Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04656223
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2020-11-30
Brief Title:
Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
Status:
COMPLETED
Status Verified Date:
2024-03
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:
ADITION
Brief Summary:
This study is designed as a multicenter observational non-interventional open label 26-week study in order to observe how asthma control changes under treatment with Mometasone FuoratIndacaterol Glycopyrronium MFINDGLY Breezhaler sensor system or under treatment with fixed-dose combination FDC triple therapy after 26 weeks of treatment
Detailed Description:
Subjects in one group will receive MFINDGLY together with the Propeller add-on sensor for the Breezhaler and access to the smartphone app according to label Subjects in the other group will receive any triple FDC according to label The physicians decision to initiate or switch a patient to MFINDGLY Breezhaler system or any other triple FDC must have been taken prior to and independently from the decision to include the patient in the study
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