Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476073
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2007-05-17
Brief Title:
Efficacy and Safety of Flutiform pMDI in Adult Patients With Mild to Moderate-severe Reversible Asthma
Sponsor:
Mundipharma Research Limited
Organization:
Mundipharma Research Limited
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Open parallel group design The study has a screening phase and a 12 week treatment phase Subjects will be randomised to treatment in a 11 ration
Detailed Description:
This is a study involving a 12 week treatment phase During the treatment phase subjects receive FLUTIFORM or Sertetide Efficacy will be assessed by lung function tests and asthma symptoms sleep disturbance Safety will be assessed by adverse events vital signs lab tests and ECGs
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