AzTrials
AzTrials

AsthmaPhase 1/2NCT05111262

Symptom-driven ICS/LABA Therapy for Patients With Asthma Non-adherent to Daily Maintenance Inhalers

A Phase 1/2 study testing Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA in people with Asthma and Nonadherence, Medication, run by Washington University School of Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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 75 years
Conditions the study is for
Asthma, Nonadherence, Medication
What is being tested?
Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
16 Dec 2021to 30 Nov 2028
Phase
Phase 1/2
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 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Able to understand and provide informed consent.
  • Age 12-75 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. Adolescents age 12-17 with an ACT score 12-25 will be considered eligible.
  • 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

Other trials in United States

About this study

Official title: Symptom-driven Combination Inhaled Corticosteroids and Long-acting Beta Agonist Therapy for Patients With Asthma Who Are Identified as Non-adherent to Daily Maintenance Inhalers

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 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).

Being tested
Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA
Medical subject headings
Asthma, Medication Adherence

What participants receive

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

  • Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABADrug

    In this study, we propose a pragmatic, pilot, open-label trial where we are comparing adherence to different inhaler regimens. Patients who were previously sub-optimally adherent to maintenance ICS inhalers will either continue receiving maintenance ICS inhalers and symptom-driven SABA inhalers or symptom-driven ICS/LABA inhalers only.

Study groups in NCT05111262
Study groupRoleWhat they receive
As needed inhaled corticosteroid and long-acting beta-agonistActive comparatorSymptom-driven ICS/LABA treatment strategy
Receives: Drug: Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA
Standard therapy: maintenance inhaled corticosteroid and as needed short-acting beta-agonistNo interventionContinue maintenance ICS and SABA therapy

What is being measured

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

  1. 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)

  1. 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

  2. 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

  3. ICS exposure

    Converted cumulative dose of ICS between groups.

    Measured: 24 weeks

  4. Adverse and serious adverse events

    Occurrence of any severe and non-severe adverse events between groups.

    Measured: 24 weeks

  5. Change in Asthma Control Questionnaire (ACQ)

    Change in Asthma Control Questionnaire (ACQ) from baseline to the final study visit.

    Measured: 24 weeks

  6. Change in asthma control test (ACT)

    Change in Asthma Control Test (ACT) from baseline to the final study visit.

    Measured: 24 weeks

  7. Change in Asthma Quality of Life Questionnaire (AQLQ)

    Change in Asthma Quality of Life Questionnaire (AQLQ) from baseline to the final study visit.

    Measured: 24 weeks

  8. 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.

    Measured: 24 weeks

  9. 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.

    Measured: 24 weeks

  10. 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.

    Measured: 24 weeks

  11. 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.

    Measured: 24 weeks

Timeline

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

  1. First posted8 Nov 2021
  2. Study start16 Dec 2021
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05111262
Sponsor's protocol ID
202108173
Other IDs
KL2TR002346, UL1TR002345
Status last verified
Sep 2025
First submitted
27 Oct 2021
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Krings JG, Wojcik KM, Chen V, Sekhar TC, Harris K, Zulich A, Sumino K, Brownson R, Lenze E, Castro M. Symptom-driven inhaled corticosteroid/long-acting beta-agonist therapy for adult patients with asthma who are non-adherent to daily maintenance inhalers: a study protocol for a pragmatic randomized controlled trial. Trials. 2022 Dec 5;23(1):975. doi: 10.1186/s13063-022-06916-3.

    PubMed 36471430

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA in people with Asthma 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: under way, not looking for participants, 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. 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?

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?

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?

On the ClinicalTrials.gov record for NCT05111262, 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 19 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in