NCT06623435Completed
Real World and Genomic Data Based Asthma Insight Through Network Analysis
REGAIN: Real World and Genomic Data Based Asthma Insight Through Network Analysis
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
A retrospective and prospective observational study of asthma designed to determine real-world and molecular description of asthma according to treatment and type 2 biology
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1075 (actual)
- First submitted
- 30 Sept 2024
- Start date
- 7 Nov 2019
- Primary completion date
- 16 Jun 2025
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Asthma
- NCT number
- NCT06623435
What you commit to
- Study type: Observational
- Participants enrolled: 1075
- From 7 Nov 2019 to the primary completion date, 16 Jun 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \>10 pack per year tobacco, current smoker of cigarettes, e-cigarettes or other inhalational drug use.
- 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
Other illness
- Clinically significant lung disease based on imaging or clinical history other than asthma as determined by an allergist or pulmonologist
- 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
- 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
Lab values
- Anemia with hemoglobin level ˂9 mg/dl at the time of study enrollment
- Serum cotinine \> 1 ng/ml
Age
- Age \< 18
Other
- Currently pregnant or breastfeeding
- Vaccination within 4 weeks
Who the study is looking for
- 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)
- 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)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Mount Sinai Morningside Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai West Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Beth Israel Coordinator of this site? Confirm its status | New York | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.