Nasal clues could unlock new asthma attack treatment
NCT ID NCT04748055
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This pilot study tracks changes in a specific inflammatory marker (IL-1β) in the nasal passages of adolescents during an asthma attack. Researchers collect nasal fluid samples daily for five days during an attack and compare them to baseline samples taken when the participant is well. The goal is to understand when IL-1β peaks, which could help determine the best time to give a drug called anakinra in future studies. Participants are teens aged 12–21 with persistent asthma who use daily controller medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help design a future trial testing anakinra (a drug that blocks IL-1) to reduce inflammation during asthma attacks.
- What could go wrong
- This is a small pilot study with only 40 participants, focused on measuring biological changes rather than testing a treatment. Results may not lead to a successful therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
40 people
The number who actually took part.
- Started
-
Jul 2021
- Finished
-
Feb 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
-
12 to 21 years
- Sex
-
Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Asthma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27514, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple breath test cut asthma Flare-Ups?
- Breathing tests face off: can extra lung measurements improve asthma diagnosis?
- The carbon label on your inhaler: can it sway a Doctor's choice?
- Six biologics put to the test in Real-World asthma and COPD care
- Can a digital program help teens with chronic illnesses move to adult care?
- Why do some kids catch every cold? a 1,200-Child study hunts for immune clues