Pediatric AsthmaPEAKmAAPNCT03842033
Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients
A study testing PEAKmAAP and PEAKmAAP-DS in people with Pediatric Asthma, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Asthma
- What is being tested?
- PEAKmAAP and PEAKmAAP-DS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2019to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age ≥12 and <21 years
- Persistent asthma according to national guidelines criteria
- Asthma Control Test (ACT) score ≤19
- Prescribed a preventive (controller) asthma medication in the past 6 months
- Access to a smartphone compatible with the PEAKmAAP and NutriMap
- Access to the internet
- Able to read and speak English
Who cannot join
- Significant underlying respiratory disease other than asthma, such as cystic fibrosis
- Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the adolescent's ability to self-monitor asthma
- Current smoker
- Participation in the investigator's or other asthma clinical trials in the previous 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
About this study
The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan.
Read the detailed description
The proposed project aligns with our prior work targeting high-risk pediatric asthma populations in non-inner city environments by targeting adolescents at risk for future exacerbations from the Patient-Centered Medical Home (PCMH) at Arkansas Children's Hospital (ACH).
We propose to conduct a 3-arm randomized, controlled trial with 372 adolescents with uncontrolled asthma to test the effectiveness of mAAP. mAAP provides real-time, personalized feedback, asthma education, and data logging/tracking capabilities.
- Conditions
- Pediatric Asthma
- Being tested
- PEAKmAAP, PEAKmAAP-DS, NutriMap Usual Care
- Keywords
- Asthma Action Plan, Smartphone App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAKmAAPBehavioural
The PEAKmAAP group will use a mobile "app" that will help manage asthma.
PEAKmAAP-DSBehavioural
This group will use the mobile app to help manage asthma. the primary care provider will receive monthly reports to help him/her know how the participants asthma symptoms are over time.
NutriMap Usual CareBehavioural
This group will use a non-asthma related app daily to record their daily intake of fruits and vegetables.
| Study group | Role | What they receive |
|---|---|---|
| PEAKmAAP | Other | The Pulmonary Education and Asthma Knowledge mobile asthma action plan (PEAKmAAP) group will use a mobile "app" that will help manage asthma. Participants will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. mAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. Receives: Behavioral: PEAKmAAP |
| PEAKmAAP-Data Sharing (DS) | Other | PEAKmAAP with Data Sharing (PEAKmAAP-DS) group will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. PEAKmAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. The primary care provided (PCP) will receive monthly reports to help them know how the participant's asthma symptoms are over time. Receives: Behavioral: PEAKmAAP-DS |
| Nutrition Map (NutriMap) Usual Care | Other | Participants in this arm will use a smartphone application that sends daily non-asthma-related reminder for attention control. Participants will be asked to log their daily fruits and vegetables eaten. Participants will answer survey questions about their asthma and symptoms management. Receives: Behavioral: NutriMap Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Asthma Control Test (ACT) Score
The primary outcome measure will be the change from ACT score ≤19 (uncontrolled asthma) to ACT >19 (controlled asthma) at 3 months.
ACT is a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indication well controlled asthma. A score of less than or equal 19 is considered poorly controlled asthma.
Measured: 3 months
Secondary outcomes (6)
Mediators of Asthma Control
Medication adherence and asthma self-efficacy. Pharmacy profiles will be accessed to determine medication adherence. We plan to administer the Pediatric Quality of Life (PedsQOL). We plan to evaluate if participants are more likely to receive step up therapy per the national asthma guidelines.
Measured: 12 months
Healthcare Utilization
We plan to utilize the PedsQOL instrument to measure participant quality of life. The PedQOL is a modular approach to measuring health related quality of life in children and adolescents with acute chronic health conditions. The instrument has a disease specific module for asthma. The instrument access four scales: physical functioning, emotional functioning, social functioning and school functioning.
Measured: 12 months
Change in Asthma Control Test (ACT) Score to Access Secondary Outcomes
ACT a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indicating well controlled asthma. A score of less than or equal 19 is considered poorly controlled asthma. We plan to prospectively assess clinical outcomes including ACT score, Composite Asthma Severity Index (CASI) score, acute healthcare utilization, medication use, and lung function. ACT scores may improve but remain ≤19 for participants with very poorly controlled asthma, we will assess for change in ACT score that is considered to be clinically important (as indicated by ≥3 point increase).The ACT score will be assessed via mobile survey to measure for sustained improvement throughout the study. We hypothesize that PCP data sharing will facilitate asthma control by alerting the PCP when asthma is worsening or failing to improve. The impact of PCP data sharing on ACT score will be measured to assess whether data sharing has added benefit to PEAKmAAP alone.
Measured: 12 months
Composite Asthma Severity Index (CASI) score
The CASI quantify disease severity by looking at impairment risk and the amount of medication needed to maintain control. The CASI includes the major domains of asthma namely, impairment, as measured by day and night symptoms, along with albuterol use; and risk measured by forced expiratory volume in one second (FEV1) percent predicted and past asthma exacerbations, both of which are important predictors of future exacerbations.
Measured: 12 months
Asthma Control Classification
Asthma guidelines categorize asthma control for individuals ≥12 years into 3 categories: well-controlled (WC), not well-controlled (NWC), or very poorly controlled (VPC). Asthma control is defined by the degree to which asthma manifestations are minimized by therapeutic intervention. Components of asthma control include measures of daytime symptoms, nighttime awakenings, activity limits, rescue medication use, and exacerbations requiring oral systemic corticosteroids. An assessment of asthma control will be made during the eligibility screening, at the in-person, structured interviews at baseline, 3 months and 12 months as well as via mobile survey at 6 and 9 months for all participants.
Measured: 12 months
Lung Function and Airway Inflammation
Spirometry is the test most used for the assessment of the risk for adverse events and impairment in asthma. Forced expiratory volume in the first second (FEV1) expressed as percent predictive of reference population value or as a proportion of the forced vital capacity (FEV1/FVC) will be assessed. FeNO is a quantitative, non-invasive measure of airway inflammation that predicts responsiveness and adherence to ICS. We will measure lung function and FeNO at baseline, 3 months, and 12 months for all participants.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start4 Mar 2019
- Primary completion1 Jun 2024
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pediatric AsthmaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct a randomized, controlled trial of 372 adolescents with uncontrolled mild-severe persistent asthma to examine the effectiveness of a personalized, interactive PEAKmAAP application with and without PCP data sharing in reducing asthma morbidity. The trial includes 3 groups: 1) a group utilizing the PEAKmAAP alone, 2) a group utilizing the PEAKmAAP with PCP data sharing (PEAKmAAP-DS), and 3) a usual care NutriMapgroup utilizing an application with daily non-asthma related reminders for attention control.
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Tamara T. Perry, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842033
- Sponsor's protocol ID
- 206110
- Other IDs
- 1R01NR015988-01A1
- Acronym
- PEAKmAAP
- Status last verified
- May 2026
- First submitted
- 15 May 2017
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
MacDonald P. Understanding and treating asthma in adolescents. Paediatr Nurs. 2003 Feb;15(1):34-6. No abstract available.
PubMed 12655953Naimi DR, Freedman TG, Ginsburg KR, Bogen D, Rand CS, Apter AJ. Adolescents and asthma: why bother with our meds? J Allergy Clin Immunol. 2009 Jun;123(6):1335-41. doi: 10.1016/j.jaci.2009.02.022. Epub 2009 Apr 22.
PubMed 19395075Braun-Fahrlander C, Gassner M, Grize L, Minder CE, Varonier HS, Vuille JC, Wuthrich B, Sennhauser FH. Comparison of responses to an asthma symptom questionnaire (ISAAC core questions) completed by adolescents and their parents. SCARPOL-Team. Swiss Study on Childhood Allergy and Respiratory Symptoms with respect to Air Pollution. Pediatr Pulmonol. 1998 Mar;25(3):159-66. doi: 10.1002/(sici)1099-0496(199803)25:33.0.co;2-h.
PubMed 9556007Venn A, Lewis S, Cooper M, Hill J, Britton J. Questionnaire study of effect of sex and age on the prevalence of wheeze and asthma in adolescence. BMJ. 1998 Jun 27;316(7149):1945-6. doi: 10.1136/bmj.316.7149.1945. No abstract available.
PubMed 9641931Forero R, Bauman A, Young L, Larkin P. Asthma prevalence and management in Australian adolescents: results from three community surveys. J Adolesc Health. 1992 Dec;13(8):707-12. doi: 10.1016/1054-139x(92)90068-m.
PubMed 1290773Kyngas HA. Compliance of adolescents with asthma. Nurs Health Sci. 1999 Sep;1(3):195-202. doi: 10.1046/j.1442-2018.1999.00025.x.
PubMed 10894643Raherison C, Tunon-de-Lara JM, Vernejoux JM, Taytard A. Practical evaluation of asthma exacerbation self-management in children and adolescents. Respir Med. 2000 Nov;94(11):1047-52. doi: 10.1053/rmed.2000.0888.
PubMed 11127490Buston KM, Wood SF. Non-compliance amongst adolescents with asthma: listening to what they tell us about self-management. Fam Pract. 2000 Apr;17(2):134-8. doi: 10.1093/fampra/17.2.134.
PubMed 10758075Blaakman SW, Cohen A, Fagnano M, Halterman JS. Asthma medication adherence among urban teens: a qualitative analysis of barriers, facilitators and experiences with school-based care. J Asthma. 2014 Jun;51(5):522-9. doi: 10.3109/02770903.2014.885041. Epub 2014 Feb 7.
PubMed 24494626McQuaid EL, Kopel SJ, Klein RB, Fritz GK. Medication adherence in pediatric asthma: reasoning, responsibility, and behavior. J Pediatr Psychol. 2003 Jul-Aug;28(5):323-33. doi: 10.1093/jpepsy/jsg022.
PubMed 12808009Moorman JE, Rudd RA, Johnson CA, King M, Minor P, Bailey C, Scalia MR, Akinbami LJ; Centers for Disease Control and Prevention (CDC). National surveillance for asthma--United States, 1980-2004. MMWR Surveill Summ. 2007 Oct 19;56(8):1-54.
PubMed 17947969Perry TT, Turner JH, Berlinski A, Simmons LA, Brown RH, Neal K, Marshall SA, He X, Chung S, Brown A, Spencer Rd HJ, Bian J. Comparing a Guideline-Based Mobile Health Intervention Versus Usual Care for High-Risk Adolescents With Asthma: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 25;14:e69903. doi: 10.2196/69903.
PubMed 40712131
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients
- ClinicalTrials.gov ID
- NCT03842033
- Acronym / sponsor ID
- PEAKmAAP / 206110
- Conditions
- Pediatric Asthma
- Keywords
- Asthma Action Plan, Smartphone App
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan.
Detailed description
The proposed project aligns with our prior work targeting high-risk pediatric asthma populations in non-inner city environments by targeting adolescents at risk for future exacerbations from the Patient-Centered Medical Home (PCMH) at Arkansas Children's Hospital (ACH).
We propose to conduct a 3-arm randomized, controlled trial with 372 adolescents with uncontrolled asthma to test the effectiveness of mAAP. mAAP provides real-time, personalized feedback, asthma education, and data logging/tracking capabilities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- We will conduct a randomized, controlled trial of 372 adolescents with uncontrolled mild-severe persistent asthma to examine the effectiveness of a personalized, interactive PEAKmAAP application with and without PCP data sharing in reducing asthma morbidity. The trial includes 3 groups: 1) a group utilizing the PEAKmAAP alone, 2) a group utilizing the PEAKmAAP with PCP data sharing (PEAKmAAP-DS), and 3) a usual care NutriMapgroup utilizing an application with daily non-asthma related reminders for attention control.
| Arm | Type | Receives |
|---|---|---|
| PEAKmAAP | Other | Behavioral: PEAKmAAPThe Pulmonary Education and Asthma Knowledge mobile asthma action plan (PEAKmAAP) group will use a mobile "app" that will help manage asthma. Participants will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. mAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. |
| PEAKmAAP-Data Sharing (DS) | Other | Behavioral: PEAKmAAP-DSPEAKmAAP with Data Sharing (PEAKmAAP-DS) group will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. PEAKmAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. The primary care provided (PCP) will receive monthly reports to help them know how the participant's asthma symptoms are over time. |
| Nutrition Map (NutriMap) Usual Care | Other | Behavioral: NutriMap Usual CareParticipants in this arm will use a smartphone application that sends daily non-asthma-related reminder for attention control. Participants will be asked to log their daily fruits and vegetables eaten. Participants will answer survey questions about their asthma and symptoms management. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age ≥12 and <21 years
- Persistent asthma according to national guidelines criteria
- Asthma Control Test (ACT) score ≤19
- Prescribed a preventive (controller) asthma medication in the past 6 months
- Access to a smartphone compatible with the PEAKmAAP and NutriMap
Key exclusion criteria (4 listed)
- Significant underlying respiratory disease other than asthma, such as cystic fibrosis
- Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the adolescent's ability to self-monitor asthma
- Current smoker
- Participation in the investigator's or other asthma clinical trials in the previous 6 months
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 |
|---|---|---|
| PEAKmAAPThe PEAKmAAP group will use a mobile "app" that will help manage asthma. | Behavioural | PEAKmAAP |
| PEAKmAAP-DSThis group will use the mobile app to help manage asthma. the primary care provider will receive monthly reports to help him/her know how the participants asthma symptoms are over time. | Behavioural | PEAKmAAP-Data Sharing (DS) |
| NutriMap Usual CareThis group will use a non-asthma related app daily to record their daily intake of fruits and vegetables. | Behavioural | Nutrition Map (NutriMap) Usual Care |
Primary outcome
Change in Asthma Control Test (ACT) Score
Time frame: 3 months
The primary outcome measure will be the change from ACT score ≤19 (uncontrolled asthma) to ACT >19 (controlled asthma) at 3 months. ACT is a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indication well controlled asthma. A score of less than or equal 19 is considered poorly controlled asthma.
6 secondary outcomes
Mediators of Asthma Control
Time frame: 12 months
Healthcare Utilization
Time frame: 12 months
Change in Asthma Control Test (ACT) Score to Access Secondary Outcomes
Time frame: 12 months
Composite Asthma Severity Index (CASI) score
Time frame: 12 months
Asthma Control Classification
Time frame: 12 months
Lung Function and Airway Inflammation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 12655953MacDonald P. Understanding and treating asthma in adolescents. Paediatr Nurs. 2003 Feb;15(1):34-6. No abstract available.
- Background: PubMed 19395075Naimi DR, Freedman TG, Ginsburg KR, Bogen D, Rand CS, Apter AJ. Adolescents and asthma: why bother with our meds? J Allergy Clin Immunol. 2009 Jun;123(6):1335-41. doi: 10.1016/j.jaci.2009.02.022. Epub 2009 Apr 22.
- Background: PubMed 9556007Braun-Fahrlander C, Gassner M, Grize L, Minder CE, Varonier HS, Vuille JC, Wuthrich B, Sennhauser FH. Comparison of responses to an asthma symptom questionnaire (ISAAC core questions) completed by adolescents and their parents. SCARPOL-Team. Swiss Study on Childhood Allergy and Respiratory Symptoms with respect to Air Pollution. Pediatr Pulmonol. 1998 Mar;25(3):159-66. doi: 10.1002/(sici)1099-0496(199803)25:33.0.co;2-h.
- Background: PubMed 9641931Venn A, Lewis S, Cooper M, Hill J, Britton J. Questionnaire study of effect of sex and age on the prevalence of wheeze and asthma in adolescence. BMJ. 1998 Jun 27;316(7149):1945-6. doi: 10.1136/bmj.316.7149.1945. No abstract available.
- Background: PubMed 1290773Forero R, Bauman A, Young L, Larkin P. Asthma prevalence and management in Australian adolescents: results from three community surveys. J Adolesc Health. 1992 Dec;13(8):707-12. doi: 10.1016/1054-139x(92)90068-m.
- Background: PubMed 10894643Kyngas HA. Compliance of adolescents with asthma. Nurs Health Sci. 1999 Sep;1(3):195-202. doi: 10.1046/j.1442-2018.1999.00025.x.
- Background: PubMed 11127490Raherison C, Tunon-de-Lara JM, Vernejoux JM, Taytard A. Practical evaluation of asthma exacerbation self-management in children and adolescents. Respir Med. 2000 Nov;94(11):1047-52. doi: 10.1053/rmed.2000.0888.
- Background: PubMed 10758075Buston KM, Wood SF. Non-compliance amongst adolescents with asthma: listening to what they tell us about self-management. Fam Pract. 2000 Apr;17(2):134-8. doi: 10.1093/fampra/17.2.134.
- Background: PubMed 24494626Blaakman SW, Cohen A, Fagnano M, Halterman JS. Asthma medication adherence among urban teens: a qualitative analysis of barriers, facilitators and experiences with school-based care. J Asthma. 2014 Jun;51(5):522-9. doi: 10.3109/02770903.2014.885041. Epub 2014 Feb 7.
- Background: PubMed 12808009McQuaid EL, Kopel SJ, Klein RB, Fritz GK. Medication adherence in pediatric asthma: reasoning, responsibility, and behavior. J Pediatr Psychol. 2003 Jul-Aug;28(5):323-33. doi: 10.1093/jpepsy/jsg022.
- Background: PubMed 17947969Moorman JE, Rudd RA, Johnson CA, King M, Minor P, Bailey C, Scalia MR, Akinbami LJ; Centers for Disease Control and Prevention (CDC). National surveillance for asthma--United States, 1980-2004. MMWR Surveill Summ. 2007 Oct 19;56(8):1-54.
- Derived from this study: PubMed 40712131Perry TT, Turner JH, Berlinski A, Simmons LA, Brown RH, Neal K, Marshall SA, He X, Chung S, Brown A, Spencer Rd HJ, Bian J. Comparing a Guideline-Based Mobile Health Intervention Versus Usual Care for High-Risk Adolescents With Asthma: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 25;14:e69903. doi: 10.2196/69903.
- Individual participant dataSharing planned: No
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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.
Tamara T. Perry, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEAKmAAP and PEAKmAAP-DS in people with Pediatric Asthma, run by Arkansas Children's Hospital Research Institute 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Asthma Control Test (ACT) Score (time frame: 3 months). 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 NCT03842033, which also lists 12 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 8 May 2026.