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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Over study duration (up to 6 months)

Results posted on

2023-08-31

Participant Flow

Participant milestones

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

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

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

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

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 months

Population: 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

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

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

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

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

Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths

AQI Intervention

Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

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

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

Dr. Franziska Rosser

University of Pittsburgh

Phone: 412-692-8429

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place