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Nasal clues could unlock new asthma attack treatment

NCT ID NCT04748055

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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