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Asthma Symptom Perception Study
NCT06612294 · View on ClinicalTrials.gov ↗
Study Summary
Asthma affects 8% of the United States population ages \>60 years and causes considerable harm: older adults are 4 times more likely to die from asthma and have twice the risk of hospitalization. The burden of asthma is notably greater among minoritized older adults. Research suggests that perception of expiratory airflow limitation may be a major determinant of asthma outcomes in older adults, and that older adults are substantially less aware of airway obstruction than younger adults. These observations suggest that perception of airflow limitation is a potential target for improving outcomes of older patients with asthma. The research team completed a pilot randomized controlled trial (RCT) of an intervention that trains older adults with asthma to better perceive expiratory airway obstruction through feedback via peak expiratory flow (PEF) prediction and couples this feedback with motivational interviewing (MI) to promote change in asthma self-management behaviors. Compared to an attention control, the intervention improved PEF, perception of airflow limitation and asthma control. In this project, the research team will conduct a fully powered RCT to test the intervention's efficacy among 300 adults ages ≥60 years with uncontrolled asthma who are on controller medications (daily maintenance or as needed) recruited from underserved inner-city medical practices in New York City. Patients will be randomized to the intervention or a time and attention matched educational control. The intervention and control will be delivered in 3 sessions over 6 weeks. The study will test the impact of the intervention on perception of expiratory airflow limitation in older adults with asthma, examine the efficacy of the intervention for improvements in lung function (PEF), self-reported asthma control (Asthma Control Questionnaire \[ACQ\] scores), quality of life (Asthma Quality of Life Questionnaire \[AQLQ\] scores), and emergency department and hospital use, and test the interve
Conditions Studied
Interventions
- BEHAVIORAL PEF Interventional Session
- BEHAVIORAL Control Sessions
- BEHAVIORAL Control Booster
- BEHAVIORAL Active booster
Study Locations (2)
New York
- Ichan School of Medicine at Mount Sinai — New York
- Albert Einstein College of Medicine — The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-09-18 |
| Est. Completion | 2028-12-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06612294
The ClinicalTrials.gov registry entry for NCT06612294 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 946 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions — of which PEF Interventional Session is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06612294 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06612294 about?
NCT06612294 is a clinical study titled "Asthma Symptom Perception Study". Asthma affects 8% of the United States population ages \>60 years and causes considerable harm: older adults are 4 times more likely to die from asthma and have twice the risk of hospitalization. The burden of asthma is notably greater among minoritized older adults. Research suggests that perceptio...
What is the current status of trial NCT06612294?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2024-09-18. Estimated completion is 2028-12-22.
What conditions does trial NCT06612294 study?
This clinical trial studies the following conditions: Asthma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06612294?
The interventions under investigation include: PEF Interventional Session (BEHAVIORAL), Control Sessions (BEHAVIORAL), Control Booster (BEHAVIORAL), Active booster (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06612294?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 946 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06612294 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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