Could a 'Use-When-Needed' inhaler help teens with asthma?
NCT ID NCT05689983
First seen Jun 26, 2026 · Last updated Aug 20, 2026 · Updated 2 times
Summary
This study tests whether a symptom-driven inhaler (budesonide/formoterol) works better for teens with asthma who often forget their daily maintenance inhalers. Researchers will compare adherence and asthma flare-ups between the standard daily inhaler plus rescue inhaler group and the symptom-driven group. The goal is to find a simpler approach that reduces hospitalizations and improves asthma control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- budesonide/formoterol combination (Symbicort)
- What this could lead to
- If this approach works, it could offer a simpler, more effective way for teens to manage asthma without needing to remember daily inhalers.
- What could go wrong
- This is a small early-phase study with only 40 participants, so results may not apply to everyone. The symptom-driven strategy might not control asthma as well as daily maintenance therapy in some patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
55 people
The number who actually took part.
- Started
-
Apr 2022
- Finished
-
Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 17 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Able to understand and provide informed consent. 2. Age 18-75 at the time of study enrollment. 3. Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICS treatment and as needed SABA for at least 6 months prior to enrollment. 4. 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. 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. 6. iPhone or Android smartphone with an active data plan and willingness to use the Adherium device. Exclusion Criteria: 1. 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. 2. Current use of a biologic medication or investigational treatment for asthma. 3. History of asthma requiring ICU admission in the last year. 4. 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. 5. Any clinically significant abnormalities on physical exam, laboratory testing, or baseline diagnostic testing that the study team believes will make the study unsafe. 6. Patients who do not complete at least 70% of the twice-daily texts during the two weeks after screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110, United States
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