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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

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
National Jewish Health
Coordinator of this site? Confirm its status
DenverUnited StatesUnknown status
Mount Sinai Morningside
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Mount Sinai Hospital
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Mount Sinai West
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Mount Sinai Beth Israel
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.