An interventional study of BREATHE Intervention and Control Intervention in Asthma, sponsored by Columbia University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Columbia University · Not applicable, Interventional, and Supportive care
This study is an efficacy-implementation trial to:
Black adults with asthma are an appropriate target for shared decision-making (SDM) interventions that support disease self-management as Black adults experience a higher asthma burden and worse clinical outcomes than non-Black adults and/or children with asthma of any racial-ethnic background. To date, the application of SDM and community-based interventions targeting Black adults have failed to address these disparities. Therefore, the investigator used patient input to develop BREATHE - BRief intervention to Evaluate Asthma THErapy - a 9-minute SDM intervention focused on reducing the impact of erroneous beliefs on asthma control - and established its efficacy in this health disparity population. This intervention is unique in that it is a one-time brief, tailored intervention integrated into office visits, using the patient's own provider as the interventionist (e.g. scalable). A previously conducted pilot trial demonstrated high fidelity to BREATHE delivery and improved asthma control and reduced symptoms among BREATHE participants compared to a dose-matched attention control condition.
We will conduct post-trial mixed-method interviews with patient participants, their loved ones, and PCPs using evaluation frameworks to determine satisfaction with, and acceptability of, the active and control interventions.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 400 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (participants):
Patients participants will
Exclusion Criteria (participants):
Inclusion Criterion (clinicians):
1. those who manage a panel of adult asthma patients
Inclusion Criteria (loved ones):
Exclusion Criteria (loved ones):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
Behavioral: BREATHE Intervention
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
Behavioral: Control Intervention
BREATHE utilizes Primary Care Providers (PCPs) to deliver a 4-step script that was created by and tailored to Black adults' asthma and inhaled corticosteroid beliefs, as well as their Asthma Control Questionnaire (ACQ) score, measured just prior to the medical visit. Step 1: Raise the subject (1½ minute). Step 2: Provide feedback (1½ minutes). Step 3: Enhance engagement (3 minutes). Step 4: Shared decision-making (3 minutes).
The control intervention will be a 9-minute scripted discussion tailored to living a health lifestyle. Step 1: Review of BMI, current diet and exercise (3 minutes). Step 2: Diet/exercise counseling (3 minutes). Step 3: Plan for goal attainment (3 minutes).
Mean Asthma Control Questionnaire Score
Asthma control as measured by improvements in Asthma Control Questionnaire (ACQ) score, a 6-item validated and widely used measure of asthma control. Each question is rated from 0 to 6. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. The overall ACQ score is the mean score of all 6 items. Lower mean scores indicate greater asthma control, higher mean scores indicate lesser asthma control.
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention)
Mean Shared Decision Making-Questionnaire-9 Score
The Shared Decision Making (SDM) Questionnaire-9, is a patient reported, 9-item validated instrument that consists of nine statements that measure the decisional process in medical visits from both patients' and physicians' perspectives. Each statement is rated on a six-point scale from "completely disagree" (0) to "completely agree" (5). The raw total score of all items range from 0-45. Lower scores indicate lower levels of shared decision making between provider and patient (in this study as it pertains to asthma treatment) and higher scores indicate higher levels of shared decision making.
Time frame: Baseline (immediately post-intervention)
Mean Medication Adherence Report Scale - Asthma Score
Inhaled corticosteroid adherence as measured by the Medication Adherence Report Scale - Asthma (MARS-A). Participants are asked to rate the frequency with which they engage in each of the adherence-related behaviors on a five-point scale, where 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. Scores for each item are summed to give a total score, with higher scores indicating higher levels of reported adherence.
Time frame: Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention)
Mean Asthma Quality of Life Questionnaire Score
Asthma quality of life improvements as measured by the Asthma Quality of Life Questionnaire (AQLQ), a 32-item validated and widely-used measure consisting of 4 domains: symptoms (11 items), emotions (5 items), environment (4 items), and activities (12 items). Each item is measured on a 7-point Likert scale (7 = not impaired at all, 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains. Lower mean scores indicate lower quality of life due to asthma.
Time frame: Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention)
Mean Asthma Impairment and Risk Questionnaire Score
Asthma Impairment and Risk Questionnaire (AIRQ) is a 10-item valid and reliable survey that measures bot domains of control: symptom impairments and risk for uncontrolled asthma. AIRQ™ score ranges from 0-10, measured by total number of YES answers. Score tally of 0-1 indicates well controlled asthma, scores 2-4 indicate not well controlled asthma, and scores 5-10 indicate very poorly controlled asthma.
Time frame: Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention)
Number of participants who completed post-trial interviews
Qualitative post-trial interviews will be conducted with patient participants, their loved ones, and primary care providers to determine the satisfaction with, and acceptability of the intervention. The interviews will be analyzed using a directed content analysis to determine themes within the interviews.
Time frame: up to 3 months (post-trial)
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Feb 2028, 61 months after the start.
Of 599 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 61 months is above that.
Counting every sponsor, half of 649 studies reached it within 23 months; a quarter within 10 and three quarters within 48.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 23, 2026: primary completion Jul 2026 → Feb 2028 and completion Jul 2026 → Feb 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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