Asthma insights: 1,000-Patient study aims to uncover hidden disease subtypes
NCT ID NCT06623435
First seen Jun 26, 2026 · Last updated Aug 19, 2026 · Updated 3 times
Summary
This observational study is looking at over 1,000 adults with asthma to better understand different types of the disease. Researchers will combine real-world medical records with genetic data to see how patients respond to various treatments. The goal is to identify asthma subtypes based on biology and symptom control, which could lead to more personalized care in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could help doctors better classify asthma types and personalize treatments based on a patient's biology and real-world response.
- What could go wrong
- This is an observational study, not a treatment trial. It may not lead to immediate changes in care, and findings might not apply to all asthma patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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1,075 people
The number who actually took part.
- Started
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Nov 2019
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Specific groups of asthma patients as outlined and healthy volunteers
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Asthma Participants: * Age \>18 * Clinical diagnosis of asthma verified by a specialist physician (allergist or pulmonologist) and one or more of the following: * Historical variability of airflow limitation via classic reversibility criteria (\> 12%, 200 ml within past 10 years). * Historical methacholine challenge with PC20 \< 8 mg/ml (within past 10 years). * FEV1 variability, between two clinic visits, of 20% within the past 5 years either with improvement according to appropriate therapy or decrease in lung function upon withdrawal or decrease of therapy. * Elevated FeNO \> 50 ppb at least once historically (within past 10 years). * \< 10 pack per year personal tobacco use and not a current smoker of cigarettes or other inhalational tobacco (e-cigarette, marijuana or other inhalational drug use). * At least partial response of presenting symptoms to GINA Step 1-4 asthma treatment (ICS or ICS/LABA as determined by study physician investigators) Exclusion criteria for Asthma Participants: * \>10 pack per year tobacco, current smoker of cigarettes, e-cigarettes or other inhalational drug use. * Clinically significant lung disease based on imaging or clinical history other than asthma as determined by an allergist or pulmonologist * Currently pregnant or breastfeeding * Anemia with hemoglobin level ˂9 mg/dl at the time of study enrollment Inclusion Criteria for Healthy Controls: * Age \> 18 * No current smoking (quit \> 6 months previously) confirmed by serum cotinine level \< 1 ng/ml * \< 10 pack year tobacco history * No current respiratory symptoms (cough wheeze, dyspnea) * No current lung disease or other significant medical comorbidity (see exclusion criteria below) Exclusion Criteria for Healthy Controls: * Age \< 18 * Diagnosis of asthma, COPD, emphysema, bronchiectasis or other significant lung disease * Treatment or a history of malignancy currently or within the past 5 years, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin * Treatment of inflammatory disease or autoimmune disease such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis or others * Treatment with immune modulating medications for a health condition including any of the following (systemic glucocorticoids, sirolimus, tacrolimus, anti-TNF abatacept, azathioprine, methotrexate, cyclosporine, cyclophosphamide, immunoglobulin, mycophenolate, rituximab, plaquenil or others) * Treatment with anti-IL5, anti-IgE and anti-IL4 receptor alpha for non-asthma indications * Vaccination within 4 weeks * History of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, gastrointestinal, uncontrolled diabetes, uncontrolled infectious disease, HIV infection, cerebrovascular, or other significant medical illness or disorder which in the judgment of the investigator could impact the participant as a healthy control * Serum cotinine \> 1 ng/ml
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mount Sinai Beth Israel
New York, New York, 10003, United States
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Mount Sinai Hospital
New York, New York, 10029, United States
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Mount Sinai Morningside
New York, New York, 10027, United States
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Mount Sinai West
New York, New York, 10019, United States
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National Jewish Health
Denver, Colorado, 80206, United States
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