Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-01 @ 8:22 AM
Study NCT ID:
NCT01006135
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2009-10-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region
Status:
COMPLETED
Status Verified Date:
2014-03
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:
None
Brief Summary:
The objective of this observational study is to collect and evaluate data on Health Related Quality of Life (HRQoL) of Spiriva delivered by HandiHaler, using disease specific SGRQ in the national samples of Central \& Central European patients with varying severities of chronic obstructive pulmonary disease (COPD) in the real life setting over the 6 months.
Detailed Description:
Study Design:
an open-label, uncontrolled and single arm post-marketing surveillance study
an open-label, uncontrolled and single arm post-marketing surveillance study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: