Status:
COMPLETED
Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
12-21 years
Brief 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 timin...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 8 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04748055
Start Date
July 27 2021
End Date
February 8 2024
Last Update
May 10 2024
Active Locations (1)
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1
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27514