Asthma in ChildrenPhase 1/2NCT05689983
Symptom-driven ICS/LABA Therapy for Adolescent Patients With Asthma Non-adherent to Daily Maintenance Inhalers
A Phase 1/2 study testing Maintenance ICS and Symptom Driven SABA and Symptom-driven budesonide/formoterol combination in people with Asthma in Children and Nonadherence, Medication, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Inhaler nonadherence is a common problem that has been estimated to account for approximately 60% of all asthma-related hospitalizations. Unfortunately, prior interventions to improve inhaler nonadherence have shown a lack of long-term success. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma in Children, Nonadherence, Medication
- What is being tested?
- Maintenance ICS and Symptom Driven SABA and Symptom-driven budesonide/formoterol combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 25 Sep 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Able to understand and provide informed consent.
- Age 18-75 at the time of study enrollment.
- Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICS treatment and as needed SABA for at least 6 months prior to enrollment.
- Suboptimal adherence to prescribed maintenance ICS therapy defined as missing at least expected 2 ICS refills in the prior 6 months based on examination of pharmacy records or a Medication Adherence Report Scale for Asthma (MARS-A) score <4.5.
- An Asthma Control Test (ACT) score at enrollment greater than or equal to 12 but less than or equal to 20 indicating partially controlled or moderately uncontrolled asthma.
- iPhone or Android smartphone with an active data plan and willingness to use the Adherium device.
Who cannot join
- Relevant comorbid pulmonary diseases including, but not limited to a diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or alpha 1 anti-trypsin deficiency.
- Current use of a biologic medication or investigational treatment for asthma.
- History of asthma requiring ICU admission in the last year.
- Unwillingness to use or pay for an inhaler that is compatible with the Adherium sensor (fluticasone propionate or budesonide/formoterol). Of note, fluticasone and budesonide/formoterol are formulary tier 1-2 for Missouri Medicaid and most commercial insurances and are believed to be equally or less expensive as alternative inhalers for most patients.
- Any clinically significant abnormalities on physical exam, laboratory testing, or baseline diagnostic testing that the study team believes will make the study unsafe.
- Patients who do not complete at least 70% of the twice-daily texts during the two weeks after screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
About this study
Inhaler nonadherence is a common problem that has been estimated to account for approximately 60% of all asthma-related hospitalizations. Unfortunately, prior interventions to improve inhaler nonadherence have shown a lack of long-term success. This study proposes to assess the problem of non-adherence using a D\&I research lens while testing a new inhaler approach to potentially ameliorate the detrimental consequences of maintenance inhaler nonadherence.
Read the detailed description
While inhaled corticosteroids (ICS) are considered the essential foundation of most asthma therapy, ICS inhaler non-adherence is a notoriously common problem and a significant cause of asthma-related morbidity. Partially acknowledging the problem of non-adherence, international organizations recently made paradigm-shifting recommendations that all patients with mild or mild-to-moderate persistent asthma be considered for symptom-driven ICS-containing inhalers rather than relying on adherence to traditional maintenance ICS inhalers and symptom-driven beta-agonists. With this novel approach, asthma patients are at least exposed to the important anti-inflammatory effects of ICS-containing inhalers when their inhaler is deployed due to symptoms. The proposed study aims to (Aim 1) undertake a pragmatic pilot randomized-controlled trial to evaluate if an inhaler strategy that utilizes symptom-driven ICS inhalers is particularly accepted and beneficial in maintenance ICS inhaler non-adherent adolescent asthma patients, and (Aim 2) use a D\&I science conceptual framework to better understand patients' and providers' views of inhaler non-adherence. This study will use an electronic sensor to monitor inhaler adherence and include semi-structured interviews using the Consolidated Framework for Implementation Research (CFIR).
- Conditions
- Asthma in Children, Nonadherence, Medication
- Being tested
- Maintenance ICS and Symptom Driven SABA, Symptom-driven budesonide/formoterol combination
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance ICS and Symptom Driven SABADrug
In this intervention, patients will be assigned to a standard therapy with a maintenance inhaled corticosteroid (Flovent) and an as needed short-acting beta-agonist and their adherence to this regimen will be assessed and compared to patients taking a regimen with an as needed inhaled corticosteroid and long-acting beta-agonist.
Symptom-driven budesonide/formoterol combinationDrug
In this intervention, patients will be assigned to a symptom-driven budesonide/formoterol combination therapy (Symbicort) and their adherence to this regimen will be assessed and compared to patients taking a standard therapy with a maintenance inhaled corticosteroid and as needed short-acting beta-agonist.
| Study group | Role | What they receive |
|---|---|---|
| As needed inhaled corticosteroid and long-acting beta-agonist | Active comparator | Symptom-driven ICS/LABA treatment strategy Receives: Drug: Symptom-driven budesonide/formoterol combination |
| Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonist | Placebo comparator | Continue maintenance ICS and SABA therapy Receives: Drug: Maintenance ICS and Symptom Driven SABA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to inhaler strategy delineated using an electronic inhaler sensor
The primary outcome will be adherence with an inhaler management strategy delineated using the Adherium inhaler sensor and smartphone application as compared between groups. Adherence to the treatment strategy for the maintenance ICS inhaler group will be calculated as the proportion of maintenance ICS actuations per prescription recommendation. Adherence for the symptom-based ICS treatment strategy will be calculated as the proportion of ICS/LABA actuations per recommendation based on self-report of symptoms (definition: ICS/LABA inhaler actuation during a day or night period divided by a period wherein a patient identified symptoms as >1 on REDCap-delivered smartphone questionnaire).
Measured: 24 weeks
Secondary outcomes (11)
Number of asthma exacerbations
Frequency of study-defined asthma exacerbations between groups (adjusted for time on treatment). Asthma exacerbations will be defined as an urgent medical visit for asthma symptoms, prescription of oral corticosteroids for asthma symptoms, or high use of a rescue inhaler (>16 actuations of SABA or >8 actuations of ICS/LABA within 24 hours on two consecutive days as assessed via the Adherium device).
Measured: 24 weeks
Time to asthma exacerbation
Time to first exacerbation between groups. Asthma exacerbations will be defined as an urgent medical visit for asthma symptoms, prescription of oral corticosteroids for asthma symptoms, or high use of a rescue inhaler (>16 actuations of SABA or >8 actuations of ICS/LABA within 24 hours on two consecutive days as assessed via the Adherium device)
Measured: 24 weeks
ICS exposure
Converted cumulative dose of ICS between groups.
Measured: 24 weeks
Adverse and serious adverse events
Occurrence of any severe and non-severe adverse events between groups.
Measured: 24 weeks
Change in Asthma Control Questionnaire (ACQ)
Change in Asthma Control Questionnaire (ACQ) from baseline to the final study visit. This is measured using the Asthma Control Questionnaire (ACQ) which is scaled from a minimum of 0 to a maximum of 6 for each question with higher scores indicating greater asthma control.
Measured: 24 weeks
Change in asthma control test (ACT)
Change in Asthma Control Test (ACT) from baseline to the final study visit. This is measured using the Asthma Control Test (ACT) is scaled on a 5 point Likert scale from a minimum of 1 to a maximum of 5 for each question with higher scores indicating greater asthma control.
Measured: 24 weeks
Change in Asthma Quality of Life Questionnaire (AQLQ)
Change in Asthma Quality of Life Questionnaire (AQLQ) from baseline to the final study visit. This is measured using the Asthma Quality of Life Questionnaire (AQLQ) which is scaled on a 7 point Likert scale from a minimum of 1 to a maximum of 7 for each question with higher scores indicating no impairment in activities due to asthma.
Measured: 24 weeks
Change in Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire
Change in Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire from baseline to the final study visit. This is measured using the Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire which is scaled on a 5 point Likert scale from a minimum of 1 to a maximum of 5 for each question with higher scores indicating better adherence to medication.
Measured: 24 weeks
Change in IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)
Change in IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM) from baseline to the final study visit. This is measured using the IQVIA Treatment Satisfaction Questionnaire for Medication Version II (TSQM-2) which has 11 questions, 10 of which are scaled on a Likert scale from a minimum of 1 (Extremely Dissatisfied) to a maximum of 7 (Extremely Satisfied) with the exception of one question that asks about the experience of side effects in patients with answer choices of yes or no with higher scores indicating greater patient satisfaction with their medications.
Measured: 24 weeks
Change in The Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ)
Change in The Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ) from baseline to the final study visit. This is measured using the Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ) which contains a series of statements in the domains of knowledge, attitude, and self-efficacy with answer choices of True, Mostly True, Sometimes True and Sometimes False, Mostly False, and False. Higher scores indicated greater knowledge of asthma and asthma management, greater optimism and willingness in self-management of asthma, and greater confidence in the ability to manage and control asthma.
Measured: 24 weeks
Change in Feeling of Satisfaction with Inhaler (FSI-10) questionnaire
Change in Feeling of Satisfaction with Inhaler (FSI-10) questionnaire from baseline to the final study visit. This is measured using the Feeling of Satisfaction with Inhaler questionnaire (FSI-10) which contains 10 questions that are scaled on a 5 point Likert scale with answer options ranging from 1 (hardly at all) to 5 (very) with higher scores indicating greater satisfaction with the inhaler.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Apr 2022
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will occur using a 1:1 ratio with random numbers generated using SAS 9.4
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- James Krings, MD MSc, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689983
- Sponsor's protocol ID
- 202203033
- Other IDs
- KL2TR002346, UL1TR002345
- Status last verified
- Aug 2026
- First submitted
- 9 Jan 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom-driven ICS/LABA Therapy for Adolescent Patients With Asthma Non-adherent to Daily Maintenance Inhalers
- ClinicalTrials.gov ID
- NCT05689983
- Acronym / sponsor ID
- 202203033
- Conditions
- Asthma in Children, Nonadherence, Medication
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 19 Jan 2023 (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.
Inhaler nonadherence is a common problem that has been estimated to account for approximately 60% of all asthma-related hospitalizations. Unfortunately, prior interventions to improve inhaler nonadherence have shown a lack of long-term success. This study proposes to assess the problem of non-adherence using a D\&I research lens while testing a new inhaler approach to potentially ameliorate the detrimental consequences of maintenance inhaler nonadherence.
Detailed description
While inhaled corticosteroids (ICS) are considered the essential foundation of most asthma therapy, ICS inhaler non-adherence is a notoriously common problem and a significant cause of asthma-related morbidity. Partially acknowledging the problem of non-adherence, international organizations recently made paradigm-shifting recommendations that all patients with mild or mild-to-moderate persistent asthma be considered for symptom-driven ICS-containing inhalers rather than relying on adherence to traditional maintenance ICS inhalers and symptom-driven beta-agonists. With this novel approach, asthma patients are at least exposed to the important anti-inflammatory effects of ICS-containing inhalers when their inhaler is deployed due to symptoms. The proposed study aims to (Aim 1) undertake a pragmatic pilot randomized-controlled trial to evaluate if an inhaler strategy that utilizes symptom-driven ICS inhalers is particularly accepted and beneficial in maintenance ICS inhaler non-adherent adolescent asthma patients, and (Aim 2) use a D\&I science conceptual framework to better understand patients' and providers' views of inhaler non-adherence. This study will use an electronic sensor to monitor inhaler adherence and include semi-structured interviews using the Consolidated Framework for Implementation Research (CFIR).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will occur using a 1:1 ratio with random numbers generated using SAS 9.4
| Arm | Type | Receives |
|---|---|---|
| As needed inhaled corticosteroid and long-acting beta-agonist | Active comparator | Drug: Symptom-driven budesonide/formoterol combinationSymptom-driven ICS/LABA treatment strategy |
| Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonist | Placebo comparator | Drug: Maintenance ICS and Symptom Driven SABAContinue maintenance ICS and SABA therapy |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Able to understand and provide informed consent.
- Age 18-75 at the time of study enrollment.
- Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICS treatment and as needed SABA for at least 6 months prior to enrollment.
- Suboptimal adherence to prescribed maintenance ICS therapy defined as missing at least expected 2 ICS refills in the prior 6 months based on examination of pharmacy records or a Medication Adherence Report Scale for Asthma (MARS-A) score <4.5.
- An Asthma Control Test (ACT) score at enrollment greater than or equal to 12 but less than or equal to 20 indicating partially controlled or moderately uncontrolled asthma.
Key exclusion criteria (6 listed)
- Relevant comorbid pulmonary diseases including, but not limited to a diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or alpha 1 anti-trypsin deficiency.
- Current use of a biologic medication or investigational treatment for asthma.
- History of asthma requiring ICU admission in the last year.
- Unwillingness to use or pay for an inhaler that is compatible with the Adherium sensor (fluticasone propionate or budesonide/formoterol). Of note, fluticasone and budesonide/formoterol are formulary tier 1-2 for Missouri Medicaid and most commercial insurances and are believed to be equally or less expensive as alternative inhalers for most patients.
- Any clinically significant abnormalities on physical exam, laboratory testing, or baseline diagnostic testing that the study team believes will make the study unsafe.
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 |
|---|---|---|
| Maintenance ICS and Symptom Driven SABAIn this intervention, patients will be assigned to a standard therapy with a maintenance inhaled corticosteroid (Flovent) and an as needed short-acting beta-agonist and their adherence to this regimen will be assessed and compared to patients taking a regimen with an as needed inhaled corticosteroid and long-acting beta-agonist. | Drug | Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonist |
| Symptom-driven budesonide/formoterol combinationIn this intervention, patients will be assigned to a symptom-driven budesonide/formoterol combination therapy (Symbicort) and their adherence to this regimen will be assessed and compared to patients taking a standard therapy with a maintenance inhaled corticosteroid and as needed short-acting beta-agonist. | Drug | As needed inhaled corticosteroid and long-acting beta-agonist |
Primary outcome
Adherence to inhaler strategy delineated using an electronic inhaler sensor
Time frame: 24 weeks
The primary outcome will be adherence with an inhaler management strategy delineated using the Adherium inhaler sensor and smartphone application as compared between groups. Adherence to the treatment strategy for the maintenance ICS inhaler group will be calculated as the proportion of maintenance ICS actuations per prescription recommendation. Adherence for the symptom-based ICS treatment strategy will be calculated as the proportion of ICS/LABA actuations per recommendation based on self-report of symptoms (definition: ICS/LABA inhaler actuation during a day or night period divided by a period wherein a patient identified symptoms as >1 on REDCap-delivered smartphone questionnaire).
11 secondary outcomes
Number of asthma exacerbations
Time frame: 24 weeks
Time to asthma exacerbation
Time frame: 24 weeks
ICS exposure
Time frame: 24 weeks
Adverse and serious adverse events
Time frame: 24 weeks
Change in Asthma Control Questionnaire (ACQ)
Time frame: 24 weeks
Change in asthma control test (ACT)
Time frame: 24 weeks
Change in Asthma Quality of Life Questionnaire (AQLQ)
Time frame: 24 weeks
Change in Medication Adherence Reporting Scale for Asthma (MARS-A) questionnaire
Time frame: 24 weeks
Change in IQVIA Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 24 weeks
Change in The Knowledge, Attitude, and Self-Efficacy Asthma Questionnaire (KASEAQ)
Time frame: 24 weeks
Change in Feeling of Satisfaction with Inhaler (FSI-10) questionnaire
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- 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.
James Krings, MD MSc principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Maintenance ICS and Symptom Driven SABA and Symptom-driven budesonide/formoterol combination in people with Asthma in Children and Nonadherence, Medication, run by Washington University School of Medicine 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 6 inclusion and 6 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 19 Aug 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence to inhaler strategy delineated using an electronic inhaler sensor (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.