AsthmaNCT04891978
US PRECISION Implementation Study
A study testing AIRQ, Asthma Checklist and PRECISION Program (Educational Resources) in people with Asthma, run by AstraZeneca at 13 sites in United States.
Trial summary
The primary objective of this community program intervention study is to assess the process and potential benefits of integrating the AIRQ®, Asthma Checklist, and educational resources (PRECISION program) into clinical practice using either in-person or telehealth visits. Read more about this study
- Who is it for?
- Ages 13 to 130 years
- Conditions the study is for
- Asthma
- What is being tested?
- AIRQ, Asthma Checklist and PRECISION Program (Educational Resources)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 857 participants
- Where
- 13 sitesUnited States
- Study dates
- 20 Apr 2021to 30 Apr 2023
- 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 13 to 130 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- >= 13 years of age at the time of enrollment
- Diagnosis of HCP-confirmed asthma
- Able to read, understand and speak English or Spanish sufficiently self-complete or be administered the AIRQ via telephone, desktop, or mobile device (e.g., smartphone, iPad)
- Provide consent (adults/parents/guardians) and assent (age 13-17 years) to participate in the study.
Who cannot join
- Current diagnosis of active COPD or any lower respiratory diagnosis other than asthma
- Has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, or insufficient knowledge of the English or Spanish language that, in the opinion of the investigator, would interfere with his or her ability to agree to participate and/or complete the AIRQ or other study questionnaires
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
Asheville, North Carolina, 28801
Research Site
Birmingham, Alabama, 35209
Research Site
Charleston, West Virginia, 25304
Research Site
Cornwall-on-Hudson, New York, 12518
Research Site
Fort Wayne, Indiana, 46802
Research Site
Honolulu, Hawaii, 96819
Research Site
Leesburg, Florida, 34748
Research Site
Philadelphia, Pennsylvania, 19148
Research Site
Rochester, New York, 14607
Research Site
San Antonio, Texas, 78249
Research Site
Tewksbury, Massachusetts, 01876
Research Site
Vienna, Virginia, 22182
About this study
Official title: Implementation of the US PRECISION AIRQ, Asthma Checklist, and Educational Resources (PRECISION Program) Into Clinical Practice Using Telehealth and In-Person Platforms
The primary objective of this community program intervention study is to assess the process and potential benefits of integrating the AIRQ®, Asthma Checklist, and educational resources (PRECISION program) into clinical practice using either in-person or telehealth visits.
The secondary objectives are to assess asthma patients' clinic visit experiences when the AIRQ, the Asthma Checklist, and educational resources (PRECISION program) are utilized as part of a telehealth or in-person visit with their HCP, and to explore change in AIRQ scores from the initial visit to follow-up visit(s) (when available).
Read the detailed description
This community program intervention study will examine the process of integrating the AIRQ, Asthma Checklist, and educational resources (PRECISION program) into clinical practice using either in-person or telehealth visits. Providers use of patients' responses to the AIRQ, Asthma Checklist, and educational resources to guide treatment and asthma work-up and management also will be examined. The study duration is 12-months, with study enrollment lasting nine (9) months for each site (implementation stage), and an additional three (3) months of follow-up to assess the sustainability of using the PRECISION program in clinical practice (sustainability stage). The nine-month implementation stage will allow for the recruitment of approximately 50 patients at each site (maximum of 75 patients at each site) for an initial study visit, plus the potential for follow-up visit(s). The three-month sustainability stage will allow for sites to continue to implement the PRECISION program in their clinical practice and for sites to describe any continued benefits of using the PRECISION program at their site.
Approximately fifteen (15) to twenty (20) clinical sites will be recruited to participate in this study, categorized into the following four practice clusters: (1) primary care site (e.g., private practice, FQHC; (2) specialty care site (pulmonary, asthma/immunology); and (3) novel sites (e.g., pharmacy, nurse practitioners, nurse educators, prescribers and Non-prescribers, telehealth component of Allergy and Asthma Network. While all sites will be able to conduct both in-person and telehealth visits, sites will aim to conduct a minimum of approximately 25% of their initial patient visit using a telehealth platform. Both platforms (in-person and telehealth) can be used for the follow-up visit(s) for all practice types.
- Conditions
- Asthma
- Being tested
- AIRQ, Asthma Checklist, PRECISION Program (Educational Resources)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIRQBehavioural
A validated tool designed to identify patients who may be at risk for adverse outcomes from uncontrolled asthma.
Asthma ChecklistBehavioural
A validated, 3-page tool, based on GINA and NAEPP guidelines to assist providers with recognition, evaluation, and optimization of all patients with asthma. In this study, healthcare providers will be required to complete the assess component (page 1) of the Asthma Checklist .
PRECISION Program (Educational Resources)Behavioural
Educational resources accessible to all providers in the study. There are provider-facing and patient-facing educational materials that can be accessed during the patient visit or as resources for before/after visits. Resources can be downloaded and sent to patients per the discretion of providers.
| Study group | Role | What they receive |
|---|---|---|
| AIRQ, Asthma Checklist, and PRECISION Program | Experimental | All participants in the trial will be given the behavioral interventions which include the AIRQ tool, the Asthma Checklist tool, and the PRECISION program educational resources. Receives: Behavioral: AIRQ; Behavioral: Asthma Checklist; Behavioral: PRECISION Program (Educational Resources) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Overall Ease of Implementing AIRQ Into Clinical Practice.
The post-study HCP survey includes questions regarding the implementation of the PRECISION program (e.g., how would you rate the overall ease of implementing the AIRQ into your clinical practice using the telehealth platform?)
Measured: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to How Much the AIRQ Helped Manage Patients
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., Did AIRQ help you manage your patients?)
Measured: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Whether the AIRQ Helped Identify Patients at Risk for Adverse Asthma Health Outcomes
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., Did AIRQ help you identify patients who were at risk for adverse health outcomes from their asthma that you would have otherwise missed?)
Measured: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Most and Least Helpful Parts of AIRQ
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., What did you find most useful about AIRQ?)
Measured: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Frequency of Referring to a Specialist or Practice Type Different Than Their Own While Using the AIRQ
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., While using AIRQ how often did you refer to a specialist or practice type different than your own?)
Measured: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Components of Care Improved by AIRQ
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., Did AIRQ improve any of the following?)
Measured: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Importance of Using Different Components of the PRECISION Program
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., How important was it for you to use the Assess component of the Asthma Checklist (page 1) with the AIRQ?).
Measured: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
Average Number of Patients Treated Using the PRECISION Program at Each Site as Reported by Site HCPs by Site Type
The post-study HCP survey asks sites to report the number of patients treated using the PRECISION program at their site. One HCP per site reported on the number of patients treated using the PRECISION program at their site. The mean presented is the number of patients at each site as reported by site HCPs divided by the number of sites.
Measured: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Primary Care Sites
On the post-study survey, one HCP per site (site PI) was asked to describe the features of the PRECISION program they thought were the most useful and could be improved when implemented at their site
Measured: Post-study survey was completed between 32.9 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Specialty Care Sites
On the post-study survey, one HCP per site (site PI) was asked to describe the features of the PRECISION program they thought were most useful and could be improved when implemented at their site
Measured: Post-study survey was completed between 22.1 weeks and 50.4 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Novel Care Site
On the post-study survey, one HCP per site (site PI) was asked to describe the features of the PRECISION program they thought were most useful and could be improved when implemented at their site
Measured: Post-study survey was completed 5 weeks after last patient end of follow-up; end of follow up was 6 weeks from last patient enrolled at site.
Descriptive Free-text Clinician Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Primary Care Sites
Site clinicians were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Measured: Post-study clinician interviews were completed between -2 weeks (interviews completed a little sooner than end of follow-up) and 52.4 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Primary Care Sites
Key site staff were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Measured: Post-study key site staff interviews were completed between -2 weeks (interviews completed a little sooner than end of follow-up) and 43 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Descriptive Free-text Clinician Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Specialty Care Sites
Site clinicians were asked to respond to several open-ended interview questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Measured: Post-study clinician interviews were completed between -6.3 weeks (interviews completed a little sooner than end of follow-up) and 23 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Specialty Care Sites
Key site staff were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Measured: Post-study site staff interviews were completed between -6.3 weeks (interviews completed a little sooner than end of follow-up) and 4.7 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Descriptive Free-text HCP Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Novel Site
Site HCPs were asked to respond to several open-ended interview questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Measured: Post-study HCP interviews were completed 5 weeks after last patient end of follow-up; end of follow up was 6 weeks from last patient enrolled at site.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Novel Site
Key site staff were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Measured: Post-study key site staff interviews were completed 5 weeks after last patient end of follow-up; end of follow up was 6 weeks from last patient enrolled at site.
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Primary Care Sites (Month 1)
At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)
Measured: Month 1 after start of implementation
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Primary Care Sites (Month 2)
At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)
Measured: Month 2 after start of implementation
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Specialty Care Sites (Month 1)
At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)
Measured: Month 1 after start of implementation
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Novel Care Site (Month 2)
At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)
Measured: Month 2 after start of implementation
Secondary outcomes (4)
Change in Patient AIRQ Score From Baseline to Follow-up Visits: Mean and Standard Deviation at Each Visit
AIRQ scores range from 0 to 10, where lower scores indicate more well-controlled asthma
The AIRQ was used for the initial study visit, and a follow-up AIRQ that employs the same 10 questions as the AIRQ but for the 3 risk questions where exacerbation history covers a 3 month look-back period instead of a 12 month look-back period was used for follow-up visits.
Measured: Mean (SD) time to follow-up was 3.3 (SD = 1.4) months
Change in Patient AIRQ Score From Baseline to Follow-up Visits: Mean Difference and Confidence Interval
AIRQ scores range from 0 to 10, where lower scores indicate more well-controlled asthma
The AIRQ was used for the initial study visit, and a follow-up AIRQ that employs the same 10 questions as the AIRQ but for the 3 risk questions where exacerbation history covers a 3 month look-back period instead of a 12 month look-back period was used for follow-up visits.
Measured: Mean (SD) time to follow-up was 3.3 (SD = 1.4) months
Change in Patient AIRQ Control Level From Baseline to Follow-up Visit
AIRQ Control level can be categorized as "well controlled", "not-well controlled" or "very poorly controlled"
The AIRQ was used for the initial study visit, and a follow-up AIRQ that employs the same 10 questions as the AIRQ but for the 3 risk questions where exacerbation history covers a 3 month look-back period instead of a 12 month look-back period was used for follow-up visits.
Measured: Mean (SD) time to follow-up was 3.3 (SD = 1.4) months
Percentage of Endorsement of Responses for Each of the 8 Categorical Items on the ACE Questionnaire
The ACE questionnaire includes 8 items each with Likert scale responses (strongly agree, agree, disagree, strongly disagree). Participants completed this measure via a patient web survey.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start20 Apr 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
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 (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 857 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891978
- Sponsor's protocol ID
- D2287L00028
- Status last verified
- Jun 2025
- First submitted
- 29 Mar 2021
- Last updated
- 8 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Murphy KR, Chipps B, Beuther DA, Wise RA, McCann W, Gilbert I, Eudicone JM, Gandhi HN, Harding G, Coyne KS, Zeiger RS; US PRECISION Advisory Board. Development of the Asthma Impairment and Risk Questionnaire (AIRQ): A Composite Control Measure. J Allergy Clin Immunol Pract. 2020 Jul-Aug;8(7):2263-2274.e5. doi: 10.1016/j.jaip.2020.02.042. Epub 2020 May 6.
PubMed 32387166
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the US PRECISION AIRQ, Asthma Checklist, and Educational Resources (PRECISION Program) Into Clinical Practice Using Telehealth and In-Person Platforms
- ClinicalTrials.gov ID
- NCT04891978
- Acronym / sponsor ID
- D2287L00028
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 857 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Posted 8 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this community program intervention study is to assess the process and potential benefits of integrating the AIRQ®, Asthma Checklist, and educational resources (PRECISION program) into clinical practice using either in-person or telehealth visits.
The secondary objectives are to assess asthma patients' clinic visit experiences when the AIRQ, the Asthma Checklist, and educational resources (PRECISION program) are utilized as part of a telehealth or in-person visit with their HCP, and to explore change in AIRQ scores from the initial visit to follow-up visit(s) (when available).
Detailed description
This community program intervention study will examine the process of integrating the AIRQ, Asthma Checklist, and educational resources (PRECISION program) into clinical practice using either in-person or telehealth visits. Providers use of patients' responses to the AIRQ, Asthma Checklist, and educational resources to guide treatment and asthma work-up and management also will be examined. The study duration is 12-months, with study enrollment lasting nine (9) months for each site (implementation stage), and an additional three (3) months of follow-up to assess the sustainability of using the PRECISION program in clinical practice (sustainability stage). The nine-month implementation stage will allow for the recruitment of approximately 50 patients at each site (maximum of 75 patients at each site) for an initial study visit, plus the potential for follow-up visit(s). The three-month sustainability stage will allow for sites to continue to implement the PRECISION program in their clinical practice and for sites to describe any continued benefits of using the PRECISION program at their site.
Approximately fifteen (15) to twenty (20) clinical sites will be recruited to participate in this study, categorized into the following four practice clusters: (1) primary care site (e.g., private practice, FQHC; (2) specialty care site (pulmonary, asthma/immunology); and (3) novel sites (e.g., pharmacy, nurse practitioners, nurse educators, prescribers and Non-prescribers, telehealth component of Allergy and Asthma Network. While all sites will be able to conduct both in-person and telehealth visits, sites will aim to conduct a minimum of approximately 25% of their initial patient visit using a telehealth platform. Both platforms (in-person and telehealth) can be used for the follow-up visit(s) for all practice types.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIRQ, Asthma Checklist, and PRECISION Program | Experimental | Behavioral: AIRQ, Behavioral: Asthma Checklist, Behavioral: PRECISION Program (Educational Resources)All participants in the trial will be given the behavioral interventions which include the AIRQ tool, the Asthma Checklist tool, and the PRECISION program educational resources. |
Who may qualify
- Ages
- 13 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- >= 13 years of age at the time of enrollment
- Diagnosis of HCP-confirmed asthma
- Able to read, understand and speak English or Spanish sufficiently self-complete or be administered the AIRQ via telephone, desktop, or mobile device (e.g., smartphone, iPad)
- Provide consent (adults/parents/guardians) and assent (age 13-17 years) to participate in the study.
Key exclusion criteria (2 listed)
- Current diagnosis of active COPD or any lower respiratory diagnosis other than asthma
- Has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, or insufficient knowledge of the English or Spanish language that, in the opinion of the investigator, would interfere with his or her ability to agree to participate and/or complete the AIRQ or other study questionnaires
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 |
|---|---|---|
| AIRQA validated tool designed to identify patients who may be at risk for adverse outcomes from uncontrolled asthma. | Behavioural | AIRQ, Asthma Checklist, and PRECISION Program |
| Asthma ChecklistA validated, 3-page tool, based on GINA and NAEPP guidelines to assist providers with recognition, evaluation, and optimization of all patients with asthma. In this study, healthcare providers will be required to complete the assess component (page 1) of the Asthma Checklist . | Behavioural | AIRQ, Asthma Checklist, and PRECISION Program |
| PRECISION Program (Educational Resources)Educational resources accessible to all providers in the study. There are provider-facing and patient-facing educational materials that can be accessed during the patient visit or as resources for before/after visits. Resources can be downloaded and sent to patients per the discretion of providers. | Behavioural | AIRQ, Asthma Checklist, and PRECISION Program |
Primary outcome
Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Overall Ease of Implementing AIRQ Into Clinical Practice.
Time frame: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
The post-study HCP survey includes questions regarding the implementation of the PRECISION program (e.g., how would you rate the overall ease of implementing the AIRQ into your clinical practice using the telehealth platform?)
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to How Much the AIRQ Helped Manage Patients
Time frame: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., Did AIRQ help you manage your patients?)
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Whether the AIRQ Helped Identify Patients at Risk for Adverse Asthma Health Outcomes
Time frame: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., Did AIRQ help you identify patients who were at risk for adverse health outcomes from their asthma that you would have otherwise missed?)
Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Most and Least Helpful Parts of AIRQ
Time frame: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., What did you find most useful about AIRQ?)
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Frequency of Referring to a Specialist or Practice Type Different Than Their Own While Using the AIRQ
Time frame: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., While using AIRQ how often did you refer to a specialist or practice type different than your own?)
Percentage Endorsement of Responses by Site HCPs for the Categorical Item on the Post-study Survey Relating to Components of Care Improved by AIRQ
Time frame: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., Did AIRQ improve any of the following?)
Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Importance of Using Different Components of the PRECISION Program
Time frame: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
The post-study HCP survey includes questions regarding the implementation of the PRECISION program at the site (e.g., How important was it for you to use the Assess component of the Asthma Checklist (page 1) with the AIRQ?).
Average Number of Patients Treated Using the PRECISION Program at Each Site as Reported by Site HCPs by Site Type
Time frame: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).
The post-study HCP survey asks sites to report the number of patients treated using the PRECISION program at their site. One HCP per site reported on the number of patients treated using the PRECISION program at their site. The mean presented is the number of patients at each site as reported by site HCPs divided by the number of sites.
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Primary Care Sites
Time frame: Post-study survey was completed between 32.9 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
On the post-study survey, one HCP per site (site PI) was asked to describe the features of the PRECISION program they thought were the most useful and could be improved when implemented at their site
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Specialty Care Sites
Time frame: Post-study survey was completed between 22.1 weeks and 50.4 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
On the post-study survey, one HCP per site (site PI) was asked to describe the features of the PRECISION program they thought were most useful and could be improved when implemented at their site
Descriptive Free-text Site HCP Responses to Open-ended Question on Post-study Survey on Features of PRECISION Program: Novel Care Site
Time frame: Post-study survey was completed 5 weeks after last patient end of follow-up; end of follow up was 6 weeks from last patient enrolled at site.
On the post-study survey, one HCP per site (site PI) was asked to describe the features of the PRECISION program they thought were most useful and could be improved when implemented at their site
Descriptive Free-text Clinician Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Primary Care Sites
Time frame: Post-study clinician interviews were completed between -2 weeks (interviews completed a little sooner than end of follow-up) and 52.4 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Site clinicians were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Primary Care Sites
Time frame: Post-study key site staff interviews were completed between -2 weeks (interviews completed a little sooner than end of follow-up) and 43 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Key site staff were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Descriptive Free-text Clinician Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Specialty Care Sites
Time frame: Post-study clinician interviews were completed between -6.3 weeks (interviews completed a little sooner than end of follow-up) and 23 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Site clinicians were asked to respond to several open-ended interview questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Specialty Care Sites
Time frame: Post-study site staff interviews were completed between -6.3 weeks (interviews completed a little sooner than end of follow-up) and 4.7 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site.
Key site staff were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Descriptive Free-text HCP Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Novel Site
Time frame: Post-study HCP interviews were completed 5 weeks after last patient end of follow-up; end of follow up was 6 weeks from last patient enrolled at site.
Site HCPs were asked to respond to several open-ended interview questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Descriptive Free-text Key Site Staff Responses to the Qualitative Interview Questions on Implementation and Features of the Asthma Precision Program: Novel Site
Time frame: Post-study key site staff interviews were completed 5 weeks after last patient end of follow-up; end of follow up was 6 weeks from last patient enrolled at site.
Key site staff were asked to respond to several open-ended questions regarding background information about the site, the implementation process at their site, use of the Asthma Checklist and educational resources, and feedback on the entire program.
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Primary Care Sites (Month 1)
Time frame: Month 1 after start of implementation
At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Primary Care Sites (Month 2)
Time frame: Month 2 after start of implementation
At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Specialty Care Sites (Month 1)
Time frame: Month 1 after start of implementation
At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)
Descriptive Free-text Site Staff Responses to the Implementation Touchpoint Questions: Novel Care Site (Month 2)
Time frame: Month 2 after start of implementation
At each touchpoint, site staff were asked to respond to questions about the implementation of the PRECISION program (e.g., what aspects of the study implementation are going well for your site?)
4 secondary outcomes
Change in Patient AIRQ Score From Baseline to Follow-up Visits: Mean and Standard Deviation at Each Visit
Time frame: Mean (SD) time to follow-up was 3.3 (SD = 1.4) months
Change in Patient AIRQ Score From Baseline to Follow-up Visits: Mean Difference and Confidence Interval
Time frame: Mean (SD) time to follow-up was 3.3 (SD = 1.4) months
Change in Patient AIRQ Control Level From Baseline to Follow-up Visit
Time frame: Mean (SD) time to follow-up was 3.3 (SD = 1.4) months
Percentage of Endorsement of Responses for Each of the 8 Categorical Items on the ACE Questionnaire
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32387166Murphy KR, Chipps B, Beuther DA, Wise RA, McCann W, Gilbert I, Eudicone JM, Gandhi HN, Harding G, Coyne KS, Zeiger RS; US PRECISION Advisory Board. Development of the Asthma Impairment and Risk Questionnaire (AIRQ): A Composite Control Measure. J Allergy Clin Immunol Pract. 2020 Jul-Aug;8(7):2263-2274.e5. doi: 10.1016/j.jaip.2020.02.042. Epub 2020 May 6.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Asthma
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIRQ, Asthma Checklist and PRECISION Program (Educational Resources) in people with Asthma, run by AstraZeneca at 13 sites 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 4 inclusion and 2 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 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 8 Jul 2025). 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?
Percentage Endorsement of Responses by Site HCPs for Each Categorical Item on the Post-study Survey Relating to Overall Ease of Implementing AIRQ Into Clinical Practice. (time frame: Post-study survey was completed between 5 weeks and 50.6 weeks of last patient end of follow-up across sites; end of follow up was 36 weeks from last patient enrolled at site (or 6 weeks for the novel care site).). The study lists 21 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 NCT04891978, which also lists 1 linked publication.
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 8 Jul 2025.