AsthmaAttack AsthmaNCT04748055
Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents
An observational study of Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Asthma
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2021to 8 Feb 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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,
Show all 17Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Keywords
- Asthma in children, Asthma attack
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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
Measured: Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start27 Jul 2021
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Allison Burbank, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748055
- Sponsor's protocol ID
- 20-2452
- Other IDs
- R01HL135235
- Acronym
- Attack Asthma
- Status last verified
- Oct 2023
- First submitted
- 5 Feb 2021
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 17983880
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents
- ClinicalTrials.gov ID
- NCT04748055
- Acronym / sponsor ID
- Attack Asthma / 20-2452
- Conditions
- Asthma
- Keywords
- Asthma in children, Asthma attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Posted 29 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (17 listed)
- 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):
- Daytime symptoms >2x/week?
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage Change From Baseline in Nasal IL-1β (pg/mL) Concentrations During Asthma Exacerbation
Time frame: Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)
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.
3 secondary outcomes
Percentage Change From Baseline in Forced Expiratory Volume in the First Second (FEV1) in Liters During Asthma Exacerbation
Time frame: 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
Time frame: 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
Time frame: Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17983880National 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.
- Individual participant dataSharing planned: Yes. 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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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Burbank, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change From Baseline in Nasal IL-1β (pg/mL) Concentrations During Asthma Exacerbation (time frame: Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04748055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.