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The purpose of this study is to determine whether the new inhaler, Bevespi improves lung function. Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, that can provide useful images of the functioning of the lung will be used as a new measure to determine change in function. The investigator anticipate these images will provide more specific information about lung disease than standard lung function tests in response to treatment.
The study will characterize ventilation and gas transfer distributions in GOLD II and III COPD patients and assess the potential for these physiological parameters as a novel phenotyping method using Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas.
The study will additionally quantify regional ventilation and gas transfer response to glycopyrrolate/formoterol in GOLD II and III COPD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | glycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study XeMRI. A follow up xeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperpolarized 129Xe gas MRI | Drug | There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilation Distribution as Measured by Ventilation Defect+Low Percent | The ventilation distribution as measured by ventilation defect+low percent is to measure the area of the lung that has no air. | Week 2 |
| Barrier Uptake. | Diffusion of Xe gas across the lung membrane into the blood. This measures how well oxygen goes through the lung into the blood. | 2 weeks |
| Red Blood Cell (RBC) Uptake | Amount of Xe gas that enters the blood stream after it diffuses across the lung membrane | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Function Test - Forced Vital Capacity (FVC) | Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry. | 2 weeks |
| Pulmonary Function Test - Forced Expiratory Volume-one Second (FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
Upper respiratory tract infection within 6 weeks
Chronic systemic corticosteroid use > 10 mg/day of prednisone
Chronic oxygen use (intermittent or continuous)
Previous lung resection surgery or decortication
Previous history of pneumothorax
Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies
History of exposure to occupational or environmental hazards that are known to cause lung diseases
For women of child bearing potential, positive pregnancy test
Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study
Patients who are not willing to withhold COPD inhalers for the run-in period.
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| Name | Affiliation | Role |
|---|---|---|
| Yuh Chin Huang, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Asthma, Allergy, and Airway Center | Durham | North Carolina | 27705 | United States |
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All subjects who were on regular inhalation therapies for COPD underwent a wash-out period of 7-14 days, during which time they stopped all inhaled corticosteroids, long-acting beta agonist (LABA), and long-acting muscarinic receptor antagonist (LAMA). The subjects were allowed to use inhaled albuterol as needed.
Between April 2018 and October 2019, 52 outpatient pulmonary clinic patients were approached about potential participation in the study. Twenty-six participants signed a written informed consent prior to enrollment and the HIPAA-compliant study protocol was approved by the Institutional Review Board of Duke University Medical Center (Pro00086693). Six participants were either withdrawn by the PI or voluntarily withdrew prior to starting the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Twenty patients with a pulmonologist's diagnosis of either GOLD II or III COPD and no significant comorbidities were recruited. One patient was excluded from data analysis due to poor image signal-to-noise ratio, and two patients did not have both pre- and post-treatment ventilation images; thus, a total of 17 patients (8M; 9F) were included in the data analysis. The mean age was 64.3 ± 4.9. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects who were on regular inhalation therapies for COPD underwent a wash-out period of 7-14 days, during which time they stopped all inhaled corticosteroids, long-acting beta agonist (LABA), and long-acting muscarinic receptor antagonist (LAMA). The subjects were allowed to use inhaled albuterol as needed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Twenty subjects completed the study. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit; thus, a total of 17 subjects (8M 9F) were included in the data analysis. Subjects were treated with Bevespi 2 puffs twice a day for 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age measured in years | 3 subjects were excluded due to incomplete data or poor data quality |
| 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 | Ventilation Distribution as Measured by Ventilation Defect+Low Percent | The ventilation distribution as measured by ventilation defect+low percent is to measure the area of the lung that has no air. | 17 participants were included in the data analysis. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Mean | Standard Deviation | percentage of total ventilation | Week 2 |
|
1 month
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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 | Treatment | glycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study xeMRI. A follow up xeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design. hyperpolarized 129Xe gas MRI: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality. Bevespi Aerosphere: There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. |
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20 subjects completed the study. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit; thus, a total of 17 subjects (8M 9F) were included in the data analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yuh-Chin T. Huang, MD, MHS | Duke University Medical Center | 9196843069 | huang002@mc.duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2017 | Nov 9, 2020 | Prot_SAP_000.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 |
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| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
|
| Bevespi Aerosphere | Drug | There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. |
|
|
FEV1 is a lung airflow measure to assess the amount of air that can be blown out in one second. |
| 2 weeks |
| Pulmonary Function Test - Total Lung Capacity (TLC) | Total Lung Capacity (TLC) is the volume in the lungs at a maximal inhalation. | 2 weeks |
| Pulmonary Function Test - Residual Volume (RV) | Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation. | 2 weeks |
| Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | DLCO measures the ability of oxygen to travel from the air sacs of the lungs to the blood stream. | 2 weeks |
| 6-minute Walk Test (6MWT) | The 6-minute walk test (6MWT) measures the distance walked at a natural pace for 6 minutes. | 2 weeks |
| St. George's Respiratory Questionnaire (SGRQ) Score | The SGRQ is used to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations. | 2 weeks |
| Rating of Perceived Dyspnea (RPD) Scale | A patient reported outcome to measure perceived exertion during physical activity. The RPD scale goes from 0 to 10, where 0 = no shortness of breath at all and 10 = maximal shortness of breath (needing to stop the exercise or activity). | 2 weeks |
| COPD Assessment Test (CAT) Score | Functional measurement for COPD patients. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. | 2 weeks |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 3 subjects were excluded due to incomplete data or poor data quality | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Primary | Barrier Uptake. | Diffusion of Xe gas across the lung membrane into the blood. This measures how well oxygen goes through the lung into the blood. | 17 patients with GOLD 2 or 3 COPD 17 participants were included in the data analysis. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Primary | Red Blood Cell (RBC) Uptake | Amount of Xe gas that enters the blood stream after it diffuses across the lung membrane | GOLD 2 and 3 COPD 17 participants were included in the data analysis. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Pulmonary Function Test - Forced Vital Capacity (FVC) | Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry. | One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. 17 participants were included in the data analysis. One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Mean | Standard Deviation | ml | 2 weeks |
|
|
|
| Secondary | Pulmonary Function Test - Forced Expiratory Volume-one Second (FEV1) | FEV1 is a lung airflow measure to assess the amount of air that can be blown out in one second. | One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Mean | Standard Deviation | ml | 2 weeks |
|
|
|
| Secondary | Pulmonary Function Test - Total Lung Capacity (TLC) | Total Lung Capacity (TLC) is the volume in the lungs at a maximal inhalation. | One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Mean | Standard Deviation | ml | 2 weeks |
|
|
|
| Secondary | Pulmonary Function Test - Residual Volume (RV) | Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation. | One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Mean | Standard Deviation | ml | 2 weeks |
|
|
|
| Secondary | Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | DLCO measures the ability of oxygen to travel from the air sacs of the lungs to the blood stream. | One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Mean | Standard Deviation | mL/min/mmHg | 2 weeks |
|
|
|
| Secondary | 6-minute Walk Test (6MWT) | The 6-minute walk test (6MWT) measures the distance walked at a natural pace for 6 minutes. | One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Mean | Standard Deviation | meters | 2 weeks |
|
|
|
| Secondary | St. George's Respiratory Questionnaire (SGRQ) Score | The SGRQ is used to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations. | One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Secondary | Rating of Perceived Dyspnea (RPD) Scale | A patient reported outcome to measure perceived exertion during physical activity. The RPD scale goes from 0 to 10, where 0 = no shortness of breath at all and 10 = maximal shortness of breath (needing to stop the exercise or activity). | One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Secondary | COPD Assessment Test (CAT) Score | Functional measurement for COPD patients. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. | One subject was excluded from data analysis due to poor image signal-to-noise ratio (SNR), and two elected not to return for a post-treatment visit. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |