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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The overall goal of this study is to understand biological responses related to dupilumab treatment among severe asthma patients.
Not all asthma is the same, and characteristics of asthma vary from person to person. The study will investigate whether the study drug can help to improve the health of participants lungs, boost immune response, as well as improve quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Participants will receive 8 doses of Dupilumab. The initial loading dose (visit 1) of 600 milligrams (two 300 milligram injections) will be given subcutaneously (SQ). Then the participants will receive 300 milligrams SQ every other week (q 2 weeks) either at a study visit or self-administered at home between visits. Additionally, participants will complete questionnaires, have specimens collected, as well as perform breathing procedures at various timepoints. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Alpha-diversity of Respiratory Microbiota | α-diversity was calculated using the Shannon Diversity Index at the species level from induced sputum samples obtained at Baseline and after 1 month on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | Baseline (before dupilumab), 1 month |
| Changes in Alpha-diversity of Respiratory Microbiota | α-diversity was calculated using the Shannon Diversity Index at the species level from induced sputum samples obtained at baseline and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | Baseline (before dupilumab), 4 month |
| Changes in Alpha-diversity of Respiratory Microbiota | α-diversity was calculated using the Shannon Diversity Index at the species level from induced sputum samples obtained after 1 month and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | 1 month, 4 months |
| Change in Beta-diversity of Respiratory Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from induced sputum samples obtained at baseline and after 1 month on dupilumab. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance, which is unitless, indicates a greater difference in diversity between the time points. |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume ( FEV1) / Forced Vital Capacity (FVC) Ratio | Ratio of the volume of air exhaled in 1 sec (FEV1) divided by the total volume exhaled (FVC). FEV1/FVC < 0.70 (or less than lower limit of age-predicted normal) is clinically diagnostic of obstructive lung disease. | Baseline, 1 month, 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Huang, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dupilumab | Dupilumab: Participants will receive 8 doses of Dupilumab. The initial loading dose (visit 1) of 600 milligrams (two 300 milligram injections) will be given subcutaneously (SQ). Then the participants will receive 300 milligrams SQ every other week (q 2 weeks) either at a study visit or self-administered at home between visits. Additionally, participants will complete questionnaires, have specimens collected, as well as perform breathing procedures at various timepoints. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dupilumab | Dupilumab: Participants will receive 8 doses of Dupilumab. The initial loading dose (visit 1) of 600 milligrams (two 300 milligram injections) will be given subcutaneously (SQ). Then the participants will receive 300 milligrams SQ every other week (q 2 weeks) either at a study visit or self-administered at home between visits. Additionally, participants will complete questionnaires, have specimens collected, as well as perform breathing procedures at various timepoints. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Changes in Alpha-diversity of Respiratory Microbiota | α-diversity was calculated using the Shannon Diversity Index at the species level from induced sputum samples obtained at Baseline and after 1 month on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | Shannon's index | Baseline (before dupilumab), 1 month |
|
4 months
Non-serious adverse event information was not collected.
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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 | Dupilumab | Dupilumab: Participants will receive 8 doses of Dupilumab. The initial loading dose (visit 1) of 600 milligrams (two 300 milligram injections) will be given subcutaneously (SQ). Then the participants will receive 300 milligrams SQ every other week (q 2 weeks) either at a study visit or self-administered at home between visits. Additionally, participants will complete questionnaires, have specimens collected, as well as perform breathing procedures at various timepoints. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia-attributed acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yvonne J Huang MD | University of Michigan | 734-936-5047 | yvjhuang@med.umich.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 | Sep 8, 2021 | Jun 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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|
|
| Baseline (before dupilumab), 1 month |
| Change in Beta-diversity of Respiratory Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from induced sputum samples obtained at baseline and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance indicates a greater difference in diversity between time points. | Baseline (before dupilumab), 4 month |
| Change in Beta-diversity of Respiratory Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from induced sputum samples obtained after 1 month and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance indicates a greater difference in diversity between time points. | 1 month, 4 months |
| Change in Relative Abundances of Microbiota Members | Relative abundance was calculated by finding the proportion of a classified species out of all bacterial classifications in an induced sputum sample. Relative abundance was calculated at baseline and after 1 month on dupilumab. The change in relative abundance of each species across all available samples was calculated by taking the difference between time points. | Baseline (before dupilumab), 1 month |
| Change in Relative Abundances of Microbiota Members | Relative abundance was calculated by finding the proportion of a classified species out of all bacterial classifications in an induced sputum sample. Relative abundance was calculated at baseline and after 4 months on dupilumab. The change in relative abundance of each species across all available samples was calculated by taking the difference between time points. | Baseline (before dupilumab), 4 month |
| Change in Relative Abundances of Microbiota Members | Relative abundance was calculated by finding the proportion of a classified species out of all bacterial classifications in an induced sputum sample. Relative abundance was calculated after 1 month and after 4 months on dupilumab. The change in relative abundance of each species across all available samples was calculated by taking the difference between time points. | 1 month, 4 months |
| Change in Respiratory Bacterial Burden | Bacterial burden was estimated by scaling species relative abundances to a known cell count of Imtechella halotolerans (Zymo) that was spiked into an induced sputum sample before extraction for sequencing. Bacterial burden was calculated at baseline and after 1 month on dupilumab. The change in bacterial burden was calculated by aggregating all burden values per participant and taking the difference between time points. | Baseline (before dupilumab), 1 month |
| Change in Respiratory Bacterial Burden | Bacterial burden was estimated by scaling all species relative abundances to a known cell count of Imtechella halotolerans that was spiked into sputum samples before extraction for sequencing. Bacterial burden was calculated at baseline and after 4 months on dupilumab. The change in bacterial burden was calculated by aggregating all burden values per participant and taking the difference between time points. | Baseline (before dupilumab), 4 month |
| Change in Respiratory Bacterial Burden | Bacterial Burden was estimated by scaling the species relative abundance to a known cell count of I. Halotolerans that was spiked into an induced sputum sample before extraction for sequencing. Bacterial burden was calculated at after 1 month and after 4 months on dupilumab. The change in bacterial burden was calculated by aggregating all burden values per participant and taking the difference between time points. | 1 month, 4 months |
| Changes in Alpha-diversity of Stool Microbiota | α-diversity was calculated using the Shannon diversity index at the species level from stool samples obtained at baseline and after 1 month on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | Baseline (before dupilumab), 1 month |
| Changes in Alpha-diversity of Stool Microbiota | α-diversity was calculated using the Shannon diversity Index at the species level from stool samples obtained at baseline and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | Baseline (before dupilumab), 4 month |
| Changes in Alpha-diversity of Stool Microbiota | α-diversity was calculated using the Shannon Diversity Index at the species level from stool samples. Shannon's Diversity Index values were obtained after 1 month and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | 1 month, 4 months |
| Change in Beta-diversity of Stool Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from stool samples. Samples were obtained baseline and after 1 month on dupilumab and the Bray-Curtis Distance calculated. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance indicates a greater difference in diversity between time points.. | Baseline (before dupilumab), 1 month |
| Change in Beta-diversity of Stool Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from stool samples obtained at baseline and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance indicates a greater difference in diversity between time points. | Baseline (before dupilumab), 4 month |
| Change in Beta-diversity of Stool Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from stool samples obtained after 1 month and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance indicates a greater difference in diversity between time points. | 1 month, 4 months |
| Forced Expiratory Volume (FEV1) |
FEV1 measure reported as a percentage of predicted FEV1. |
| Baseline, 1 month, 4 months |
| Change in Fractional Exhaled Nitric Oxide (FeNO) | Fractional exhaled nitric oxide is a clinical biomarker for type 2 airway inflammation. FeNO >25 is considered indicative of type 2 airway inflammation. | Baseline, 1 month, 4 months |
| Asthma Control Test (ACT) | The Asthma Control Test is a clinically validated questionnaire that assesses level of asthma control based on a 4-week recall of symptoms and daily functioning captured in 5 items. Each item is scored on a 5-point scale, and the total score is the sum of the values for all 5 items (range 5-25). A score of 5 represents worst-controlled asthma and 25 represents best-controlled asthma. An ACT score >19 indicates well-controlled asthma; the minimal clinically important difference in score is 3. | Baseline, 1 month, 4 months |
| Mini Asthma Quality of Life Questionnaire Score (mAQLQ) | The mini-Asthma Quality of Life Questionnaire (mAQLQ) consists of 15 questions covering 4 domains: symptoms (5 questions), activity limitations (4 questions), emotional function (3 questions), and environmental stimuli (3 questions). The recall time for the mAQLQ is 2 weeks and each item is scored on a 7-point scale. Total scores per participant are the average of the 15 items and range from 1-7, with higher scores indicative of better quality of life. The minimum clinically important difference is 0.5. | Baseline, 1 month, 4 months |
| Sino-nasal Outcome Test (SNOT-22) | This is a 22 item questionnaire. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The score ranges between 0 and 110. A higher score means worse outcome. | Baseline, 1 month, 4 months |
| Change in Prescribed Maintenance Corticosteroid Use (Inhaled or Oral), Between Baseline and 4 Months. | Count of participants whose maintenance corticosteroid prescription changed between baseline and 4 months. | Baseline, 4 months |
| Number of Asthma Exacerbations Requiring at Least 3 Days of Oral Corticosteroids | Number of asthma exacerbations requiring at least 3 days of oral corticosteroids across the entire study population over the course of the study. | up to 4 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| FEV1:FVC | Median | Standard Deviation | ratio |
|
| Body-mass index | Median | Standard Deviation | (kg/m^2) |
|
| Fractional exhaled nitric oxide (FeNO) | Median | Standard Deviation | parts per billion |
|
| Asthma Control Test (ACT) score | The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. | Median | Standard Deviation | score on a scale |
|
| Sino-nasal outcome test (SNOT-22) score | The possible range of Total SNOT scores is between 0 to 110 for the SNOT-22. Higher scores indicate greater rhinosinusitis-related health burden. | Median | Standard Deviation | score on a scale |
|
| mini-Asthma Quality of Life Questionnaire (mAQLQ) score | This is a patient self-administered questionnaire with 15 questions covering 4 domains: Symptoms (5 questions), Activity Limitations (4 questions), Emotional Function (3 questions), and Environmental Stimuli (3 questions). Scores range from 0-6 (lower is worse). The mini AQLQ score is calculated as the average of domain items. The minimum clinically important difference is 0.5. Overall score (average of 15 questions): add up responses to all questions, and divide by 15. | Median | Standard Deviation | score on a scale |
|
| alpha-diversity of respiratory (sputum) microbiota: Shannon index | α-diversity was calculated using the Shannon Diversity Index at the species level from induced sputum samples. A higher Shannon Diversity Index value indicates higher diversity. | Mean | Standard Deviation | Shannon's index |
|
| Relative abundances of respiratory (sputum) microbiota members | Relative abundance was calculated by finding the proportion of a classified species out of all bacterial classifications in an induced sputum sample. | Mean | Standard Deviation | percentages |
|
| Respiratory bacterial burden (#bacterial cells, sputum) | Mean | Standard Deviation | bacterial cells |
|
| alpha-diversity of stool microbiota: Shannon index | α-diversity was calculated using the Shannon diversity Index at the species level from stool samples. A higher Shannon Diversity Index value indicates higher diversity. | Mean | Standard Deviation | score on a scale |
|
| Oral Corticosteroid Use | Number of participants using oral corticosteroids | Count of Participants | Participants |
|
| Blood eosinophils | Mean | Standard Deviation | cells/microliter |
|
|
|
| Primary | Changes in Alpha-diversity of Respiratory Microbiota | α-diversity was calculated using the Shannon Diversity Index at the species level from induced sputum samples obtained at baseline and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | Shannon's index | Baseline (before dupilumab), 4 month |
|
|
|
| Primary | Changes in Alpha-diversity of Respiratory Microbiota | α-diversity was calculated using the Shannon Diversity Index at the species level from induced sputum samples obtained after 1 month and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | Shannon's index | 1 month, 4 months |
|
|
|
| Primary | Change in Beta-diversity of Respiratory Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from induced sputum samples obtained at baseline and after 1 month on dupilumab. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance, which is unitless, indicates a greater difference in diversity between the time points. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | score on a scale | Baseline (before dupilumab), 1 month |
|
|
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| Primary | Change in Beta-diversity of Respiratory Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from induced sputum samples obtained at baseline and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance indicates a greater difference in diversity between time points. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | score on a scale | Baseline (before dupilumab), 4 month |
|
|
|
| Primary | Change in Beta-diversity of Respiratory Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from induced sputum samples obtained after 1 month and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance indicates a greater difference in diversity between time points. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | score on a scale | 1 month, 4 months |
|
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| Primary | Change in Relative Abundances of Microbiota Members | Relative abundance was calculated by finding the proportion of a classified species out of all bacterial classifications in an induced sputum sample. Relative abundance was calculated at baseline and after 1 month on dupilumab. The change in relative abundance of each species across all available samples was calculated by taking the difference between time points. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | percentage of bacterial classification | Baseline (before dupilumab), 1 month |
|
|
|
| Primary | Change in Relative Abundances of Microbiota Members | Relative abundance was calculated by finding the proportion of a classified species out of all bacterial classifications in an induced sputum sample. Relative abundance was calculated at baseline and after 4 months on dupilumab. The change in relative abundance of each species across all available samples was calculated by taking the difference between time points. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | percent of bacterial classification | Baseline (before dupilumab), 4 month |
|
|
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| Primary | Change in Relative Abundances of Microbiota Members | Relative abundance was calculated by finding the proportion of a classified species out of all bacterial classifications in an induced sputum sample. Relative abundance was calculated after 1 month and after 4 months on dupilumab. The change in relative abundance of each species across all available samples was calculated by taking the difference between time points. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | percent of bacterial classification | 1 month, 4 months |
|
|
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| Primary | Change in Respiratory Bacterial Burden | Bacterial burden was estimated by scaling species relative abundances to a known cell count of Imtechella halotolerans (Zymo) that was spiked into an induced sputum sample before extraction for sequencing. Bacterial burden was calculated at baseline and after 1 month on dupilumab. The change in bacterial burden was calculated by aggregating all burden values per participant and taking the difference between time points. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | cells | Baseline (before dupilumab), 1 month |
|
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| Primary | Change in Respiratory Bacterial Burden | Bacterial burden was estimated by scaling all species relative abundances to a known cell count of Imtechella halotolerans that was spiked into sputum samples before extraction for sequencing. Bacterial burden was calculated at baseline and after 4 months on dupilumab. The change in bacterial burden was calculated by aggregating all burden values per participant and taking the difference between time points. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | cells | Baseline (before dupilumab), 4 month |
|
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| Primary | Change in Respiratory Bacterial Burden | Bacterial Burden was estimated by scaling the species relative abundance to a known cell count of I. Halotolerans that was spiked into an induced sputum sample before extraction for sequencing. Bacterial burden was calculated at after 1 month and after 4 months on dupilumab. The change in bacterial burden was calculated by aggregating all burden values per participant and taking the difference between time points. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | cells | 1 month, 4 months |
|
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| Primary | Changes in Alpha-diversity of Stool Microbiota | α-diversity was calculated using the Shannon diversity index at the species level from stool samples obtained at baseline and after 1 month on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | Shannon's index | Baseline (before dupilumab), 1 month |
|
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| Primary | Changes in Alpha-diversity of Stool Microbiota | α-diversity was calculated using the Shannon diversity Index at the species level from stool samples obtained at baseline and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | Shannon's index | Baseline (before dupilumab), 4 month |
|
|
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| Primary | Changes in Alpha-diversity of Stool Microbiota | α-diversity was calculated using the Shannon Diversity Index at the species level from stool samples. Shannon's Diversity Index values were obtained after 1 month and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' calculated diversity and then finding the difference between time points. A higher Shannon Diversity Index value indicates higher diversity. A value of zero indicates the presence of only one kind of species of bacteria. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | Shannon's index | 1 month, 4 months |
|
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| Primary | Change in Beta-diversity of Stool Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from stool samples. Samples were obtained baseline and after 1 month on dupilumab and the Bray-Curtis Distance calculated. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance indicates a greater difference in diversity between time points.. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | score on a scale | Baseline (before dupilumab), 1 month |
|
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| Primary | Change in Beta-diversity of Stool Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from stool samples obtained at baseline and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance indicates a greater difference in diversity between time points. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | score on a scale | Baseline (before dupilumab), 4 month |
|
|
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| Primary | Change in Beta-diversity of Stool Microbiota | Beta-diversity was calculated using the Bray-Curtis Distance at the species level from stool samples obtained after 1 month and after 4 months on dupilumab. The change in diversity was calculated by aggregating all participants' distance between time points. Bray-Curtis dissimilarity ranges from 0 to 1. A higher Bray-Curtis Distance indicates a greater difference in diversity between time points. | While 15 participants completed treatment, not all participants were able to provide biosamples. All data collected from available samples is provided here. | Posted | Mean | Standard Deviation | score on a scale | 1 month, 4 months |
|
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| Secondary | Forced Expiratory Volume ( FEV1) / Forced Vital Capacity (FVC) Ratio | Ratio of the volume of air exhaled in 1 sec (FEV1) divided by the total volume exhaled (FVC). FEV1/FVC < 0.70 (or less than lower limit of age-predicted normal) is clinically diagnostic of obstructive lung disease. | Posted | Median | Full Range | ratio | Baseline, 1 month, 4 months |
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| Secondary | Forced Expiratory Volume (FEV1) | FEV1 measure reported as a percentage of predicted FEV1. | Posted | Median | Full Range | percent of predicted volume | Baseline, 1 month, 4 months |
|
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| Secondary | Change in Fractional Exhaled Nitric Oxide (FeNO) | Fractional exhaled nitric oxide is a clinical biomarker for type 2 airway inflammation. FeNO >25 is considered indicative of type 2 airway inflammation. | Posted | Median | Full Range | parts per billion | Baseline, 1 month, 4 months |
|
|
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| Secondary | Asthma Control Test (ACT) | The Asthma Control Test is a clinically validated questionnaire that assesses level of asthma control based on a 4-week recall of symptoms and daily functioning captured in 5 items. Each item is scored on a 5-point scale, and the total score is the sum of the values for all 5 items (range 5-25). A score of 5 represents worst-controlled asthma and 25 represents best-controlled asthma. An ACT score >19 indicates well-controlled asthma; the minimal clinically important difference in score is 3. | Posted | Median | Full Range | score on a scale | Baseline, 1 month, 4 months |
|
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| Secondary | Mini Asthma Quality of Life Questionnaire Score (mAQLQ) | The mini-Asthma Quality of Life Questionnaire (mAQLQ) consists of 15 questions covering 4 domains: symptoms (5 questions), activity limitations (4 questions), emotional function (3 questions), and environmental stimuli (3 questions). The recall time for the mAQLQ is 2 weeks and each item is scored on a 7-point scale. Total scores per participant are the average of the 15 items and range from 1-7, with higher scores indicative of better quality of life. The minimum clinically important difference is 0.5. | Posted | Median | Full Range | score on a scale | Baseline, 1 month, 4 months |
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|
|
| Secondary | Sino-nasal Outcome Test (SNOT-22) | This is a 22 item questionnaire. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The score ranges between 0 and 110. A higher score means worse outcome. | Posted | Median | Full Range | score on a scale | Baseline, 1 month, 4 months |
|
|
|
| Secondary | Change in Prescribed Maintenance Corticosteroid Use (Inhaled or Oral), Between Baseline and 4 Months. | Count of participants whose maintenance corticosteroid prescription changed between baseline and 4 months. | Posted | Count of Participants | Participants | Baseline, 4 months |
|
|
|
| Secondary | Number of Asthma Exacerbations Requiring at Least 3 Days of Oral Corticosteroids | Number of asthma exacerbations requiring at least 3 days of oral corticosteroids across the entire study population over the course of the study. | Posted | Number | count of exacerbations | up to 4 months |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| 0 |
| 0 |
| Respiratory difficulty requiring hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acute myeloid leukemia diagnosis | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Bifidobacterium longum |
|
| Tropheryma whipplei |
|
| Bifidobacterium dentium |
|
| Streptococcus gordonii |
|
| Parvimonas micra |
|
| Streptococcus anginosus |
|
| Rothia mucilaginosa |
|
| Title | Measurements |
|---|---|
|
| Bifidobacterium longum |
|
| Tropheryma whipplei |
|
| Bifidobacterium dentium |
|
| Streptococcus gordonii |
|
| Parvimonas micra |
|
| Streptococcus anginosus |
|
| Rothia mucilaginosa |
|
| Title | Measurements |
|---|---|
|
| Bifidobacterium longum |
|
| Tropheryma whipplei |
|
| Bifidobacterium dentium |
|
| Streptococcus gordonii |
|
| Parvimonas micra |
|
| Streptococcus anginosus |
|
| Rothia mucilaginosa |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|