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NCT05689983 · ClinicalTrials.gov registry record · Phase 1
Symptom-driven ICS/LABA Therapy for Adolescent Patients With Asthma Non-adherent to Daily Maintenance Inhalers
A Phase 1 study of Asthma in Children and Nonadherence, Medication, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05689983: Active Phase 1 study of Asthma in Children and Nonadherence, Medication, sponsored by Washington University School of Medicine.
NCT05689983 is a Phase 1 study of Asthma in Children and Nonadherence, Medication that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 40 participants, below the 204-participant average among 44 other Asthma in Children trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05689983, a Phase 1 study of Asthma in Children 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
- 40 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 Maintenance ICS and Symptom Driven SABA
- DRUG Symptom-driven budesonide/formoterol combination
Study Locations (1)
Missouri
- Washington University in St. Louis School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 1 |
What the registry record for NCT05689983 still lists
NCT05689983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 204-participant average among 44 other Asthma in Children trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Asthma in Children appearing as the primary indexed condition, and to 2 interventions - of which Maintenance ICS and Symptom Driven SABA is the first listed.
NCT05689983 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05689983 about?
NCT05689983 is a clinical study titled "Symptom-driven ICS/LABA Therapy for Adolescent 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 NCT05689983?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-04-01. Estimated completion is 2025-12-01.
What conditions does trial NCT05689983 study?
This clinical trial studies the following conditions: Asthma in Children, Nonadherence, Medication.
What interventions are being tested in trial NCT05689983?
The interventions under investigation include: Maintenance ICS and Symptom Driven SABA (DRUG), Symptom-driven budesonide/formoterol combination (DRUG).
Who is sponsoring clinical trial NCT05689983?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05689983 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 NCT05689983's enrollment target sits among peer trials
40 33rd of 44 higher than 12 of 44 other Asthma in Children trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma in Children 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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