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COVID-19
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| Name | Class |
|---|---|
| Inogen Inc. | INDUSTRY |
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To evaluate changes in activity based on the use of portable oxygen concentrators combined with standard of care (SOC) long- term oxygen therapy versus SOC long-term oxygen therapy alone at 12 weeks in patients with COPD who require continuous (24/7) long-term oxygen therapy. The study will also assess oxygen usage, quality of life, hospitalizations and death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Of Care (SOC) | No Intervention | Standard of care long-term oxygen therapy | |
| SOC + POC (Portable Oxygen Concentrator) | Experimental | Standard of care long-term oxygen therapy + POC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable Oxygen Concentrator (POC) | Device | COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC) |
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| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Level | Change in physical activity level (PAL) as measured through actigraphy. Outcome measure is the change between the value at Week 12 and Day 1 (Baseline). Min = 0; Max = infinite. A large positive change would indicate the participant increased their activity level at 12 weeks in comparison to Day 1. Physical activity level (PAL) is the ratio of total energy expenditure (TEE) to sleep energy expenditure (SEE). TEE is the total number of wear-filtered kilocalories expended in a day and SEE is the total number of sleep- and wear-filtered kilocalories expended in a day. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| St. George Respiratory Questionnaire (SGRQ) | Change in total SGRQ score between Week 12 and Baseline (Day1 ). Measures quality of life in patients with airway obstruction. Scores range from 0 to 100, with higher scores indicating more limitations. | 12 weeks |
| Oxygen Usage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MaryKay Sobcinski | RCRI | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| University of Illinois, Chicago |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Of Care (SOC) | Standard of care long-term oxygen therapy |
| FG001 | SOC + POC (Portable Oxygen Concentrator) | Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jan 29, 2018 | May 21, 2021 |
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Change in Total Hours of Use |
| 12 weeks |
| Hospital Anxiety and Depression Scale (HADS): Anxiety | Outcome measure is the change from Baseline (Day 1) and Week 12. HADS questionnaire measures anxiety and depression. A patient can score between 0-21, scores of less than 7 indicate non-cases. | 12 weeks |
| Chicago |
| Illinois |
| 60608 |
| United States |
| St. Vincent Airways | Indianapolis | Indiana | 46260 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Kentucky Research Group | Louisville | Kentucky | 40218 | United States |
| ClinSite LLC | Ann Arbor | Michigan | 48106 | United States |
| Minnesota Lung Center | Edina | Minnesota | 55435 | United States |
| Minnesota Lung Center | Minneapolis | Minnesota | 55407 | United States |
| Minnesota Lung Center | Woodbury | Minnesota | 55125 | United States |
| Sierra Clinical Research | Las Vegas | Nevada | 89106 | United States |
| UPMC Emphysema/COPD Research Center | Pittsburgh | Pennsylvania | 15213 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were collected from all participants who signed the ICF; some of these participants did not complete the First study visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Of Care (SOC) | Standard of care long-term oxygen therapy |
| BG001 | SOC + POC (Portable Oxygen Concentrator) | Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| 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 | Physical Activity Level | Change in physical activity level (PAL) as measured through actigraphy. Outcome measure is the change between the value at Week 12 and Day 1 (Baseline). Min = 0; Max = infinite. A large positive change would indicate the participant increased their activity level at 12 weeks in comparison to Day 1. Physical activity level (PAL) is the ratio of total energy expenditure (TEE) to sleep energy expenditure (SEE). TEE is the total number of wear-filtered kilocalories expended in a day and SEE is the total number of sleep- and wear-filtered kilocalories expended in a day. | Includes only patients that had evaluable PAL data (via ActiGraph watch) at both baseline and 12 weeks. | Posted | Mean | Standard Deviation | Ratio | 12 weeks |
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| Secondary | St. George Respiratory Questionnaire (SGRQ) | Change in total SGRQ score between Week 12 and Baseline (Day1 ). Measures quality of life in patients with airway obstruction. Scores range from 0 to 100, with higher scores indicating more limitations. | Includes only patients with evaluable and complete SGRQ data at both Baseline and Week 12. | Posted | Mean | Standard Deviation | score on a scale SGRQ | 12 weeks |
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| Secondary | Oxygen Usage | Change in Total Hours of Use | Posted | Mean | Standard Deviation | hours | 12 weeks |
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| Secondary | Hospital Anxiety and Depression Scale (HADS): Anxiety | Outcome measure is the change from Baseline (Day 1) and Week 12. HADS questionnaire measures anxiety and depression. A patient can score between 0-21, scores of less than 7 indicate non-cases. | Only includes patients with complete HADS data at both Baseline and Week 12. | Posted | Mean | Standard Deviation | score on a scale HADS | 12 weeks |
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Duration of the study = 12 weeks.
All AEs were collected during the course of the study. Events were categorized as hospitalizations or exacerbations of COPD, respiratory-related event, or Other. Trial sites and Investigators were allowed to capture non-categorized events as "Other".
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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 | Standard Of Care (SOC) | Standard of care long-term oxygen therapy | 1 | 54 | 6 | 54 | 21 | 54 |
| EG001 | SOC + POC (Portable Oxygen Concentrator) | Standard of care long-term oxygen therapy + POC Portable Oxygen Concentrator (POC): COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC) | 0 | 54 | 1 | 54 | 16 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Other respiratory-related condition | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Other respiratory-related condition | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maureen Crocker, Sr. Manager Market Access | ResMed | +65 9815 2195 | maureen.crocker@resmed.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2020 | May 21, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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