Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Real World and Genomic Data Based Asthma Insight Through Network Analysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
REGAIN Real World and Genomic Data Based Asthma Insight Through Network Analysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REGAIN
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 n200 2 asthma managed on stable biological therapy n200 3 type 2 asthma with prior treatment with at least 2 biological therapies n60 4 likely type 2 low asthma patients n200 5 asthma patients scheduled to be started de novo on biological therapies n120 and 6 healthy participants n400 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None