Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394355
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2006-10-31
Brief Title:
Effects of Mometasone Furoate Dry Powder Inhaler Fluticasone Propionate and Montelukast on Bone Mineral Density in Asthmatics Study P03418
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
Comparative Study of the Effect of Two Doses of Mometasone Furoate Dry Powder Inhaler 200 mcg and 400 mcg QD PM Fluticasone Propionate 250 mcg BID and Montelukast 10 mg QD PM on Bone Mineral Density in Adults With Asthma
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:
This is a randomized multi-center parallel-group active-controlled double-blind study evaluating the effects of mometasone furoate MF dry powder inhaler DPI on bone mineral density BMD in subjects with asthma The mean percent change in lumbar spine BMD from the averaged baseline value the average of the two scan results prior to treatment to the endpoint of treatment time point the average of the last two valid post-baseline scan results during treatment for the comparison of MF DPI 400 mcg daily in the evening versus montelukast ML 10 mg daily in the evening
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT No 2004-002930-21 | None | None | None |
| Doc ID 3387777 | None | None | None |