Trial Outcomes & Findings for Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents (NCT NCT04748055)
NCT ID: NCT04748055
Last Updated: 2026-06-29
Results Overview
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.
COMPLETED
40 participants
Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)
2026-06-29
Participant Flow
A convenience sample of adolescent and young adult patients receiving asthma specialty care in pulmonology and/or allergy clinics was enrolled at a single institution.
Participant milestones
| Measure |
All Participants
This was an observational study of adolescents and young adults with asthma
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examining Changes in Nasal IL-1 During Acute Asthma Exacerbation in Adolescents
Baseline characteristics by cohort
| Measure |
All Participants
n=40 Participants
This was an observational study of adolescents and young adults with asthma
|
|---|---|
|
Age, Categorical
<=18 years
|
37 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Forced expiratory volume in 1 second (FEV1)
|
98 percent
n=9 Participants
|
|
Interleukin-1b (IL-1b)
|
29.7 picograms per milliliter
n=9 Participants
|
|
Interleukin-1 receptor antagonist (IL-1RA)
|
187397.6 picograms per milliliter
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)Population: The analysis population includes participants who experienced 1 or more exacerbations during the study period and for whom NELF samples were available for analysis.
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.
Outcome measures
| Measure |
All Participants
n=26 Participants
This was an observational study of adolescents and young adults with asthma
|
|---|---|
|
Percentage Change From Baseline in Nasal IL-1β (pg/mL) Concentrations During Asthma Exacerbation
|
171.4 percentage change from baseline
Interval 71.8 to 969.1
|
SECONDARY outcome
Timeframe: Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)Population: The analysis population for this outcome includes participants who experienced 1 or more exacerbations during the study period and for whom FEV1 data was available for analysis.
FEV1 will be measured 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 FEV1 during acute asthma exacerbation, calculated by comparing the maximum decline in FEV1 observed during the exacerbation to the baseline FEV1 \[(max decline of FEV1 during exacerbation - baseline value of FEV1)/baseline value of FEV1\] x100).
Outcome measures
| Measure |
All Participants
n=29 Participants
This was an observational study of adolescents and young adults with asthma
|
|---|---|
|
Percentage Change From Baseline in Forced Expiratory Volume in the First Second (FEV1) in Liters During Asthma Exacerbation
|
-22.4 percentage change from baseline
Interval -28.0 to -12.6
|
SECONDARY outcome
Timeframe: Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)Population: The analysis population includes participants who experienced 1 or more exacerbations during the study period and for whom NELF samples were available for analysis.
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-1RA concentration during acute asthma exacerbation, calculated by comparing the peak concentration observed during the exacerbation to the baseline concentration (i.e., \[(peak value of IL-1RA during exacerbation - baseline value of IL-1RA)/baseline value of IL-1RA\] x100). Results are summarized using the median and interquartile range.
Outcome measures
| Measure |
All Participants
n=26 Participants
This was an observational study of adolescents and young adults with asthma
|
|---|---|
|
Percentage Change From Baseline in Nasal IL-1RA (pg/mL) Concentration During Asthma Exacerbation
|
74.5 percentage change from baseline
Interval 0.2 to 157.6
|
SECONDARY outcome
Timeframe: Baseline and up to 5 days from the time asthma exacerbation is diagnosed (Months 1-12)Population: The analysis population includes participants who experienced 1 or more exacerbations during the study period as well as NELF sample data and FEV1 data during exacerbations.
Assess the relationship between the asthma exacerbation-induced percentage change from baseline in NELF IL-1β concentrations and the asthma exacerbation-induced percentage change from baseline in FEV1. Pearson's correlation coefficient will be calculated to evaluate the relationship between peak percentage increase in IL-1b levels from baseline and maximum percentage decline in FEV1 from baseline during exacerbation
Outcome measures
| Measure |
All Participants
n=26 Participants
This was an observational study of adolescents and young adults with asthma
|
|---|---|
|
Correlation Over Time Between Percentage Change in Nasal IL-1β Concentration From Baseline and Percentage Change in FEV1 From Baseline During Asthma Exacerbation
|
-0.04 correlation coefficient
|
Adverse Events
All Participants
Serious adverse events
| Measure |
All Participants
n=40 participants at risk
This was an observational study of adolescents and young adults with asthma
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
Other adverse events
| Measure |
All Participants
n=40 participants at risk
This was an observational study of adolescents and young adults with asthma
|
|---|---|
|
Infections and infestations
Hand, foot and mouth disease
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Infections and infestations
Impetigo
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Infections and infestations
Ear infection
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
30.0%
12/40 • from enrollment until the final study visit at 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Worsening of asthma
|
12.5%
5/40 • from enrollment until the final study visit at 12 months
|
|
Infections and infestations
Influenza
|
5.0%
2/40 • from enrollment until the final study visit at 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • from enrollment until the final study visit at 12 months
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
General disorders
Fatigue
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Post-nasal drip
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Seasonal allergies
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
5.0%
2/40 • from enrollment until the final study visit at 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.5%
3/40 • from enrollment until the final study visit at 12 months
|
|
General disorders
Dizziness
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Infections and infestations
Fever
|
5.0%
2/40 • from enrollment until the final study visit at 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
4/40 • from enrollment until the final study visit at 12 months
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
3/40 • from enrollment until the final study visit at 12 months
|
|
Gastrointestinal disorders
Nausea
|
5.0%
2/40 • from enrollment until the final study visit at 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
2/40 • from enrollment until the final study visit at 12 months
|
|
Eye disorders
Conjunctivitis
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Skin and subcutaneous tissue disorders
Ingrown toenail
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Musculoskeletal and connective tissue disorders
Hand fracture
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Musculoskeletal and connective tissue disorders
Surgery to finger
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Musculoskeletal and connective tissue disorders
Ankle sprain
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Nervous system disorders
Concussion
|
5.0%
2/40 • from enrollment until the final study visit at 12 months
|
|
Musculoskeletal and connective tissue disorders
Finger fracture
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Blood and lymphatic system disorders
Mild bleeding with NELF collection
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Immune system disorders
Tonsillar hypertrophy
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Ear and labyrinth disorders
Ear pain
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Musculoskeletal and connective tissue disorders
Stress fracture of lower leg
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Infections and infestations
Sinus infection
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Gastrointestinal disorders
GI distress
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Eye disorders
Eye injury
|
2.5%
1/40 • from enrollment until the final study visit at 12 months
|
|
Infections and infestations
COVID-19
|
7.5%
3/40 • from enrollment until the final study visit at 12 months
|
Additional Information
Michelle Hernandez, MD
University of North Carolina Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place