NCT05111262Active, not recruitingPhase 1/2
Symptom-driven ICS/LABA Therapy for Patients With Asthma Non-adherent to Daily Maintenance Inhalers
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 27 Oct 2021
- Start date
- 16 Dec 2021
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Asthma
- NCT number
- NCT05111262
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 16 Dec 2021 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of a biologic medication or investigational treatment for asthma.
Other illness
- 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.
- History of asthma requiring ICU admission in the last year.
Lab values
- Any clinically significant abnormalities on physical exam, laboratory testing, or baseline diagnostic testing that the study team believes will make the study unsafe.
Other
- 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.
- Patients who do not complete at least 70% of the twice-daily texts during the two weeks after screening.
Who the study is looking for
- 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.
Age in the registry: 12 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University in St. Louis, School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.