- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04748055
Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents (Attack Asthma)
October 3, 2023 updated by: University of North Carolina, Chapel Hill
A Pilot Study Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents
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.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katie Mills
- Phone Number: 919-966-2936
- Email: katherine.mills@unc.edu
Study Locations
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- University of North Carolina - Chapel Hill
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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):
- Asthma Control Test (ACT) score <20,
- FEV1 <80% of predicted,
- Meets Global Initiative on Asthma (GINA) criteria for partly controlled or uncontrolled asthma (2):
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
- Access to a smartphone
- Wireless internet access in the participant's home
- Access to a standard freezer in the home
Exclusion Criteria:
- Systemic corticosteroid-dependent asthma (i.e. people who take oral steroids such as prednisone daily for asthma control). Use of other immunomodulator medications (such as biologics for asthma like omalizumab, etc) is allowable so long as the participant has been on a stable dose of the medication for at least 3 months.
- Participants whose asthma is sufficiently severe that the participants routinely require rescue albuterol multiple times a day for symptom relief (not including pre-exercise albuterol use).
- Pulmonary disease other than asthma that in the opinion of investigators may affect the interpretation of spirometry data, including but not limited to vocal cord dysfunction, restrictive lung disease, or cystic fibrosis.
- Inability to perform spirometry.
- History of spirometry-induced bronchoconstriction.
- Pregnancy or nursing a baby. Due to the effect of hormonal changes of pregnancy/lactation on airway inflammation, participants who are pregnant or nursing will be excluded from study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Nasal IL-1β (pg/mL) Concentrations over time during Asthma Exacerbation
Time Frame: Baseline and up to 5 days from the time asthma exacerbation is diagnosed
|
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.
The change from baseline in nasal IL-1β concentrations during acute asthma exacerbation will be measured for each of the 5 days of the exacerbation to measure the degree of change over time and to identify the timing of peak IL-1β concentration.
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Baseline and up to 5 days from the time asthma exacerbation is diagnosed
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Forced Expiratory Volume in the First Second (FEV1) Percent (%) Predicted over time during Asthma Exacerbation
Time Frame: Baseline and up to 5 days from the time asthma exacerbation is diagnosed
|
FEV1 will be measured during a period of wellness (baseline) and daily during acute asthma exacerbation defined by pre-specified criteria for 5 days.
The change from baseline in FEV1 % predicted during asthma exacerbation will be measured for each of the 5 days of the exacerbation to determine the degree of change over time.
|
Baseline and up to 5 days from the time asthma exacerbation is diagnosed
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Change from Baseline in Nasal Concentrations of Other Relevant Inflammatory Cytokines/Chemokines over time during Asthma Exacerbation
Time Frame: Baseline and up to 5 days from the time asthma exacerbation is diagnosed
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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.
The change from baseline in nasal cytokine and chemokine concentrations during acute asthma exacerbation will be measured for each of the 5 days of the exacerbation to determine the degree of change over time.
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Baseline and up to 5 days from the time asthma exacerbation is diagnosed
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Correlation over time Between Changes in Nasal IL-1β Concentration from Baseline and Changes in FEV1 % Predicted from Baseline during Asthma Exacerbation
Time Frame: Baseline and up to 5 days from the time asthma exacerbation is diagnosed
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Assess the relationship over time between the asthma exacerbation-induced change in NELF IL-1β concentrations and the asthma exacerbation-induced change in FEV1% predicted.
The correlation will be calculated for each of the 5 days of the exacerbation to determine the degree of change over time.
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Baseline and up to 5 days from the time asthma exacerbation is diagnosed
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Allison Burbank, MD, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 27, 2021
Primary Completion (Estimated)
February 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
February 5, 2021
First Submitted That Met QC Criteria
February 5, 2021
First Posted (Actual)
February 10, 2021
Study Record Updates
Last Update Posted (Actual)
October 5, 2023
Last Update Submitted That Met QC Criteria
October 3, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-2452
- R01HL135235 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing Access Criteria
Approved IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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