Trial Outcomes & Findings for AQI and Childhood Asthma: an Intervention (NCT NCT04454125)
NCT ID: NCT04454125
Last Updated: 2023-08-31
Results Overview
Moderate and severe asthma exacerbations were captured via questionnaire administered monthly for up to 6 months. Severe and moderate exacerbations were defined by American Thoracic Society (ATS) criteria.
COMPLETED
NA
40 participants
Over study duration (up to 6 months)
2023-08-31
Participant Flow
Participant milestones
| Measure |
Routine Care
Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
|
AQI Intervention
AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Routine Care
Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
|
AQI Intervention
AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
ACT administered to children aged 12 years and older.
Baseline characteristics by cohort
| Measure |
Routine Care
n=20 Participants
Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
|
AQI Intervention
n=20 Participants
AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
12.5 years
STANDARD_DEVIATION 2.6 • n=20 Participants
|
12.5 years
STANDARD_DEVIATION 2.9 • n=20 Participants
|
12.5 years
STANDARD_DEVIATION 2.7 • n=40 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
More than 1 race
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
8 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
At least one severe asthma exacerbation in the past 12 months, yes
|
11 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Asthma Control Test (ACT)
|
20.9 score on a scale
STANDARD_DEVIATION 4.6 • n=13 Participants • ACT administered to children aged 12 years and older.
|
21.2 score on a scale
STANDARD_DEVIATION 3.0 • n=13 Participants • ACT administered to children aged 12 years and older.
|
21.0 score on a scale
STANDARD_DEVIATION 3.8 • n=26 Participants • ACT administered to children aged 12 years and older.
|
|
Childhood Asthma Control Test (CACT)
|
22.6 score on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants • CACT administered to children aged 8-11 years of age
|
20.7 score on a scale
STANDARD_DEVIATION 8.3 • n=7 Participants • CACT administered to children aged 8-11 years of age
|
21.6 score on a scale
STANDARD_DEVIATION 5.8 • n=14 Participants • CACT administered to children aged 8-11 years of age
|
|
Pediatric Asthma Quality of Life Questionnaire
|
5.96 score on a scale
STANDARD_DEVIATION 1.02 • n=20 Participants
|
6.11 score on a scale
STANDARD_DEVIATION 0.84 • n=20 Participants
|
6.03 score on a scale
STANDARD_DEVIATION 0.93 • n=40 Participants
|
|
Body Mass Index z-score (BMIz)
|
1.51 z score
STANDARD_DEVIATION 1.35 • n=20 Participants
|
1.03 z score
STANDARD_DEVIATION 1.22 • n=20 Participants
|
1.27 z score
STANDARD_DEVIATION 1.29 • n=40 Participants
|
|
Reported checking the AQI prior to going outside to be active, yes
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Reported any change in outdoor activity because of the AQI, yes
|
5 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Reported moderate or vigorous activity for at least 10 minutes outside in a typical week, yes
|
14 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Over study duration (up to 6 months)Moderate and severe asthma exacerbations were captured via questionnaire administered monthly for up to 6 months. Severe and moderate exacerbations were defined by American Thoracic Society (ATS) criteria.
Outcome measures
| Measure |
Routine Care
n=20 Participants
Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
|
AQI Intervention
n=20 Participants
AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
|
|---|---|---|
|
Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time
At least one severe asthma exacerbation during study, yes
|
5 Participants
|
4 Participants
|
|
Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time
At least one moderate asthma exacerbation during study, yes
|
13 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Over study duration (up to 6 months)Population: The mean change was obtained, via generalized linear modeling (glm), taking into account the correlation of repeat measures. The values are listed by group and contain all available time points averaged.
Asthma symptom control was measured by the validated Asthma Control Test (ACT) or Childhood Asthma Control Test (CACT) questionnaires as age appropriate (ACT in children 12 year of age or older; CACT for children younger than 12 years of age). ACT and CACT were obtained at baseline and every 4 weeks for up to 6 months. Differences in asthma control scores were compared both within arms and between arms at study end. ACT (min=5, max=25, score of \<=19 concerning for poor asthma control; \<=15 concerning for very poorly controlled). CACT (min=0, max=27, score of \<=19 concerning for poor asthma control; \<=12 concerning for very poorly controlled)
Outcome measures
| Measure |
Routine Care
n=20 Participants
Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
|
AQI Intervention
n=20 Participants
AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
|
|---|---|---|
|
Mean Change in Asthma Control Over Time
Asthma Control Test
|
0.17 score on a scale
Interval -1.17 to 1.51
|
2.02 score on a scale
Interval 0.88 to 3.15
|
|
Mean Change in Asthma Control Over Time
Childhood Asthma Control Test
|
-0.31 score on a scale
Interval -1.87 to 1.25
|
3.96 score on a scale
Interval -1.27 to 9.2
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: 1 participant lost to follow up at exit visit
Quality of life will be measured by the validated Pediatric Asthma Quality of Life Questionnaire with standardized activities (PAQLQ) at entrance and exit visits. Differences in PAQLQ scores will be compared both within arms and between arms at study end. PAQLQ (min=1 (extremely bothered/all the time), max=7 (not bothered/none of the time)
Outcome measures
| Measure |
Routine Care
n=20 Participants
Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
|
AQI Intervention
n=19 Participants
AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
|
|---|---|---|
|
Mean Change in Pediatric Asthma Quality of Life Over Time
|
0.25 score on a scale
Interval -0.06 to 0.55
|
0.54 score on a scale
Interval 0.2 to 0.88
|
SECONDARY outcome
Timeframe: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.Population: 1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.
Participant reported checking of AQI prior to going outside to be active assessed via questionnaire. Question: In the past 4 weeks, did you check the air quality index before going outside to be active? Response choices: Yes, No.
Outcome measures
| Measure |
Routine Care
n=20 Participants
Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
|
AQI Intervention
n=19 Participants
AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
|
|---|---|---|
|
Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.Population: 1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.
Usage of the AQI prior to exercise was monitored monthly via questionnaire. Question: In the past 4 weeks, how many times did you change your outdoor activity because of the air quality index? Response choices: All of the time, Most of the time, Some of the time, A little of the time, None of the time. A positive response was considered an answer of all, most, some, or a little of the time. A negative response was considered none of the time.
Outcome measures
| Measure |
Routine Care
n=20 Participants
Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
|
AQI Intervention
n=19 Participants
AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
|
|---|---|---|
|
Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.Population: 1 participant lost to follow up at exit visit; all participant data (n=40) was included in glm analyses as presented in statistical analyses.
Outcome obtained from physical activity questionnaire. Yes represents a positive response to at least one of the follow two questions: Question 1: In a typical week {do you/does SP} do any vigorous-intensity sports, fitness, or recreational activities that cause large increases in breathing or heart rate like running or basketball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative. Question 2: In a typical week, {do you/does SP} do any moderate-intensity sports, fitness, or recreational activities that cause a small increase in breathing or heart rate such as brisk walking, bicycling, swimming, or volleyball for at least 10 minutes continuously outside? Response choices: Yes, No, Refused, Don't Know. Note: refused and don't know were coded as negative.
Outcome measures
| Measure |
Routine Care
n=20 Participants
Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
|
AQI Intervention
n=19 Participants
AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
|
|---|---|---|
|
Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week
|
9 Participants
|
7 Participants
|
Adverse Events
Routine Care
AQI Intervention
Serious adverse events
| Measure |
Routine Care
n=20 participants at risk
Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
|
AQI Intervention
n=20 participants at risk
AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation requiring hospitalization
|
10.0%
2/20 • Number of events 2 • Adverse events were monitored during the 6 month study duration.
Asthma is a chronic lung disease with varying impairment and risk, thus asthma exacerbations and loss of control are not unexpected. However, if a participant reported 3 severe asthma exacerbations, 3 consecutive control test scores \<=19, or had FEV1 \<80% at either visit, these were recorded, the parent was notified, and follow-up with managing asthma specialist was recommended. Hospitalizations for asthma were considered expected, serious adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse events were monitored during the 6 month study duration.
Asthma is a chronic lung disease with varying impairment and risk, thus asthma exacerbations and loss of control are not unexpected. However, if a participant reported 3 severe asthma exacerbations, 3 consecutive control test scores \<=19, or had FEV1 \<80% at either visit, these were recorded, the parent was notified, and follow-up with managing asthma specialist was recommended. Hospitalizations for asthma were considered expected, serious adverse events.
|
Other adverse events
| Measure |
Routine Care
n=20 participants at risk
Routine care: The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
|
AQI Intervention
n=20 participants at risk
AQI intervention: The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Three consecutive poor control scores
|
15.0%
3/20 • Adverse events were monitored during the 6 month study duration.
Asthma is a chronic lung disease with varying impairment and risk, thus asthma exacerbations and loss of control are not unexpected. However, if a participant reported 3 severe asthma exacerbations, 3 consecutive control test scores \<=19, or had FEV1 \<80% at either visit, these were recorded, the parent was notified, and follow-up with managing asthma specialist was recommended. Hospitalizations for asthma were considered expected, serious adverse events.
|
5.0%
1/20 • Adverse events were monitored during the 6 month study duration.
Asthma is a chronic lung disease with varying impairment and risk, thus asthma exacerbations and loss of control are not unexpected. However, if a participant reported 3 severe asthma exacerbations, 3 consecutive control test scores \<=19, or had FEV1 \<80% at either visit, these were recorded, the parent was notified, and follow-up with managing asthma specialist was recommended. Hospitalizations for asthma were considered expected, serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Three severe asthma exacerbations
|
10.0%
2/20 • Adverse events were monitored during the 6 month study duration.
Asthma is a chronic lung disease with varying impairment and risk, thus asthma exacerbations and loss of control are not unexpected. However, if a participant reported 3 severe asthma exacerbations, 3 consecutive control test scores \<=19, or had FEV1 \<80% at either visit, these were recorded, the parent was notified, and follow-up with managing asthma specialist was recommended. Hospitalizations for asthma were considered expected, serious adverse events.
|
0.00%
0/20 • Adverse events were monitored during the 6 month study duration.
Asthma is a chronic lung disease with varying impairment and risk, thus asthma exacerbations and loss of control are not unexpected. However, if a participant reported 3 severe asthma exacerbations, 3 consecutive control test scores \<=19, or had FEV1 \<80% at either visit, these were recorded, the parent was notified, and follow-up with managing asthma specialist was recommended. Hospitalizations for asthma were considered expected, serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Low FEV1
|
10.0%
2/20 • Adverse events were monitored during the 6 month study duration.
Asthma is a chronic lung disease with varying impairment and risk, thus asthma exacerbations and loss of control are not unexpected. However, if a participant reported 3 severe asthma exacerbations, 3 consecutive control test scores \<=19, or had FEV1 \<80% at either visit, these were recorded, the parent was notified, and follow-up with managing asthma specialist was recommended. Hospitalizations for asthma were considered expected, serious adverse events.
|
15.0%
3/20 • Adverse events were monitored during the 6 month study duration.
Asthma is a chronic lung disease with varying impairment and risk, thus asthma exacerbations and loss of control are not unexpected. However, if a participant reported 3 severe asthma exacerbations, 3 consecutive control test scores \<=19, or had FEV1 \<80% at either visit, these were recorded, the parent was notified, and follow-up with managing asthma specialist was recommended. Hospitalizations for asthma were considered expected, serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place