Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-03 @ 9:15 PM
Study NCT ID:
NCT02927795
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2016-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OTIVACTO Spain Non Interventional Study
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice
Status:
COMPLETED
Status Verified Date:
2019-09
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 is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.
Detailed Description:
Purpose:
Study Design:
Study Design:
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: