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AsthmaREGAINNCT06623435

Real World and Genomic Data Based Asthma Insight Through Network Analysis

An observational study of Asthma, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Asthma
Type of treatment
Pill or oral medicine
How many people
1,075 participants
Where
5 sitesUnited States
Study dates
7 Nov 2019to 16 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Specific groups of asthma patients as outlined and healthy volunteers

Who may be able to join

  • 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).
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  • < 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)

Who cannot join

  • >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
  • Age < 18
  • Diagnosis of asthma, COPD, emphysema, bronchiectasis or other significant lung disease
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • National Jewish Health

    Denver, Colorado, 80206

  • Mount Sinai Beth Israel

    New York, New York, 10003

  • Mount Sinai West

    New York, New York, 10019

  • Mount Sinai Morningside

    New York, New York, 10027

  • Mount Sinai Hospital

    New York, New York, 10029

Other trials in United States

About this study

Official title: REGAIN: Real World and Genomic Data Based Asthma Insight Through Network Analysis

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

Read the detailed description

REGAIN is a retrospective and prospective asthma cohort study designed to determine real-world molecular description of asthma according to treatment and type 2 biology. The researchers will enroll 5 pre-specified groups of participants with asthma of specific interest for mechanistic analyses according to clinically determined type 2 inflammatory endotype and response to therapy with inhaled steroids and other inhaled controllers with or without asthma biologics. This study is conducted at asthma specialty programs at Mount Sinai National Jewish Health Respiratory Institute in New York and National Jewish Health, Denver, Colorado, USA. Participants with asthma meeting specific inclusion criteria were identified and enrolled by screening electronic medical records from pulmonary and allergy specialty programs. Targeted populations included 5 categories of asthma patients as outlined in Table 1 including the following: (1) patients with type 2 asthma with symptom control at time of enrollment (ACT > 20) on standard Global Initiative For Asthma (GINA) step therapy (n=200) (2) asthma managed on stable biological therapy (n=200), (3) type 2 asthma with prior treatment with at least 2 biological therapies, (n=60), (4) likely type 2 low asthma patients (n=200), (5) asthma patients scheduled to be started de novo on biological therapies (n=120), and (6) healthy participants (n=400). Healthy participants were recruited in New York and Denver by community advertising. An optional study component employing a mobile phone application, use of digital inhaler monitors, and home digital peak flow will contribute data regarding medication use and lung function in the community and collect environmental data impacting asthma using geolocation data.

Conditions
Asthma
Keywords
asthma, phenotyping, transcriptomics, network analysis, genomics, biologics
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06623435
Study groupRoleWhat they receive
Type 2 Step Therapy AsthmaParticipants in this group must meet criteria for asthma diagnosis and type 2 asthma status (1) Exhaled nitric oxide (FeNO) > 50 ppb at any clinical care time point (2) at least one blood eosinophil count (BEC) > 300/uL at any clinical care time point (3) eosinophilia by induced sputum or bronchoscopy (> 3%) if available historically, performed as part of clinical care) and be on inhaled step therapy according to the Global Initiative for Asthma 2018 Step Therapy 1-5 treatment. They can not be on chronic oral corticosteroids or biologic therapy and must have an Asthma Control test (ACT) of 20 or greater.
Likely Type 2 Low Step Therapy AsthmaParticipants with likely type 2 low asthma (exhaled nitric oxide-FeNO < 25 ppb AND blood eosinophil count (BEC) < 200/uL AND no eosinophilia by induced sputum or bronchoscopy if available historically or as obtained during clinical care. On inhaled step therapy according to the Global Initiative for Asthma 2018 Step Therapy 1-5 treatment. They cannot be on chronic oral corticosteroids or biologic therapy and can have any value for Asthma Control test (ACT)
Stable Biologics AsthmaParticipants included in the stable biological cohort must meet criteria for asthma diagnosis. The patients must also be on biological therapy for at least 4 months at enrollment. These participants needed to have an ACT of 20 or greater at time of enrollment, or if ACT 16-19 but they had GINA symptom control level 1-2, then they are considered partly controlled and were included in this group.
De Novo Biologics AsthmaEither 2 type 2 or type 2 low characteristics Asthma participants with uncontrolled asthma on inhaled therapy (Global Initiative for Asthma 2018) Any asthma control test score (ACT) Starting a clinically prescribed biologic therapy for asthma Not on another biologic therapy for at least 4 months
Failed Multiple Biologics AsthmaEither 2 type 2 or type 2 low characteristics. Participants included in this group must report prior biological treatment and having stopped treatment with at least 2 prior asthma biologics. They could be on or off biologic therapy at enrollment and have any level of asthma control by asthma control test and GINA at the time of enrollment.
Healthy participantsHealthy individuals with no respiratory symptoms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asthma disease subtypes

    Description of asthma disease subtypes according to type 2 and non-type 2 biology and control or lack of control along a range of asthma treatments.

    Measured: 18 months

Secondary outcomes (2)

  1. Number of responders versus non-responders

    Control on GINA Step 1-5 therapy will be defined by an ACT >20. Control on biological therapies will be defined by ACT > 20, or if ACT 16-19, achieving "partly controlled" status in according to GINA, or achieving a 50% reduction in oral corticosteroid (OCS) dose if patient is OCS dependent.

    Measured: 6 and 18 months

  2. Symptom status

    The proportion of participants achieving or maintaining symptom control, exacerbation control, both of these, or those achieving clinical remission at 6 and 18 months among asthma subgroups

    Measured: 6 and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start7 Nov 2019
  3. Primary completion16 Jun 2025
  4. Study completion16 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
1,075 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06623435
Sponsor's protocol ID
GCO 19-0358
Acronym
REGAIN
Status last verified
Mar 2026
First submitted
30 Sep 2024
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Publications

  • Kasarskis A, Wang E, Bryce PJ, Savic R, Pan Q, Weisman R, Barnhart E, Sifuentes A, Mosso E, Zhang L, Lee E, Zhang Z, Hao K, Schadt E, Nestle F, de Rinaldis E, Rogers L. Real-world and Genomic data-based Asthma Insights through Network Analysis (REGAIN study): protocol for a novel retrospective and prospective longitudinal asthma cohort study. BMJ Open. 2026 Apr 15;16(4):e104380. doi: 10.1136/bmjopen-2025-104380.

    PubMed 41985945

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Icahn School of Medicine at Mount Sinai at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma disease subtypes (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06623435, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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