Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379288
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2006-09-19
Brief Title:
Study of Mometasone FuroateFormoterol Combination and FluticasoneSalmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids P04139
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A 1-Year Safety Study of Medium and High Doses of Mometasone FuroateFormoterol Combination Formulation and Medium and High Doses of FluticasoneSalmeterol in Persistent Asthmatics Previously Treated With Medium to High Doses of Inhaled Glucocorticosteroids
Status:
COMPLETED
Status Verified Date:
2022-02
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 purpose of this study is to evaluate the long-term safety of mometasone furoateformoterol MFF metered dose inhaler MDI 20010 mcg twice-a-day BID and MFF MDI 40010 mcg BID and two doses of fluticasonesalmeterol combination FSC 25050 mcg BID and 50050 mcg BID in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids ICS evaluator-blind
In addition the extrapulmonary effects on 24-hour plasma cortisol area under curve AUC of MFF MDI 20010 mcg BID MFF MDI 40010 mcg BID FSC MDI 25050 mcg BID and FSC MDI 50050 mcg BID will be evaluated
In addition the extrapulmonary effects on 24-hour plasma cortisol area under curve AUC of MFF MDI 20010 mcg BID MFF MDI 40010 mcg BID FSC MDI 25050 mcg BID and FSC MDI 50050 mcg BID will be evaluated
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