Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents (NCT04748055) | Clinical Trial Compass
CompletedNot Applicable
Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents
United States40 participantsStarted 2021-07-27
Plain-language 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. This information will allow the investigators to estimate effect size and guide decisions about the optimal timing of anakinra administration for the future study.
Who can participate
Age range12 Years – 21 Years
SexALL
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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):
* 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…
What they're measuring
1
Change from baseline in Nasal IL-1β (pg/mL) Concentrations over time during Asthma Exacerbation
Timeframe: Baseline and up to 5 days from the time asthma exacerbation is diagnosed