Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476099
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2007-05-18
Brief Title:
Efficacy and Safety Study of BeclometasoneFormoterol Single Inhaler in Patients With COPD
Sponsor:
Chiesi Farmaceutici SpA
Organization:
Chiesi Farmaceutici SpA
Study Overview
Official Title:
A 48-week Double Blind Double Dummy Randomised Multinational Multicentre 3-arm Parallel Group Clinical Study of Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus Fixed Combination Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To evaluate the 1-year efficacy and safety of the fixed combination beclometasoneformoterol pMDI in a twice daily regimen in patients with stable severe COPD
Detailed Description:
The purpose of this study is to evaluate the long-term efficacy and safety of the fixed combination beclometasoneformoterol pMDI in a twice daily regimen in patients with stable severe COPD Patients are randomised to receive either beclometasoneformoterol or budesonideformoterol DPI or formoterol DPI during 48 weeks of treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-002489-20 | EUDRACT_NUMBER | None | None |