Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163527
Status:
COMPLETED
Last Update Posted:
2016-12-02
First Post:
2005-09-12
Brief Title:
Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma 12 to 70 y BY217M2-013
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A 24-Week Double-Blind Parallel Group Placebo and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Chronic Asthma
Status:
COMPLETED
Status Verified Date:
2016-09
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:
Bronchial asthma is among the worlds most prevalent diseases Roflumilast is a novel orally active selective enzyme inhibitor phosphodiesterase 4 inhibitor which has shown effectiveness in the treatment of asthma
The aim of the study is to investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily The study duration consists of a baseline period 2 to 6 weeks and a treatment period 24 weeks The study will provide further data on safety tolerability and effectiveness of roflumilast
The aim of the study is to investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily The study duration consists of a baseline period 2 to 6 weeks and a treatment period 24 weeks The study will provide further data on safety tolerability and effectiveness of roflumilast
Detailed Description:
None
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