Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-26 @ 5:51 PM
Study NCT ID:
NCT04997304
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2021-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Teva Asthma Predictive Analytics Study
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Utilizing Advances in Digital Inhaler Technology to Understand Heterogeneous Treatment Responses to Biologics in Severe Asthma
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is being completed to determine baseline inhalation parameters and patterns of use in patients receiving treatment with TEVA digital inhalers, to develop predictive models for asthma exacerbations and response to biologics using data collected from these devices.
Enrolled participants will complete questionnaires along with other study specific procedures. Additionally, in-person and phone visits will be performed.
Enrolled participants will complete questionnaires along with other study specific procedures. Additionally, in-person and phone visits will be performed.
Detailed Description:
All participants were provided an AirDuo® Digihaler™ and ProAirDuo® Digihaler™, which the participants could choose to use or not. This trial did not restrict participants from using other asthma treatments in addition to or in lieu of the Digihalers.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: