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NCT05111262 · ClinicalTrials.gov registry record · Phase 1
Symptom-driven ICS/LABA Therapy for Patients With Asthma Non-adherent to Daily Maintenance Inhalers
A Phase 1 study of Asthma and Nonadherence, Medication, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05111262: Active Phase 1 study of Asthma and Nonadherence, Medication, sponsored by Washington University School of Medicine.
NCT05111262 is a Phase 1 study of Asthma and Nonadherence, Medication that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 60 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05111262, a Phase 1 study of Asthma and Nonadherence, Medication, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
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-repo
Conditions Studied
Interventions
- DRUG Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA
Study Locations (1)
Missouri
- Washington University in St. Louis School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-12-16 |
| Est. Completion | 2025-11-30 |
| Phase | Phase 1 |
What the registry record for NCT05111262 still lists
NCT05111262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA is the first listed.
NCT05111262 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05111262 about?
NCT05111262 is a clinical study titled "Symptom-driven ICS/LABA Therapy for Patients With Asthma 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-adhere...
What is the current status of trial NCT05111262?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2021-12-16. Estimated completion is 2025-11-30.
What conditions does trial NCT05111262 study?
This clinical trial studies the following conditions: Asthma, Nonadherence, Medication.
What interventions are being tested in trial NCT05111262?
The interventions under investigation include: Adherence to symptom driven budesonide/formoterol as compared to adherence to maintenance ICS and symptom-driven SABA (DRUG).
Who is sponsoring clinical trial NCT05111262?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05111262 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05111262's enrollment target sits among peer trials
60 248th of 374 higher than 121 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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