An interventional study of Oscillation and Lung Expansion (OLE) therapy in Neuromuscular Diseases, sponsored by Baxter Healthcare Corporation. Terminated at 1 site in United States. Open to participants aged 5 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Baxter Healthcare Corporation · Not applicable, Interventional, and Treatment
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.
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.
Patients who met all the following inclusion criteria are included in the study:
Patients who meet any of the following criteria will be excluded from the study:
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Device: Oscillation and Lung Expansion (OLE) therapy
Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
| Milestone | Intervention |
|---|---|
| Started | 39 |
| Completed | 33 |
| Not completed | 6 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Screen failure | 2 |
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
| Exacerbations | Intervention |
|---|---|
| 6 months pre-treatment | 1.0 ± 0.81 |
| Volara active treatment | 1.2 ± 1.39 |
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.
| Litres | Intervention |
|---|---|
| Baseline | 1.523 ± 0.7664 |
| 1 month | 1.609 ± 0.6891 |
| 2 months | 1.693 ± 0.6684 |
| 3 months | 1.741 ± 0.6763 |
| 4 months | 1.407 ± 0.6580 |
| 5 months | 1.498 ± 0.5858 |
| 6 months | 1.601 ± 0.4604 |
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.
| Litres per second | Intervention |
|---|---|
| Baseline | 2.121 ± 1.4399 |
| 1 month | 2.730 ± 1.3391 |
| 2 months | 2.595 ± 0.0778 |
| 3 months | 2.874 ± 0.6911 |
| 4 months | 3.297 ± 0.5543 |
| 5 months | 3.327 ± 0.9673 |
| 6 months | 2.153 ± 1.6887 |
Oxygen Saturation will be measured while the subject is resting using a hand-held oximeter.
| percentage oxygen saturation | Intervention |
|---|---|
| Baseline | 95.68 ± 1.978 |
| 1 month | 96.78 ± 1.986 |
| 2 months | 96.57 ± 2.699 |
| 3 months | 96.73 ± 1.794 |
| 4 months | 96.11 ± 2.759 |
| 5 months | 97.00 ± 2.000 |
| 6 months | 95.64 ± 3.641 |
Maximal Inspiratory Pressure is the maximum force (measured in centimeters of water \[cmH2O\]) that the subject can generate during an inspiratory effort.
| centimeters of water | Intervention |
|---|---|
| Baseline | -40.7 ± 16.56 |
| 1 month | -45.7 ± 16.18 |
| 2 months | -46.3 ± 17.86 |
| 3 months | -48.6 ± 16.81 |
| 4 months | -42.3 ± 18.29 |
| 5 months | -42.8 ± 21.91 |
| 6 months | -50.8 ± 12.81 |
Number of hospital admissions for respiratory complications.
| number of visits | Intervention |
|---|---|
| 6 months pre-treatment | 0.5 ± 0.67 |
| Volara active treatment | 0.4 ± 0.75 |
Number of inpatient hospital days for respiratory complications
| days | Intervention |
|---|---|
| 6 months pre-treatment | 5.2 ± 7.90 |
| Volara active treatment | 1.7 ± 3.19 |
Number of ICU admissions for respiratory complications.
| Number of visits | Intervention |
|---|---|
| 6 months pre-treatment | 0.2 ± 0.55 |
| Volara active treatment | 0.2 ± 0.53 |
Number of ICU hospital days for respiratory complications
| days | Intervention |
|---|---|
| 6 months pre-treatment | 1.9 ± 5.42 |
| Volara active treatment | 0.8 ± 2.41 |
Number of unscheduled Physician's office visits, urgent care visits, and emergency department (ED) visits.
| Number of visits | Intervention |
|---|---|
| 6 months pre-treatment | 0.7 ± 0.82 |
| Volara active treatment | 0.9 ± 1.20 |
The total number of antibiotic use days includes any of the following: intravenous (IV) antibiotic days, oral antibiotic days, and nebulized antibiotic days.
| Number of days | Intervention |
|---|---|
| 6 months pre-treatment | 6.6 ± 8.04 |
| Volara active treatment | 4.5 ± 7.57 |
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.
| minutes/day | Intervention |
|---|---|
| Adherence to Treatment Regimen: Average Daily Volara System Usage | 15.1 ± 13.7 |
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.
| Score on SRI scale | Intervention |
|---|---|
| Baseline | 45.654 ± 22.6888 |
| 1 month | 57.000 ± 21.0432 |
| 3 months | 59.953 ± 22.4735 |
| 6 months | 63.390 ± 21.2530 |
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.
| Participants | Intervention |
|---|---|
| Q1R1. It is so difficult to use the current airway clearance therapy that I do not want to use it | 0 |
| Q1R2. It is very difficult to use the current airway clearance therapy | 0 |
| Q1R3. It is moderately difficult to use the current airway clearance therapy | 7 |
| Q1R4. It is fairly easy to use the current airway clearance therapy | 14 |
| Q1R5. It is very easy to use the current airway clearance therapy | 5 |
| Q1R0. No answer on ease/difficulty of using the current airway clearance therapy | 7 |
| Q2R1. It is so difficult to tolerate the current airway clearance therapy that I don't want to do it | 0 |
| Q2R2. It is very difficult to tolerate the current airway clearance therapy | 1 |
| Q2R3. It is moderately difficult to tolerate the current airway clearance therapy | 6 |
| Q2R4. It is fairly easy to tolerate the current airway clearance therapy | 12 |
| Q2R5. It is very easy to tolerate the current airway clearance therapy | 6 |
| Q2R0. No answer on ease/difficulty of tolerating the current airway clearance therapy | 8 |
| Q3R1. I never miss therapy with the current airway clearance therapy | 12 |
| Q3R2. I miss therapy once a week | 7 |
| Q3R3. I miss therapy twice a week | 2 |
| Q3R4. I miss therapy three times a week | 3 |
| Q3R5. I miss therapy four or more times a week | 1 |
| Q3R0. No response on frequency of missing therapy per week | 8 |
| Q4R1. The current airway clearance is not effective as I never bring up sputum with therapy | 2 |
| Q4R2. The current airway clearance therapy is effective sometimes | 11 |
| Q4R3. The current airway clearance therapy is mostly effective | 6 |
| Q4R4. The current airway clearance therapy is almost always effective | 5 |
| Q4R5. I always bring up sputum with therapy | 2 |
| Q4R0. No answer on effectiveness of current airway clearance therapy on bringing up sputum | 7 |
| Q5R1. I always feel short of breath | 0 |
| Q5R2. I frequently have shortness of breath episodes | 2 |
| Q5R3. I have some shortness of breath episodes | 5 |
| Q5R4. I have a few shortness of breath episodes | 15 |
| Q5R5. I never have shortness of breath | 3 |
| Q5R0. No answer on effect of current airway clearance therapy on breathing | 8 |
| Q6R1. I do not feel the current airway clearance therapy helps my lungs stay healthy | 1 |
| Q6R2. I am unsure if this therapy helps my lungs stay healthy | 0 |
| Q6R3. This therapy seems somewhat helpful helpful for my lungs | 10 |
| Q6R4. I feel this therapy helps my lungs stay healthy | 10 |
| Q6R5. I definitely feel this therapy helps my lungs stay healthy | 4 |
| Q6R0. No answer on whether patients feel the current therapy helps their lungs feel healthy | 8 |
| Q7R1. My ability to perform daily tasks has definitely not improved | 1 |
| Q7R2. My ability to perform daily tasks has not improved | 2 |
| Q7R3. I am unsure if my ability to perform daily tasks has improved | 8 |
| Q7R4. I have had some improvement in ability to perform daily tasks | 13 |
| Q7R5. I have had significant improvement in ability to perform daily tasks | 1 |
| Q7R0. No answer on effect of current therapy on ability to perform daily tasks | 8 |
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.
| Participants | Intervention |
|---|---|
| Q1R1. It is so difficult to use the Volara System that I do not want to use it | 0 |
| Q1R2. It is very difficult to use the Volara System | 1 |
| Q1R3. It is moderately difficult to use the Volara System | 0 |
| Q1R4. It is fairly easy to use the Volara System | 15 |
| Q1R5. It is very easy to use the Volara System | 15 |
| Q1R0. No answer on ease/difficulty of using the Volara System | 2 |
| Q2R1. It is so difficult to tolerate therapy with the Volara System that I don't want to do it | 0 |
| Q2R2. It is very difficult to tolerate therapy with the Volara System | 2 |
| Q2R3. It is moderately difficult to tolerate therapy with the Volara System | 3 |
| Q2R4. It is fairly easy to tolerate therapy with the Volara System | 17 |
| Q2R5. It is very easy to tolerate therapy with the Volara System | 9 |
| Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System | 2 |
| Q3R1. I never miss therapy | 17 |
| Q3R2. I miss therapy once a week | 8 |
| Q3R3. I miss therapy twice a week | 1 |
| Q3R4. I miss therapy three times a week | 4 |
| Q3R5. I miss therapy four or more times a week | 0 |
| Q3R0. No response on frequency of missing therapy per week | 3 |
| Q4R1. The therapy is not effective as I never bring up sputum with therapy | 3 |
| Q4R2. The therapy is effective sometimes | 8 |
| Q4R3. The therapy is mostly effective | 11 |
| Q4R4. The therapy is almost always effective | 6 |
| Q4R5. I always bring up sputum with therapy | 3 |
| Q4R0. No answer on effectiveness of therapy in bringing up sputum | 2 |
| Q5R1. I always feel short of breath | 0 |
| Q5R2. I frequently have shortness of breath episodes | 0 |
| Q5R3. I have some shortness of breath episodes | 7 |
| Q5R4. I have a few shortness of breath episodes | 19 |
| Q5R5. I never have shortness of breath | 5 |
| Q5R0. No answer on effect of therapy on breathing | 2 |
| Q6R1. I do not feel the therapy helps my lungs stay healthy | 0 |
| Q6R2. I am unsure if this therapy helps my lungs stay healthy | 3 |
| Q6R3. This therapy seems somewhat helpful helpful for my lungs | 7 |
| Q6R4. I feel this therapy helps my lungs stay healthy | 15 |
| Q6R5. I definitely feel this therapy helps my lungs stay healthy | 5 |
| Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy | 3 |
| Q7R1. My ability to perform daily tasks has definitely not improved | 0 |
| Q7R2. My ability to perform daily tasks has not improved | 3 |
| Q7R3. I am unsure if my ability to perform daily tasks has improved | 14 |
| Q7R4. I have had some improvement in ability to perform daily tasks | 10 |
| Q7R5. I have had significant improvement in ability to perform daily tasks | 2 |
| Q7R0. No answer on effect of current therapy on ability to perform daily tasks | 4 |
| Q8R1. I do not want to continue. I strongly prefer to use my previous therapy | 0 |
| Q8R2. I prefer to use my previous therapy | 2 |
| Q8R3. I do not have a preference on which therapy I use | 3 |
| Q8R4. I prefer to continue to do therapy with the Volara System | 17 |
| Q8R5. I strongly prefer to continue to do therapy with the Volara System | 9 |
| Q8R0. No answer given on therapy preference | 2 |
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.
| Participants | Intervention |
|---|---|
| Q1R1. It is so difficult to use the Volara System that I do not want to use it | 0 |
| Q1R2. It is very difficult to use the Volara System | 0 |
| Q1R3. It is moderately difficult to use the Volara System | 1 |
| Q1R4. It is fairly easy to use the Volara System | 15 |
| Q1R5. It is very easy to use the Volara System | 13 |
| Q1R0. No answer on ease/difficulty of using the Volara System | 4 |
| Q2R1. It is so difficult to tolerate therapy with the Volara System that I don't want to do it | 0 |
| Q2R2. It is very difficult to tolerate therapy with the Volara System | 0 |
| Q2R3. It is moderately difficult to tolerate therapy with the Volara System | 4 |
| Q2R4. It is fairly easy to tolerate therapy with the Volara System | 15 |
| Q2R5. It is very easy to tolerate therapy with the Volara System | 10 |
| Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System | 4 |
| Q3R1. I never miss therapy | 14 |
| Q3R2. I miss therapy once a week | 12 |
| Q3R3. I miss therapy twice a week | 2 |
| Q3R4. I miss therapy three times a week | 1 |
| Q3R5. I miss therapy four or more times a week | 0 |
| Q3R0. No response on frequency of missing therapy per week | 4 |
| Q4R1. The therapy is not effective as I never bring up sputum with therapy | 2 |
| Q4R2. The therapy is effective sometimes | 9 |
| Q4R3. The therapy is mostly effective | 5 |
| Q4R4. The therapy is almost always effective | 9 |
| Q4R5. I always bring up sputum with therapy | 4 |
| Q4R0. No answer on effectiveness of therapy in bringing up sputum | 4 |
| Q5R1. I always feel short of breath | 0 |
| Q5R2. I frequently have shortness of breath episodes | 1 |
| Q5R3. I have some shortness of breath episodes | 3 |
| Q5R4. I have a few shortness of breath episodes | 14 |
| Q5R5. I never have shortness of breath | 10 |
| Q5R0. No answer on effect of therapy on breathing | 5 |
| Q6R1. I do not feel the therapy helps my lungs stay healthy | 1 |
| Q6R2. I am unsure if this therapy helps my lungs stay healthy | 2 |
| Q6R3. This therapy seems somewhat helpful helpful for my lungs | 7 |
| Q6R4. I feel this therapy helps my lungs stay healthy | 12 |
| Q6R5. I definitely feel this therapy helps my lungs stay healthy | 7 |
| Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy | 4 |
| Q7R1. My ability to perform daily tasks has definitely not improved | 0 |
| Q7R2. My ability to perform daily tasks has not improved | 1 |
| Q7R3. I am unsure if my ability to perform daily tasks has improved | 12 |
| Q7R4. I have had some improvement in ability to perform daily tasks | 11 |
| Q7R5. I have had significant improvement in ability to perform daily tasks | 1 |
| Q7R0. No answer on effect of current therapy on ability to perform daily tasks | 8 |
| Q8R1. I do not want to continue. I strongly prefer to use my previous therapy | 1 |
| Q8R2. I prefer to use my previous therapy | 1 |
| Q8R3. I do not have a preference on which therapy I use | 5 |
| Q8R4. I prefer to continue to do therapy with the Volara System | 14 |
| Q8R5. I strongly prefer to continue to do therapy with the Volara System | 8 |
| Q8R0. No answer given on therapy preference | 4 |
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.
| Participants | Intervention |
|---|---|
| Q1R1. It is so difficult to use the Volara System that I do not want to use it | 0 |
| Q1R2. It is very difficult to use the Volara System | 2 |
| Q1R3. It is moderately difficult to use the Volara System | 1 |
| Q1R4. It is fairly easy to use the Volara System | 13 |
| Q1R5. It is very easy to use the Volara System | 11 |
| Q1R0. No answer on ease/difficulty of using the Volara System | 6 |
| Q2R1. It is so difficult to tolerate therapy with the Volara System that I don't want to do it | 1 |
| Q2R2. It is very difficult to tolerate therapy with the Volara System | 2 |
| Q2R3. It is moderately difficult to tolerate therapy with the Volara System | 3 |
| Q2R4. It is fairly easy to tolerate therapy with the Volara System | 14 |
| Q2R5. It is very easy to tolerate therapy with the Volara System | 7 |
| Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System | 6 |
| Q3R1. I never miss therapy | 13 |
| Q3R2. I miss therapy once a week | 7 |
| Q3R3. I miss therapy twice a week | 2 |
| Q3R4. I miss therapy three times a week | 4 |
| Q3R5. I miss therapy four or more times a week | 1 |
| Q3R0. No response on frequency of missing therapy per week | 6 |
| Q4R1. The therapy is not effective as I never bring up sputum with therapy | 2 |
| Q4R2. The therapy is effective sometimes | 11 |
| Q4R3. The therapy is mostly effective | 7 |
| Q4R4. The therapy is almost always effective | 4 |
| Q4R5. I always bring up sputum with therapy | 3 |
| Q4R0. No answer on effectiveness of therapy in bringing up sputum | 6 |
| Q5R1. I always feel short of breath | 0 |
| Q5R2. I frequently have shortness of breath episodes | 2 |
| Q5R3. I have some shortness of breath episodes | 3 |
| Q5R4. I have a few shortness of breath episodes | 12 |
| Q5R5. I never have shortness of breath | 8 |
| Q5R0. No answer on effect of therapy on breathing | 8 |
| Q6R1. I do not feel the therapy helps my lungs stay healthy | 1 |
| Q6R2. I am unsure if this therapy helps my lungs stay healthy | 2 |
| Q6R3. This therapy seems somewhat helpful helpful for my lungs | 3 |
| Q6R4. I feel this therapy helps my lungs stay healthy | 13 |
| Q6R5. I definitely feel this therapy helps my lungs stay healthy | 8 |
| Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy | 6 |
| Q7R1. My ability to perform daily tasks has definitely not improved | 2 |
| Q7R2. My ability to perform daily tasks has not improved | 4 |
| Q7R3. I am unsure if my ability to perform daily tasks has improved | 7 |
| Q7R4. I have had some improvement in ability to perform daily tasks | 7 |
| Q7R5. I have had significant improvement in ability to perform daily tasks | 5 |
| Q7R0. No answer on effect of current therapy on ability to perform daily tasks | 8 |
| Q8R1. I do not want to continue. I strongly prefer to use my previous therapy | 3 |
| Q8R2. I prefer to use my previous therapy | 2 |
| Q8R3. I do not have a preference on which therapy I use | 2 |
| Q8R4. I prefer to continue to do therapy with the Volara System | 9 |
| Q8R5. I strongly prefer to continue to do therapy with the Volara System | 8 |
| Q8R0. No answer given on therapy preference | 9 |
Collected over Duration of participation for enrolled patients ranged from 16 days to 354 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 2/41 (4.9%) | 0/33 (0%) | 2/33 (6.1%) |
| Event | Intervention |
|---|---|
| SeizureNervous system disorders | 1/33 |
| HyperventilationRespiratory, thoracic and mediastinal disorders | 1/33 |
| Age, Continuous(years) | Intervention |
|---|---|
| Mean | 19.4 ± 15.94 |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 13 |
| Male | 20 |
| Ethnicity (NIH/OMB)(Participants) | Intervention |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 5 |
| White | 19 |
| More than one race | 2 |
| Unknown or Not Reported | 5 |
| Region of Enrollment(participants) | Intervention |
|---|---|
| United States | 33 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Baxter Healthcare Corporation