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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL135235 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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To study the change from baseline in IL-1β (interleukin 1 beta) concentrations in the nasal airway during acute asthma exacerbation, specifically to measure the degree of change and identify the timing of peak IL-1β concentration. This information will allow the investigators to estimate effect size and guide decisions about the optimal timing of anakinra administration for the future study.
The study team will recruit 60 teens and young adults with persistent asthma who are at high risk for future exacerbation from the University of North Carolina at Chapel Hill (UNC) Children's Allergy and Asthma Center in Raleigh, NC. Participants will complete 13 study visits: an initial in-person visit (the study team will make every attempt to coordinate this visit with a scheduled clinic visit) and 12 monthly virtual follow up visits. Participants will be asked to use an at home spirometer once daily in the evening and will also complete an electronic asthma survey each night. Participants will also be provided with a sensor that tracks their rescue medication use throughout the study. Participants will undergo collection of nasal epithelial lining fluid (NELF) at the baseline visit. During the 12 months of study, participants will self-collect NELF samples if certain prespecified criteria for asthma exacerbation are met. Samples will be analyzed for IL-1β, interleukin receptor antagonist (IL-1RA) and other mediators associated with acute asthma exacerbation. Virtual follow up visits using a video platform will occur monthly for 12 months. Participants will self-report healthcare utilization and prescription for systemic corticosteroids. Spirometry and symptom survey data will be matched to subject-reported asthma exacerbations. The study design is adapted to minimize in-person visits, using web-based platforms for virtual visits and self-collection of samples to prioritize safety during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Nasal IL-1β (pg/mL) Concentrations During Asthma Exacerbation | Nasal epithelial lining fluid (NELF) is collected during a period of wellness (baseline) and daily during acute asthma exacerbation (defined by pre-specified criteria) for 5 days. This outcome is defined as the percent change from baseline in nasal IL-1β concentration during acute asthma exacerbation, calculated by comparing the peak concentration observed during the exacerbation to the baseline concentration (i.e., [(peak value of IL-1β during exacerbation - baseline value of IL-1β)/baseline value of IL-1β] x100). Results are summarized using the median and interquartile range. | Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Forced Expiratory Volume in the First Second (FEV1) in Liters During Asthma Exacerbation | FEV1 will be measured during a period of wellness (baseline) and daily during acute asthma exacerbation defined by pre-specified criteria for 5 days. This outcome is defined as the percent change from baseline in FEV1 during acute asthma exacerbation, calculated by comparing the maximum decline in FEV1 observed during the exacerbation to the baseline FEV1 [(max decline of FEV1 during exacerbation - baseline value of FEV1)/baseline value of FEV1] x100). |
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Inclusion Criteria:
Ages 12 to 21 years, inclusive, of both genders
Physician diagnosis of persistent asthma or symptoms consistent with persistent asthma based on expert guidelines for diagnosis and management of asthma (1).
Current use of a controller therapy such as an inhaled corticosteroid (ICS), ICS in combination with long-acting beta agonist (LABA), or leukotriene receptor antagonist (LTRA).
Asthma is "not well controlled" (participant must have ≥1 of the following):
In the past 4 weeks, has the patient had:
Daytime symptoms >2x/week?
Any night waking due to asthma?
SABA reliever needed >2x/week?
Any activity limitation due to asthma?
[0 = Well controlled; 1-2 = Partly controlled; 3-4 = Uncontrolled]
A history of at least one exacerbation requiring systemic corticosteroids (oral, IM or IV) in the past 24 months
Exclusion Criteria:
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The study team will recruit 60 teens and young adults with persistent asthma who are at high risk for future exacerbation from the UNC Children's Allergy and Asthma Center in Raleigh, NC.
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| Name | Affiliation | Role |
|---|---|---|
| Allison Burbank, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17983880 | Background | National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043. |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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9 to 36 months following publication
Approved IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
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A convenience sample of adolescent and young adult patients receiving asthma specialty care in pulmonology and/or allergy clinics was enrolled at a single institution.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | This was an observational study of adolescents and young adults with asthma |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This was an observational study of adolescents and young adults with asthma |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age in years at the time of consent |
| 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 | Percentage Change From Baseline in Nasal IL-1β (pg/mL) Concentrations During Asthma Exacerbation | Nasal epithelial lining fluid (NELF) is collected during a period of wellness (baseline) and daily during acute asthma exacerbation (defined by pre-specified criteria) for 5 days. This outcome is defined as the percent change from baseline in nasal IL-1β concentration during acute asthma exacerbation, calculated by comparing the peak concentration observed during the exacerbation to the baseline concentration (i.e., [(peak value of IL-1β during exacerbation - baseline value of IL-1β)/baseline value of IL-1β] x100). Results are summarized using the median and interquartile range. | The analysis population includes participants who experienced 1 or more exacerbations during the study period and for whom NELF samples were available for analysis. | Posted | Median | Inter-Quartile Range | percentage change from baseline | Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12) |
|
from enrollment until the final study visit at 12 months
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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 | All Participants | This was an observational study of adolescents and young adults with asthma |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant presented to the ED with severe muscle pain, found to have elevated serum CK levels, treated with IV fluids and NSAIDs. The event was graded as 'severe' and relationship to study intervention was deemed 'not related'. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | acute worsening of asthma symptoms significant enough to require treatment with systemic corticosteroids |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Hernandez, MD | University of North Carolina Chapel Hill | 9199625136 | michelle_hernandez@med.unc.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 27, 2021 | Apr 23, 2026 | 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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NELF
| Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12) |
| Percentage Change From Baseline in Nasal IL-1RA (pg/mL) Concentration During Asthma Exacerbation | Nasal epithelial lining fluid (NELF) is collected during a period of wellness (baseline) and daily during acute asthma exacerbation defined by pre-specified criteria for 5 days. This outcome is defined as the percent change from baseline in nasal IL-1RA concentration during acute asthma exacerbation, calculated by comparing the peak concentration observed during the exacerbation to the baseline concentration (i.e., [(peak value of IL-1RA during exacerbation - baseline value of IL-1RA)/baseline value of IL-1RA] x100). Results are summarized using the median and interquartile range. | Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12) |
| Correlation Over Time Between Percentage Change in Nasal IL-1β Concentration From Baseline and Percentage Change in FEV1 From Baseline During Asthma Exacerbation | Assess the relationship between the asthma exacerbation-induced percentage change from baseline in NELF IL-1β concentrations and the asthma exacerbation-induced percentage change from baseline in FEV1. Pearson's correlation coefficient will be calculated to evaluate the relationship between peak percentage increase in IL-1b levels from baseline and maximum percentage decline in FEV1 from baseline during exacerbation | Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12) |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Forced expiratory volume in 1 second (FEV1) | Baseline FEV1 percent of predicted | Median | Inter-Quartile Range | percent |
|
| Interleukin-1b (IL-1b) | Baseline IL-1b concentration in nasal epithelial lining fluid (NELF) | Median | Inter-Quartile Range | picograms per milliliter |
|
| Interleukin-1 receptor antagonist (IL-1RA) | Baseline IL-1RA concentration in nasal epithelial lining fluid (NELF) | Median | Inter-Quartile Range | picograms per milliliter |
|
| All Participants |
This was an observational study of adolescents and young adults with asthma |
|
|
| Secondary | Percentage Change From Baseline in Forced Expiratory Volume in the First Second (FEV1) in Liters During Asthma Exacerbation | FEV1 will be measured during a period of wellness (baseline) and daily during acute asthma exacerbation defined by pre-specified criteria for 5 days. This outcome is defined as the percent change from baseline in FEV1 during acute asthma exacerbation, calculated by comparing the maximum decline in FEV1 observed during the exacerbation to the baseline FEV1 [(max decline of FEV1 during exacerbation - baseline value of FEV1)/baseline value of FEV1] x100). | The analysis population for this outcome includes participants who experienced 1 or more exacerbations during the study period and for whom FEV1 data was available for analysis. | Posted | Median | Inter-Quartile Range | percentage change from baseline | Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12) |
|
|
|
| Secondary | Percentage Change From Baseline in Nasal IL-1RA (pg/mL) Concentration During Asthma Exacerbation | Nasal epithelial lining fluid (NELF) is collected during a period of wellness (baseline) and daily during acute asthma exacerbation defined by pre-specified criteria for 5 days. This outcome is defined as the percent change from baseline in nasal IL-1RA concentration during acute asthma exacerbation, calculated by comparing the peak concentration observed during the exacerbation to the baseline concentration (i.e., [(peak value of IL-1RA during exacerbation - baseline value of IL-1RA)/baseline value of IL-1RA] x100). Results are summarized using the median and interquartile range. | The analysis population includes participants who experienced 1 or more exacerbations during the study period and for whom NELF samples were available for analysis. | Posted | Median | Inter-Quartile Range | percentage change from baseline | Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12) |
|
|
|
| Secondary | Correlation Over Time Between Percentage Change in Nasal IL-1β Concentration From Baseline and Percentage Change in FEV1 From Baseline During Asthma Exacerbation | Assess the relationship between the asthma exacerbation-induced percentage change from baseline in NELF IL-1β concentrations and the asthma exacerbation-induced percentage change from baseline in FEV1. Pearson's correlation coefficient will be calculated to evaluate the relationship between peak percentage increase in IL-1b levels from baseline and maximum percentage decline in FEV1 from baseline during exacerbation | The analysis population includes participants who experienced 1 or more exacerbations during the study period as well as NELF sample data and FEV1 data during exacerbations. | Posted | Number | correlation coefficient | Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12) |
|
|
|
| 0 |
| 40 |
| 1 |
| 40 |
| 20 |
| 40 |
|
|
| Worsening of asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | An increase in asthma symptoms not requiring treatment with systemic corticosteroids |
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| Influenza | Infections and infestations | Non-systematic Assessment | Symptomatic infection with Influenza |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Post-nasal drip | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Seasonal allergies | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dizziness | General disorders | Non-systematic Assessment | Participant reported feeling dizzy after completing home spirometry. They also reported being out in the heat all day without eating. This event was graded as 'moderate', 'related' to study intervention, and 'expected'. |
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| Fever | Infections and infestations | Non-systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | Non-systematic Assessment | Participant received treatment with ophthalmic antibiotics |
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| Ingrown toenail | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant was instructed by their physician to soak the toe twice daily, apply antibiotic ointment, allow the toenail to grow out and then cut it at a 90 degree angle. |
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| Hand fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Surgery to finger | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | related to finger injury. the participant received Bactrim treatment as well as surgery. |
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| Ankle sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | due to injury, participant was instructed to wear a supportive walking boot for 2 months. |
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| Concussion | Nervous system disorders | Non-systematic Assessment |
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| Finger fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant injured the right ring finger, presented to the ED where the finger was splinted, follow up with orthopedics who recommended buddy taping the fingers. |
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| Mild bleeding with NELF collection | Blood and lymphatic system disorders | Non-systematic Assessment | Mild bleeding during collection of nasal epithelial lining fluid (NELF) that resolved without intervention. Event graded as 'mild', 'related' to study procedures and 'expected'. |
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| Cellulitis | Infections and infestations | Non-systematic Assessment | treated with oral antibiotics |
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| Tonsillar hypertrophy | Immune system disorders | Non-systematic Assessment | Participant required elective surgery to remove tonsils due to tonsillar hypertrophy. |
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| Leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant sought treatment in the ED for a one-week history of leg pain |
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| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
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| Stress fracture of lower leg | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant required treatment with NSAIDs for 1 week. |
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| Sinus infection | Infections and infestations | Non-systematic Assessment | No treatment was given. |
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| GI distress | Gastrointestinal disorders | Non-systematic Assessment | Participant was treated with oral hydration and rest. |
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| Eye injury | Eye disorders | Non-systematic Assessment | treated with ophthalmic antibiotic and lubricating eye drops |
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| COVID-19 | Infections and infestations | Non-systematic Assessment |
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| Hand, foot and mouth disease | Infections and infestations | Non-systematic Assessment |
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| Impetigo | Infections and infestations | Non-systematic Assessment | treated with oral antibiotics |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant experienced wheezing that began after completing spirometry efforts. The participant was treated with 4 puffs of albuterol, and symptoms resolved. The event was graded 'mild', 'related' to study procedures and 'expected'. |
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| Ear infection | Infections and infestations | Non-systematic Assessment | Participant was diagnosed with a viral illness and ear infection. The participant was treated with acetaminophen and ibuprofen only. |
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| Foot pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | The participant was treated with a stabilizing shoe and NSAIDs for pain. The event severity was graded as 'mild' and 'not related' to study interventions or procedures. |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |