Real World and Genomic Data Based Asthma Insight Through Network Analysis

Active, not recruiting

• Conditions: Asthma

• Registration Number: NCT06623435
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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

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.

Study Timeline

• Study Start: 2019-11-07
• Status Verified: 2024-09
• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1075

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma disease subtypes	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of responders versus non-responders	6 and 18 months	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.
Symptom status	6 and 18 months	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

Trial Locations

Locations (5)

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Mount Sinai Beth Israel; 🇺🇸 New York, New York, United States

Mount Sinai West; 🇺🇸 New York, New York, United States

Mount Sinai Morningside; 🇺🇸 New York, New York, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States