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Slow enrollment
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| Name | Class |
|---|---|
| Science 37 | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oscillation and Lung Expansion (OLE) therapy | Device | Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 6 months pre-treatment and 6 months post-treatment with the Volara System |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and monthly for 6 months |
| Peak Cough Flow |
Not provided
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Science 37 | Durham | North Carolina | 27709 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Posted | Mean | Standard Deviation | Exacerbations | 6 months pre-treatment and 6 months post-treatment with the Volara System |
|
Duration of participation for enrolled patients ranged from 16 days to 354 days.
All-Cause Mortality was assessed in all enrolled patients. Adverse events were assessed for the patients who received treatment using the Volara System.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | MedDRA (27.0) | Non-systematic Assessment |
It may be that only the first pulmonary exacerbation in the 6 months before using Volara was recorded for patient enrollment.
Early termination led to a small number of patients being analyzed. Some patients were unable to undergo all planned analyses, such as Pulmonary Function Tests.
Selected patient population was broad in age and disease implying variability in disease trajectory and/or severity at enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Baxter Clinical Trials Disclosure Call Center | Baxter Healthcare | (224) 948-7359 | Global_CORP_ClinicalTrialsDisclosure@baxter.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2022 | Feb 24, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2024 | Feb 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
Not provided
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
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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.
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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.
| Baseline and monthly for 6 months |
| Resting Oxygen Saturation | Oxygen Saturation will be measured while the subject is resting using a hand-held oximeter. | 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. | Baseline and monthly for 6 months |
| Number of Hospital Admissions | Number of hospital admissions for respiratory complications. | 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 | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | After 6 months of using the Volara System |
| Screen Failure |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Litres | Baseline and monthly for 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Litres per second | Baseline and monthly for 6 months |
|
|
|
| Secondary | Resting Oxygen Saturation | Oxygen Saturation will be measured while the subject is resting using a hand-held oximeter. | 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. | Posted | Mean | Standard Deviation | percentage oxygen saturation | Baseline and monthly for 6 months |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | centimeters of water | Baseline and monthly for 6 months |
|
|
|
| Secondary | Number of Hospital Admissions | Number of hospital admissions for respiratory complications. | Posted | Mean | Standard Deviation | number of visits | 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System |
|
|
|
| Secondary | Total Hospital Length of Stay | Number of inpatient hospital days for respiratory complications | Posted | Mean | Standard Deviation | days | 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System |
|
|
|
| Secondary | Number of Intensive Care Unit (ICU) Admissions | Number of ICU admissions for respiratory complications. | Posted | Mean | Standard Deviation | Number of visits | 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System |
|
|
|
| Secondary | Total Intensive Care Unit (ICU) Length of Stay | Number of ICU hospital days for respiratory complications | Posted | Mean | Standard Deviation | days | 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System |
|
|
|
| Secondary | Number of Outpatient Visits for Pulmonary Complications | Number of unscheduled Physician's office visits, urgent care visits, and emergency department (ED) visits. | Posted | Mean | Standard Deviation | Number of visits | 6 months pre-treatment and 6 months post-treatment with the Volara System |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Number of days | 6 months pre-treatment and 6 months post-treatment with the Volara System |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | minutes/day | Total number of days the subject had the device (approximately up to 6 months of OLE therapy) |
|
|
|
| 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. | All responses obtained are presented. Some patients did not provide feedback at certain follow-up visits. | Posted | Mean | Standard Deviation | Score on SRI scale | Baseline, and after 1 month, 3 months, and 6 months of therapy using the Volara System |
|
|
|
| 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | After 1 month of using the Volara System |
|
|
|
| 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. | Posted | Count of Participants | Participants | After 3 months of using the Volara System |
|
|
|
| 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. | Posted | Count of Participants | Participants | After 6 months of using the Volara System |
|
|
|
| 2 |
| 41 |
| 0 |
| 33 |
| 2 |
| 33 |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Non-systematic Assessment |
|
The sponsor reserves the right of prior review and approval of data from this study relative to the potential release of proprietary information to any publication or for any presentation.
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| Title | Measurements |
|---|---|
|
| Q1R4. It is fairly easy to use the current airway clearance therapy |
|
| Q1R5. It is very easy to use the current airway clearance therapy |
|
| Q1R0. No answer on ease/difficulty of using the current airway clearance therapy |
|
| Q2R1. It is so difficult to tolerate the current airway clearance therapy that I don't want to do it |
|
| Q2R2. It is very difficult to tolerate the current airway clearance therapy |
|
| Q2R3. It is moderately difficult to tolerate the current airway clearance therapy |
|
| Q2R4. It is fairly easy to tolerate the current airway clearance therapy |
|
| Q2R5. It is very easy to tolerate the current airway clearance therapy |
|
| Q2R0. No answer on ease/difficulty of tolerating the current airway clearance therapy |
|
| Q3R1. I never miss therapy with the current airway clearance therapy |
|
| Q3R2. I miss therapy once a week |
|
| Q3R3. I miss therapy twice a week |
|
| Q3R4. I miss therapy three times a week |
|
| Q3R5. I miss therapy four or more times a week |
|
| Q3R0. No response on frequency of missing therapy per week |
|
| Q4R1. The current airway clearance is not effective as I never bring up sputum with therapy |
|
| Q4R2. The current airway clearance therapy is effective sometimes |
|
| Q4R3. The current airway clearance therapy is mostly effective |
|
| Q4R4. The current airway clearance therapy is almost always effective |
|
| Q4R5. I always bring up sputum with therapy |
|
| Q4R0. No answer on effectiveness of current airway clearance therapy on bringing up sputum |
|
| Q5R1. I always feel short of breath |
|
| Q5R2. I frequently have shortness of breath episodes |
|
| Q5R3. I have some shortness of breath episodes |
|
| Q5R4. I have a few shortness of breath episodes |
|
| Q5R5. I never have shortness of breath |
|
| Q5R0. No answer on effect of current airway clearance therapy on breathing |
|
| Q6R1. I do not feel the current airway clearance therapy helps my lungs stay healthy |
|
| Q6R2. I am unsure if this therapy helps my lungs stay healthy |
|
| Q6R3. This therapy seems somewhat helpful helpful for my lungs |
|
| Q6R4. I feel this therapy helps my lungs stay healthy |
|
| Q6R5. I definitely feel this therapy helps my lungs stay healthy |
|
| Q6R0. No answer on whether patients feel the current therapy helps their lungs feel healthy |
|
| Q7R1. My ability to perform daily tasks has definitely not improved |
|
| Q7R2. My ability to perform daily tasks has not improved |
|
| Q7R3. I am unsure if my ability to perform daily tasks has improved |
|
| Q7R4. I have had some improvement in ability to perform daily tasks |
|
| Q7R5. I have had significant improvement in ability to perform daily tasks |
|
| Q7R0. No answer on effect of current therapy on ability to perform daily tasks |
|
|
| Q1R4. It is fairly easy to use the Volara System |
|
| Q1R5. It is very easy to use the Volara System |
|
| Q1R0. No answer on ease/difficulty 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 |
|
| Q2R2. It is very difficult to tolerate therapy with the Volara System |
|
| Q2R3. It is moderately difficult to tolerate therapy with the Volara System |
|
| Q2R4. It is fairly easy to tolerate therapy with the Volara System |
|
| Q2R5. It is very easy to tolerate therapy with the Volara System |
|
| Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System |
|
| Q3R1. I never miss therapy |
|
| Q3R2. I miss therapy once a week |
|
| Q3R3. I miss therapy twice a week |
|
| Q3R4. I miss therapy three times a week |
|
| Q3R5. I miss therapy four or more times a week |
|
| Q3R0. No response on frequency of missing therapy per week |
|
| Q4R1. The therapy is not effective as I never bring up sputum with therapy |
|
| Q4R2. The therapy is effective sometimes |
|
| Q4R3. The therapy is mostly effective |
|
| Q4R4. The therapy is almost always effective |
|
| Q4R5. I always bring up sputum with therapy |
|
| Q4R0. No answer on effectiveness of therapy in bringing up sputum |
|
| Q5R1. I always feel short of breath |
|
| Q5R2. I frequently have shortness of breath episodes |
|
| Q5R3. I have some shortness of breath episodes |
|
| Q5R4. I have a few shortness of breath episodes |
|
| Q5R5. I never have shortness of breath |
|
| Q5R0. No answer on effect of therapy on breathing |
|
| Q6R1. I do not feel the therapy helps my lungs stay healthy |
|
| Q6R2. I am unsure if this therapy helps my lungs stay healthy |
|
| Q6R3. This therapy seems somewhat helpful helpful for my lungs |
|
| Q6R4. I feel this therapy helps my lungs stay healthy |
|
| Q6R5. I definitely feel this therapy helps my lungs stay healthy |
|
| Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy |
|
| Q7R1. My ability to perform daily tasks has definitely not improved |
|
| Q7R2. My ability to perform daily tasks has not improved |
|
| Q7R3. I am unsure if my ability to perform daily tasks has improved |
|
| Q7R4. I have had some improvement in ability to perform daily tasks |
|
| Q7R5. I have had significant improvement in ability to perform daily tasks |
|
| Q7R0. No answer on effect of current therapy on ability to perform daily tasks |
|
| Q8R1. I do not want to continue. I strongly prefer to use my previous therapy |
|
| Q8R2. I prefer to use my previous therapy |
|
| Q8R3. I do not have a preference on which therapy I use |
|
| Q8R4. I prefer to continue to do therapy with the Volara System |
|
| Q8R5. I strongly prefer to continue to do therapy with the Volara System |
|
| Q8R0. No answer given on therapy preference |
|
|
| Q1R4. It is fairly easy to use the Volara System |
|
| Q1R5. It is very easy to use the Volara System |
|
| Q1R0. No answer on ease/difficulty 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 |
|
| Q2R2. It is very difficult to tolerate therapy with the Volara System |
|
| Q2R3. It is moderately difficult to tolerate therapy with the Volara System |
|
| Q2R4. It is fairly easy to tolerate therapy with the Volara System |
|
| Q2R5. It is very easy to tolerate therapy with the Volara System |
|
| Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System |
|
| Q3R1. I never miss therapy |
|
| Q3R2. I miss therapy once a week |
|
| Q3R3. I miss therapy twice a week |
|
| Q3R4. I miss therapy three times a week |
|
| Q3R5. I miss therapy four or more times a week |
|
| Q3R0. No response on frequency of missing therapy per week |
|
| Q4R1. The therapy is not effective as I never bring up sputum with therapy |
|
| Q4R2. The therapy is effective sometimes |
|
| Q4R3. The therapy is mostly effective |
|
| Q4R4. The therapy is almost always effective |
|
| Q4R5. I always bring up sputum with therapy |
|
| Q4R0. No answer on effectiveness of therapy in bringing up sputum |
|
| Q5R1. I always feel short of breath |
|
| Q5R2. I frequently have shortness of breath episodes |
|
| Q5R3. I have some shortness of breath episodes |
|
| Q5R4. I have a few shortness of breath episodes |
|
| Q5R5. I never have shortness of breath |
|
| Q5R0. No answer on effect of therapy on breathing |
|
| Q6R1. I do not feel the therapy helps my lungs stay healthy |
|
| Q6R2. I am unsure if this therapy helps my lungs stay healthy |
|
| Q6R3. This therapy seems somewhat helpful helpful for my lungs |
|
| Q6R4. I feel this therapy helps my lungs stay healthy |
|
| Q6R5. I definitely feel this therapy helps my lungs stay healthy |
|
| Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy |
|
| Q7R1. My ability to perform daily tasks has definitely not improved |
|
| Q7R2. My ability to perform daily tasks has not improved |
|
| Q7R3. I am unsure if my ability to perform daily tasks has improved |
|
| Q7R4. I have had some improvement in ability to perform daily tasks |
|
| Q7R5. I have had significant improvement in ability to perform daily tasks |
|
| Q7R0. No answer on effect of current therapy on ability to perform daily tasks |
|
| Q8R1. I do not want to continue. I strongly prefer to use my previous therapy |
|
| Q8R2. I prefer to use my previous therapy |
|
| Q8R3. I do not have a preference on which therapy I use |
|
| Q8R4. I prefer to continue to do therapy with the Volara System |
|
| Q8R5. I strongly prefer to continue to do therapy with the Volara System |
|
| Q8R0. No answer given on therapy preference |
|
|
| Q1R4. It is fairly easy to use the Volara System |
|
| Q1R5. It is very easy to use the Volara System |
|
| Q1R0. No answer on ease/difficulty 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 |
|
| Q2R2. It is very difficult to tolerate therapy with the Volara System |
|
| Q2R3. It is moderately difficult to tolerate therapy with the Volara System |
|
| Q2R4. It is fairly easy to tolerate therapy with the Volara System |
|
| Q2R5. It is very easy to tolerate therapy with the Volara System |
|
| Q2R0. No answer on ease/difficulty of tolerating therapy with the Volara System |
|
| Q3R1. I never miss therapy |
|
| Q3R2. I miss therapy once a week |
|
| Q3R3. I miss therapy twice a week |
|
| Q3R4. I miss therapy three times a week |
|
| Q3R5. I miss therapy four or more times a week |
|
| Q3R0. No response on frequency of missing therapy per week |
|
| Q4R1. The therapy is not effective as I never bring up sputum with therapy |
|
| Q4R2. The therapy is effective sometimes |
|
| Q4R3. The therapy is mostly effective |
|
| Q4R4. The therapy is almost always effective |
|
| Q4R5. I always bring up sputum with therapy |
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| Q4R0. No answer on effectiveness of therapy in bringing up sputum |
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| Q5R1. I always feel short of breath |
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| Q5R2. I frequently have shortness of breath episodes |
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| Q5R3. I have some shortness of breath episodes |
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| Q5R4. I have a few shortness of breath episodes |
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| Q5R5. I never have shortness of breath |
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| Q5R0. No answer on effect of therapy on breathing |
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| Q6R1. I do not feel the therapy helps my lungs stay healthy |
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| Q6R2. I am unsure if this therapy helps my lungs stay healthy |
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| Q6R3. This therapy seems somewhat helpful helpful for my lungs |
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| Q6R4. I feel this therapy helps my lungs stay healthy |
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| Q6R5. I definitely feel this therapy helps my lungs stay healthy |
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| Q6R0. No answer on whether patients feel the therapy helps their lungs feel healthy |
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| Q7R1. My ability to perform daily tasks has definitely not improved |
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| Q7R2. My ability to perform daily tasks has not improved |
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| Q7R3. I am unsure if my ability to perform daily tasks has improved |
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| Q7R4. I have had some improvement in ability to perform daily tasks |
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| Q7R5. I have had significant improvement in ability to perform daily tasks |
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| Q7R0. No answer on effect of current therapy on ability to perform daily tasks |
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| Q8R1. I do not want to continue. I strongly prefer to use my previous therapy |
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| Q8R2. I prefer to use my previous therapy |
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| Q8R3. I do not have a preference on which therapy I use |
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| Q8R4. I prefer to continue to do therapy with the Volara System |
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| Q8R5. I strongly prefer to continue to do therapy with the Volara System |
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| Q8R0. No answer given on therapy preference |
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