NCT04748055Completed
Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents
A Pilot Study Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 40 (actual)
- First submitted
- 5 Feb 2021
- Start date
- 27 Jul 2021
- Primary completion date
- 8 Feb 2024
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Asthma
- NCT number
- NCT04748055
What you commit to
- Study type: Observational
- Participants enrolled: 40
- From 27 Jul 2021 to the primary completion date, 8 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- History of spirometry-induced bronchoconstriction.
Other
- 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).
- Inability to perform spirometry.
- 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.
Who the study is looking for
- 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
Age in the registry: 12 years to 21 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.