Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-29 @ 6:31 AM
Study NCT ID:
NCT01351792
Status:
TERMINATED
Last Update Posted:
2017-03-30
First Post:
2011-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Patients With Chronic Obstructive Pulmonary Disease (FAIR)
Sponsor:
Chiesi Farmaceutici S.p.A.
Organization:
Study Overview
Official Title:
A 12-week, Multicentre, Randomised, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® 100/6 (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Puffs b.i.d., Versus Symbicort® 200/6 (Budesonide 200 µg Plus Formoterol 6 µg/Actuation), 2 Inhalations b.i.d., on Parameters of Small Airway Function in Patients With Chronic Obstructive Pulmonary Disease.
Status:
TERMINATED
Status Verified Date:
2017-03
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:
FAIR
Brief Summary:
The purpose of the present study is to demonstrate the higher efficacy of small particles Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations b.i.d.), in terms of residual volume reduction over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.
Detailed Description:
Chronic obstructive pulmonary disease (COPD) is an incurable, debilitating and progressive disease that can be fatal. The recent Global Burden of Disease Study ranks COPD as the 6th leading cause of mortality and the 12th leading cause of morbidity world-wide. Furthermore, trends in the use of medical care resources indicate that the economic cost of COPD continues to rise in direct relation to the ageing population, the increase in prevalence of disease and the cost of new and existing medical and public health interventions.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-022895-30 | EUDRACT_NUMBER | None | View |