NCT04454125

AQI and Childhood Asthma: an Intervention

Completed NA Results posted Last updated 31 August 2023

What this trial tests

NA trial testing AQI intervention in Asthma in 40 participants. Completed in 22 March 2021.

Timeline

14 July 2020

Primary endpoint
22 March 2021

22 March 2021

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	14 July 2020
Primary completion	22 March 2021
Estimated completion	22 March 2021
Sites	1 location across United States

Drugs / interventions tested

• AQI intervention
• Routine care

Conditions studied

• Asthma — all drugs for Asthma →
• Asthma in Children — all drugs for Asthma in Children →

Sponsor

University of Pittsburgh

Who can join

Adults 8 to 17, any sex, with Asthma or Asthma in Children. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time Primary · 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.

At least one severe asthma exacerbation during study, yes

Group	Value	95% CI
Routine Care	5
AQI Intervention	4

At least one moderate asthma exacerbation during study, yes

Group	Value	95% CI
Routine Care	13
AQI Intervention	12

Mean Change in Asthma Control Over Time Primary · Over study duration (up to 6 months)

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

Asthma Control Test

Group	Value	95% CI
Routine Care	0.17	-1.17 – 1.51
AQI Intervention	2.02	0.88 – 3.15

Childhood Asthma Control Test

Group	Value	95% CI
Routine Care	-0.31	-1.87 – 1.25
AQI Intervention	3.96	-1.27 – 9.20

Mean Change in Pediatric Asthma Quality of Life Over Time Primary · Baseline, 6 months

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)

Group	Value	95% CI
Routine Care	0.25	-0.06 – 0.55
AQI Intervention	0.54	0.20 – 0.88

Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active Secondary · Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.

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.

Group	Value	95% CI
Routine Care	3
AQI Intervention	12

Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI Secondary · Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.

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.

Group	Value	95% CI
Routine Care	2
AQI Intervention	7

Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week Secondary · Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.

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 th

Group	Value	95% CI
Routine Care	9
AQI Intervention	7

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were monitored during the 6 month study duration.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Routine Care

Serious: 2/20 (10%)

Deaths: 0/20

AQI Intervention

Serious: 1/20 (5%)

Deaths: 0/20

Serious adverse events (1 terms)

Reaction	System	Routine Care	AQI Intervention
Asthma exacerbation requiring hospitalization	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Routine Care	AQI Intervention
Three consecutive poor control scores	Respiratory, thoracic and mediastinal disorders	—	—
Low FEV1	Respiratory, thoracic and mediastinal disorders	—	—
Three severe asthma exacerbations	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Asthma exacerbation requiring hospitalization.

Data from ClinicalTrials.gov NCT04454125 adverse events section.

Sponsor's own description

This is a small pilot prospective intervention trial in children with asthma who will be randomized to receive either (A) Air Quality Index (AQI) education + an asthma action plan (control) or (B) AQI education + an asthma action plan which contains AQI behavioral recommendations + demonstrate ability to navigate to AirNow either online or on smartphone app (intervention).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.