Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents

NCT04748055 | Completed Results

• 2 other identifiers: 20-2452R01HL135235
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Asthma

Keywords

Asthma in children; Asthma attack

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Nasal IL-1β (pg/mL) Concentrations During Asthma Exacerbation

  Nasal epithelial lining fluid (NELF) is collected during a period of wellness (baseline) and daily during acute asthma exacerbation (defined by pre-specified criteria) for 5 days. This outcome is defined as the percent change from baseline in nasal IL-1β concentration during acute asthma exacerbation, calculated by comparing the peak concentration observed during the exacerbation to the baseline concentration (i.e., \[(peak value of IL-1β during exacerbation - baseline value of IL-1β)/baseline value of IL-1β\] x100). Results are summarized using the median and interquartile range.

  Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)

Secondary Outcomes (3)

• Percentage Change From Baseline in Forced Expiratory Volume in the First Second (FEV1) in Liters During Asthma Exacerbation

  Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)

• Percentage Change From Baseline in Nasal IL-1RA (pg/mL) Concentration During Asthma Exacerbation

  Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)

• Correlation Over Time Between Percentage Change in Nasal IL-1β Concentration From Baseline and Percentage Change in FEV1 From Baseline During Asthma Exacerbation

  Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.

  PMID: 17983880 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

NELF

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Michelle Hernandez, MD
• Organization: University of North Carolina Chapel Hill

michelle_hernandez@med.unc.edu

9199625136

Study Officials

• Allison Burbank, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: July 27, 2021
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: June 29, 2026
• Results First Posted: June 29, 2026

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• Access Criteria: Approved IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)