaction.
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q1R2. It is very difficult to use the current airway clearance therapy | 0 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q1R3. It is moderately difficult to use the current airway clearance therapy | 7 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q1R0. No answer on ease/difficulty of using the current airway clearance therapy | 7 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q2R1. It is so difficult to tolerate the current airway clearance therapy that I don't want to do it | 0 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q5R4. I have a few shortness of breath episodes | 15 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q5R5. I never have shortness of breath | 3 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q5R0. No answer on effect of current airway clearance therapy on breathing | 8 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q6R1. I do not feel the current airway clearance therapy helps my lungs stay healthy | 1 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q1R1. It is so difficult to use the current airway clearance therapy that I do not want to use it | 0 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q1R4. It is fairly easy to use the current airway clearance therapy | 14 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q1R5. It is very easy to use the current airway clearance therapy | 5 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q2R2. It is very difficult to tolerate the current airway clearance therapy | 1 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q2R3. It is moderately difficult to tolerate the current airway clearance therapy | 6 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q2R4. It is fairly easy to tolerate the current airway clearance therapy | 12 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q2R5. It is very easy to tolerate the current airway clearance therapy | 6 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q2R0. No answer on ease/difficulty of tolerating the current airway clearance therapy | 8 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q3R1. I never miss therapy with the current airway clearance therapy | 12 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q3R2. I miss therapy once a week | 7 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q3R3. I miss therapy twice a week | 2 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q3R4. I miss therapy three times a week | 3 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q3R5. I miss therapy four or more times a week | 1 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q3R0. No response on frequency of missing therapy per week | 8 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q4R1. The current airway clearance is not effective as I never bring up sputum with therapy | 2 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q4R2. The current airway clearance therapy is effective sometimes | 11 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q4R3. The current airway clearance therapy is mostly effective | 6 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q4R4. The current airway clearance therapy is almost always effective | 5 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q4R5. I always bring up sputum with therapy | 2 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q4R0. No answer on effectiveness of current airway clearance therapy on bringing up sputum | 7 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q5R1. I always feel short of breath | 0 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q5R2. I frequently have shortness of breath episodes | 2 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q5R3. I have some shortness of breath episodes | 5 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q6R2. I am unsure if this therapy helps my lungs stay healthy | 0 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q6R3. This therapy seems somewhat helpful helpful for my lungs | 10 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q6R4. I feel this therapy helps my lungs stay healthy | 10 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q6R5. I definitely feel this therapy helps my lungs stay healthy | 4 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q6R0. No answer on whether patients feel the current therapy helps their lungs feel healthy | 8 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q7R1. My ability to perform daily tasks has definitely not improved | 1 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q7R2. My ability to perform daily tasks has not improved | 2 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q7R3. I am unsure if my ability to perform daily tasks has improved | 8 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q7R4. I have had some improvement in ability to perform daily tasks | 13 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q7R5. I have had significant improvement in ability to perform daily tasks | 1 Participants |
| Intervention | Satisfaction With Current Airway Clearance Therapy at Baseline | Q7R0. No answer on effect of current therapy on ability to perform daily tasks | 8 Participants |
Secondary
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Satisfaction is assessed through a questionnaire administered after 1 month of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction.
Time frame: After 1 month of using the Volara System
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q2R5. It is very easy to tolerate therapy with the Volara System | 9 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q3R4. I miss therapy three times a week | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q5R2. I frequently have shortness of breath episodes | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q8R2. I prefer to use my previous therapy | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q8R4. I prefer to continue to do therapy with the Volara System | 17 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q1R0. No answer on ease/difficulty of using the Volara System | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q1R1. It is so difficult to use the Volara System that I do not want to use it | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q1R2. It is very difficult to use the Volara System | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q1R3. It is moderately difficult to use the Volara System | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q1R4. It is fairly easy to use the Volara System | 15 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q1R5. It is very easy to use the Volara System | 15 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q2R1. It is so difficult to tolerate therapy with the Volara System that I don't want to do it | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q2R2. It is very difficult to tolerate therapy with the Volara System | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q2R3. It is moderately difficult to tolerate therapy with the Volara System | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q2R4. It is fairly easy to tolerate therapy with the Volara System | 17 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q3R1. I never miss therapy | 17 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q3R2. I miss therapy once a week | 8 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q3R3. I miss therapy twice a week | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q3R5. I miss therapy four or more times a week | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q3R0. No response on frequency of missing therapy per week | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q4R1. The therapy is not effective as I never bring up sputum with therapy | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q4R2. The therapy is effective sometimes | 8 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q4R3. The therapy is mostly effective | 11 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q4R4. The therapy is almost always effective | 6 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q4R5. I always bring up sputum with therapy | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q4R0. No answer on effectiveness of therapy in bringing up sputum | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q5R1. I always feel short of breath | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q5R3. I have some shortness of breath episodes | 7 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q5R4. I have a few shortness of breath episodes | 19 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q5R5. I never have shortness of breath | 5 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q5R0. No answer on effect of therapy on breathing | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q6R1. I do not feel the therapy helps my lungs stay healthy | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q6R2. I am unsure if this therapy helps my lungs stay healthy | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q6R3. This therapy seems somewhat helpful helpful for my lungs | 7 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q6R4. I feel this therapy helps my lungs stay healthy | 15 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q6R5. I definitely feel this therapy helps my lungs stay healthy | 5 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q7R1. My ability to perform daily tasks has definitely not improved | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q7R2. My ability to perform daily tasks has not improved | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q7R3. I am unsure if my ability to perform daily tasks has improved | 14 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q7R4. I have had some improvement in ability to perform daily tasks | 10 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q7R5. I have had significant improvement in ability to perform daily tasks | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q7R0. No answer on effect of current therapy on ability to perform daily tasks | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q8R1. I do not want to continue. I strongly prefer to use my previous therapy | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q8R3. I do not have a preference on which therapy I use | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q8R5. I strongly prefer to continue to do therapy with the Volara System | 9 Participants |
| Intervention | Satisfaction With OLE Therapy After 1 Month of Using the Volara System | Q8R0. No answer given on therapy preference | 2 Participants |
Secondary
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Satisfaction is assessed through a questionnaire administered after 3 months of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction.
Time frame: After 3 months of using the Volara System
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q1R1. It is so difficult to use the Volara System that I do not want to use it | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q1R5. It is very easy to use the Volara System | 13 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q1R0. No answer on ease/difficulty of using the Volara System | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q3R4. I miss therapy three times a week | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q3R5. I miss therapy four or more times a week | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q7R2. My ability to perform daily tasks has not improved | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q4R5. I always bring up sputum with therapy | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q4R0. No answer on effectiveness of therapy in bringing up sputum | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q5R1. I always feel short of breath | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q5R2. I frequently have shortness of breath episodes | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q5R3. I have some shortness of breath episodes | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q5R4. I have a few shortness of breath episodes | 14 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q5R5. I never have shortness of breath | 10 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q5R0. No answer on effect of therapy on breathing | 5 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q6R1. I do not feel the therapy helps my lungs stay healthy | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q6R2. I am unsure if this therapy helps my lungs stay healthy | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q6R3. This therapy seems somewhat helpful helpful for my lungs | 7 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q6R4. I feel this therapy helps my lungs stay healthy | 12 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q6R5. I definitely feel this therapy helps my lungs stay healthy | 7 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q7R1. My ability to perform daily tasks has definitely not improved | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q7R3. I am unsure if my ability to perform daily tasks has improved | 12 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q7R4. I have had some improvement in ability to perform daily tasks | 11 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q7R5. I have had significant improvement in ability to perform daily tasks | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q7R0. No answer on effect of current therapy on ability to perform daily tasks | 8 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q8R1. I do not want to continue. I strongly prefer to use my previous therapy | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q8R2. I prefer to use my previous therapy | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q8R3. I do not have a preference on which therapy I use | 5 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q8R4. I prefer to continue to do therapy with the Volara System | 14 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q8R5. I strongly prefer to continue to do therapy with the Volara System | 8 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q8R0. No answer given on therapy preference | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q3R2. I miss therapy once a week | 12 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q1R2. It is very difficult to use the Volara System | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q1R3. It is moderately difficult to use the Volara System | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q1R4. It is fairly easy to use the Volara System | 15 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q2R1. It is so difficult to tolerate therapy with the Volara System that I don't want to do it | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q2R2. It is very difficult to tolerate therapy with the Volara System | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q2R3. It is moderately difficult to tolerate therapy with the Volara System | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q2R4. It is fairly easy to tolerate therapy with the Volara System | 15 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q2R5. It is very easy to tolerate therapy with the Volara System | 10 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q3R1. I never miss therapy | 14 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q3R3. I miss therapy twice a week | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q3R0. No response on frequency of missing therapy per week | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q4R1. The therapy is not effective as I never bring up sputum with therapy | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q4R2. The therapy is effective sometimes | 9 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q4R3. The therapy is mostly effective | 5 Participants |
| Intervention | Satisfaction With OLE Therapy After 3 Months of Using the Volara System | Q4R4. The therapy is almost always effective | 9 Participants |
Secondary
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Satisfaction is assessed through a questionnaire administered after 6 months of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction.
Time frame: After 6 months of using the Volara System
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q2R5. It is very easy to tolerate therapy with the Volara System | 7 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q1R1. It is so difficult to use the Volara System that I do not want to use it | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q1R2. It is very difficult to use the Volara System | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q1R3. It is moderately difficult to use the Volara System | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q1R4. It is fairly easy to use the Volara System | 13 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q1R5. It is very easy to use the Volara System | 11 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q1R0. No answer on ease/difficulty of using the Volara System | 6 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q2R1. It is so difficult to tolerate therapy with the Volara System that I don't want to do it | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q2R2. It is very difficult to tolerate therapy with the Volara System | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q2R3. It is moderately difficult to tolerate therapy with the Volara System | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q2R4. It is fairly easy to tolerate therapy with the Volara System | 14 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System | 6 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q3R1. I never miss therapy | 13 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q3R2. I miss therapy once a week | 7 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q3R3. I miss therapy twice a week | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q3R4. I miss therapy three times a week | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q3R5. I miss therapy four or more times a week | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q3R0. No response on frequency of missing therapy per week | 6 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q4R1. The therapy is not effective as I never bring up sputum with therapy | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q4R2. The therapy is effective sometimes | 11 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q4R3. The therapy is mostly effective | 7 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q4R4. The therapy is almost always effective | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q4R5. I always bring up sputum with therapy | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q4R0. No answer on effectiveness of therapy in bringing up sputum | 6 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q5R1. I always feel short of breath | 0 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q5R2. I frequently have shortness of breath episodes | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q5R3. I have some shortness of breath episodes | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q5R4. I have a few shortness of breath episodes | 12 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q5R5. I never have shortness of breath | 8 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q5R0. No answer on effect of therapy on breathing | 8 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q6R1. I do not feel the therapy helps my lungs stay healthy | 1 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q6R2. I am unsure if this therapy helps my lungs stay healthy | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q6R3. This therapy seems somewhat helpful helpful for my lungs | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q6R4. I feel this therapy helps my lungs stay healthy | 13 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q6R5. I definitely feel this therapy helps my lungs stay healthy | 8 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy | 6 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q7R1. My ability to perform daily tasks has definitely not improved | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q7R2. My ability to perform daily tasks has not improved | 4 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q7R3. I am unsure if my ability to perform daily tasks has improved | 7 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q7R4. I have had some improvement in ability to perform daily tasks | 7 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q7R5. I have had significant improvement in ability to perform daily tasks | 5 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q7R0. No answer on effect of current therapy on ability to perform daily tasks | 8 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q8R1. I do not want to continue. I strongly prefer to use my previous therapy | 3 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q8R2. I prefer to use my previous therapy | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q8R3. I do not have a preference on which therapy I use | 2 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q8R4. I prefer to continue to do therapy with the Volara System | 9 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q8R5. I strongly prefer to continue to do therapy with the Volara System | 8 Participants |
| Intervention | Satisfaction With OLE Therapy After 6 Months of Using the Volara System | Q8R0. No answer given on therapy preference | 9 Participants |
Secondary
Slow Vital Capacity
Slow Vital Capacity is the maximum volume that the subject can exhale in a single breath, following full inspiration. The measure is taken using a slow consistent exhalation.
Time frame: Baseline and monthly for 6 months
Population: Pulmonary Function Tests were analyzed for the Full Analysis Set (N=33). Of the Full Analysis Set, 12 subjects had data available for Slow Vital Capacity. The number of participants analyzed at each timepoint reflects the patients who were strong enough and had coordination to have this measurement taken.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Slow Vital Capacity | 5 months | 1.498 Litres | Standard Deviation 0.5858 |
| Intervention | Slow Vital Capacity | 6 months | 1.601 Litres | Standard Deviation 0.4604 |
| Intervention | Slow Vital Capacity | Baseline | 1.523 Litres | Standard Deviation 0.7664 |
| Intervention | Slow Vital Capacity | 1 month | 1.609 Litres | Standard Deviation 0.6891 |
| Intervention | Slow Vital Capacity | 2 months | 1.693 Litres | Standard Deviation 0.6684 |
| Intervention | Slow Vital Capacity | 3 months | 1.741 Litres | Standard Deviation 0.6763 |
| Intervention | Slow Vital Capacity | 4 months | 1.407 Litres | Standard Deviation 0.658 |
Secondary
Total Hospital Length of Stay
Number of inpatient hospital days for respiratory complications
Time frame: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Total Hospital Length of Stay | 6 months pre-treatment | 5.2 days | Standard Deviation 7.9 |
| Intervention | Total Hospital Length of Stay | Volara active treatment | 1.7 days | Standard Deviation 3.19 |
Secondary
Total Intensive Care Unit (ICU) Length of Stay
Number of ICU hospital days for respiratory complications
Time frame: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Total Intensive Care Unit (ICU) Length of Stay | 6 months pre-treatment | 1.9 days | Standard Deviation 5.42 |
| Intervention | Total Intensive Care Unit (ICU) Length of Stay | Volara active treatment | 0.8 days | Standard Deviation 2.41 |
Secondary
Total Number of Antibiotic Use Days During Episodes for Respiratory Infection
The total number of antibiotic use days includes any of the following: intravenous (IV) antibiotic days, oral antibiotic days, and nebulized antibiotic days.
Time frame: 6 months pre-treatment and 6 months post-treatment with the Volara System
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Total Number of Antibiotic Use Days During Episodes for Respiratory Infection | 6 months pre-treatment | 6.6 Number of days | Standard Deviation 8.04 |
| Intervention | Total Number of Antibiotic Use Days During Episodes for Respiratory Infection | Volara active treatment | 4.5 Number of days | Standard Deviation 7.57 |