AsthmaNCT04454125

AQI and Childhood Asthma: an Intervention

A study testing AQI intervention and Routine care in people with Asthma and Asthma in Children, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 8 to 17 years
Conditions the study is for: Asthma, Asthma in Children
What is being tested?: AQI intervention and Routine care
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 14 Jul 2020to 22 Mar 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Child Inclusion criteria includes:
physician diagnosis of persistent asthma- either mild, moderate, or severe;
family home internet access and/or smartphone access + willingness to download AirNow app on phone;
age 8-17 years.
Parent/guardian inclusion: parent or guardian of the child participant, of whom has met inclusion criteria.

Who cannot join

Child exclusion criteria includes:
diagnosis of other chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary dysplasia, etc)
immunodeficiency- acquired or congenital
neuromuscular disease
disability affecting ambulation
cyanotic congenital heart disease

Show all 9Show fewer

only 1 child per household eligible
no plans to leave Pittsburgh area in next 6 months
Parental/guardian exclusion criteria: none.

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

Official title: Air Quality Index (AQI) and Childhood Asthma: an Intervention

Read the detailed description

Over 3 million US children with asthma reported at least one attack in the prior year. Poorly controlled asthma is a major cause of suffering, school absences, loss of caregiver productivity, and healthcare costs (estimated as ~$80 billion/year). Over half of children on controller medication are not well controlled, due to environmental exposures, non-adherence, or true non-response to treatment. Outdoor air pollution is a known trigger of asthma. Although sound health policies are the best long-term approaches to reduce the harmful effects of air pollution, exposure avoidance is needed until "clean air" is ensured through effective legislation. Despite this, healthcare providers infrequently provide pollution exposure advice to children with asthma. The Environmental Protection Agency (EPA) monitors air pollution and reports a daily Air Quality Index (AQI) that is easy to use and available in most metropolitan areas. Practical recommendations regarding outdoor activity can be based on AQI levels. Despite this, AQI-based recommendations are rarely addressed in asthma action plans (AAP). No pediatric study has assessed the addition of the AQI to AAP to reduce asthma morbidity. This proposal seeks to recruit a pilot cohort of 40 children with asthma. Using this cohort, the investigators will test the hypotheses that (1) the addition of the AQI to AAP will reduce asthma exacerbations and (2) the addition of the AQI to AAP will improve asthma symptom control \& quality of life in children with asthma. The inclusion of the AQI onto asthma action plans is novel in clinical asthma care; its wide availability would make large-scale implementation feasible. The investigators expect this low-cost and low-tech intervention will have a positive impact in reducing asthma morbidity. Given that 1 out of every 12 children in the U.S. has asthma, this is relevant to health care professionals, parents, and public health practitioners.

Optional, the investigators will collect nasal epithelial cells for use in future genomic/epigenetic studies.

Additionally, 40 parents/guardians of the children were also recruited to complete a baseline parental knowledge and usage of the AQI questionnaire administered at the randomization visit. This was originally listed as a secondary outcome however was removed during reporting of results as parental knowledge is not a true clinical trial outcome. Also, the secondary outcome of baseline child AQI usage (checking AQI) was changed to reflect this was a measure collected at all study visits and the secondary measure of physical activity was added.

Conditions: Asthma, Asthma in Children
Being tested: AQI intervention, Routine care
Keywords: Air Quality Index (AQI), Childhood asthma exacerbations
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AQI interventionBehavioural
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).
Routine careOther
The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.

Study groups in NCT04454125
Study group	Role	What they receive
Routine Care	Active comparator	Not described Receives: Other: Routine care
AQI Intervention	Experimental	Not described Receives: Behavioral: AQI intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time
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.
Measured: Over study duration (up to 6 months)
Mean Change in Asthma Control Over Time
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)
Measured: Over study duration (up to 6 months)
Mean Change in Pediatric Asthma Quality of Life Over Time
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)
Measured: Baseline, 6 months

Secondary outcomes (3)

Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active
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.
Measured: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI
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.
Measured: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week
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.
Measured: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 202022 Mar 2021

First posted1 Jul 2020
Study start14 Jul 2020
Primary completion22 Mar 2021
Study completion22 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 40 child will be 1:1 randomization by age groups 8-12 years, 13-17 years.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04454125
Sponsor's protocol ID: STUDY19120083
Status last verified: Aug 2023
First submitted: 26 Jun 2020
Last updated: 31 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The investigators do not currently have an individual participant data sharing plan. However, de-identified research data/documents may be shared in the future with other investigators who share similar research interests. Specimens and data will not be released without (1) PI written permission and (2) appropriate Institutional Review Board (IRB) approval. Data use and/or material transfer agreements will also be required as applicable to outside researchers.

Publications

Reyes-Angel J, Han YY, Forno E, Celedon JC, Rosser FJ. Parental knowledge and usage of air quality in childhood asthma management. Front Pediatr. 2022 Oct 26;10:966372. doi: 10.3389/fped.2022.966372. eCollection 2022.
PubMed 36440347
Rosser FJ, Rothenberger SD, Han YY, Forno E, Celedon JC. Air Quality Index and Childhood Asthma: A Pilot Randomized Clinical Trial Intervention. Am J Prev Med. 2023 Jun;64(6):893-897. doi: 10.1016/j.amepre.2022.12.010. Epub 2023 Jan 13.
PubMed 36642643

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Air Quality Index (AQI) and Childhood Asthma: an Intervention
ClinicalTrials.gov ID: NCT04454125
Acronym / sponsor ID: STUDY19120083
Conditions: Asthma, Asthma in Children
Keywords: Air Quality Index (AQI), Childhood asthma exacerbations
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: American Thoracic Society
Study start: 14 Jul 2020 (actual)
Primary completion: 22 Mar 2021 (actual)
Study completion: 22 Mar 2021 (actual)
First posted: 1 Jul 2020 (actual)
Results: Posted 15 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Optional, the investigators will collect nasal epithelial cells for use in future genomic/epigenetic studies.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 40 child will be 1:1 randomization by age groups 8-12 years, 13-17 years.

Arm	Type	Receives
Routine Care	Active comparator	Other: Routine care
AQI Intervention	Experimental	Behavioral: AQI intervention

Who may qualify

Ages: 8 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Child Inclusion criteria includes:
Parent/guardian inclusion: parent or guardian of the child participant, of whom has met inclusion criteria.

Key exclusion criteria (9 listed)

Child exclusion criteria includes:
Parental/guardian exclusion criteria: none.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AQI interventionThe 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).	Behavioural	AQI Intervention
Routine careThe routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.	Other	Routine Care

Primary outcome

Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time
Time frame: 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.
Mean Change in Asthma Control Over Time
Time frame: 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 control; <=12 concerning for very poorly controlled)
Mean Change in Pediatric Asthma Quality of Life Over Time
Time frame: 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)

3 secondary outcomes

Number of Participants Who Reported Checking the AQI Prior to Going Outside to be Active
Time frame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
Number of Participated Who Reported Outdoor Activity Behavioral Change in Response to the AQI
Time frame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.
Number of Participants Who Reported Moderate or Vigorous Physical Activity for at Least 10 Minutes Continuously Outside in a Typical Week
Time frame: Over study duration, assessed at baseline and monthly during study for up to 6 months. Reported below at exit.

Results and safety

Results posted to the registry on 15 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Routine Care	20	20
AQI Intervention	20	19

Primary outcome: Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time

Time frame: Over study duration (up to 6 months). Count of participants. Unit: Participants

Measure	Routine Care n = 20	AQI Intervention n = 20
At least one severe asthma exacerbation during study, yes	5	4
At least one moderate asthma exacerbation during study, yes	13	12

Routine Care vs AQI Intervention: Odds Ratio (OR): 0.61 (95% CI 0.23 to 1.61), p = 0.32, Generalized linear model, repeat measure
Routine Care vs AQI Intervention: Odds Ratio (OR): 0.31 (95% CI 0.03 to 2.76), p = 0.29, generalized linear model, repeat measure
Routine Care vs AQI Intervention: Odds Ratio (OR): 0.51 (95% CI 0.05 to 5.68), p = 0.58, generalized linear model, repeat measure

Primary outcome: Mean Change in Asthma Control Over Time

Time frame: Over study duration (up to 6 months). Mean (95% Confidence Interval). Unit: score on a scale

Measure	Routine Care n = 20	AQI Intervention n = 20
Asthma Control Test	0.17 (-1.17 to 1.51)	2.02 (0.88 to 3.15)
Childhood Asthma Control Test	-0.31 (-1.87 to 1.25)	3.96 (-1.27 to 9.20)

Routine Care vs AQI Intervention: Mean Difference (Net): 0.17 (95% CI -1.17 to 1.51), p = 0.80, generalized linear model, repeat measure
Routine Care vs AQI Intervention: Mean Difference (Net): 2.02 (95% CI 0.88 to 3.15), p = 0.001, generalized linear model, repeat measure
Routine Care vs AQI Intervention: Mean Difference (Net): 1.85 (95% CI 0.09 to 3.61), p = 0.04, generalized linear model, repeat measure

Population analysed: 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.

Primary outcome: Mean Change in Pediatric Asthma Quality of Life Over Time

Time frame: Baseline, 6 months. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Routine Care n = 20	AQI Intervention n = 19
Value	0.25 (-0.06 to 0.55)	0.54 (0.20 to 0.88)

Routine Care vs AQI Intervention: Mean Difference (Net): 0.25 (95% CI -0.06 to 0.55), p = 0.11, generalized linear model, repeat measure
Routine Care vs AQI Intervention: Mean Difference (Net): 0.54 (95% CI 0.20 to 0.88), p = 0.002, generalized linear model, repeat measure
Routine Care vs AQI Intervention: Mean Difference (Net): 0.30 (95% CI -0.16 to 0.75), p = 0.20, generalized linear model, repeat measure

Population analysed: 1 participant lost to follow up at exit visit

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored during the 6 month study duration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Routine Care	2 of 20 (10%)	3 of 20 (15%)	0 of 20
AQI Intervention	1 of 20 (5%)	4 of 20 (20%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36440347Reyes-Angel J, Han YY, Forno E, Celedon JC, Rosser FJ. Parental knowledge and usage of air quality in childhood asthma management. Front Pediatr. 2022 Oct 26;10:966372. doi: 10.3389/fped.2022.966372. eCollection 2022.
Results publication: PubMed 36642643Rosser FJ, Rothenberger SD, Han YY, Forno E, Celedon JC. Air Quality Index and Childhood Asthma: A Pilot Randomized Clinical Trial Intervention. Am J Prev Med. 2023 Jun;64(6):893-897. doi: 10.1016/j.amepre.2022.12.010. Epub 2023 Jan 13.
Individual participant dataSharing planned: No. The investigators do not currently have an individual participant data sharing plan. However, de-identified research data/documents may be shared in the future with other investigators who share similar research interests. Specimens and data will not be released without (1) PI written permission and (2) appropriate Institutional Review Board (IRB) approval. Data use and/or material transfer agreements will also be required as applicable to outside researchers.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Franziska Rosser, MD MPH principal investigator

UPMC | Children's Hospital of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AQI intervention and Routine care in people with Asthma and Asthma in Children, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With at Least One Moderate or Severe Asthma Exacerbation Over Time (time frame: Over study duration (up to 6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04454125, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.