Ignite Creation Date:
2024-05-05 @ 11:06 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01258803
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2010-12-09
Brief Title:
A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma P06476 AM2
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A Randomized Evaluator-Blind Crossover Single Dose Study of the Bronchodilator Effect of Formoterol Fumarate in Combination With Mometasone Furoate Metered Dose Inhaler Delivered With and Without a Spacer Versus Placebo and Foradil Aerolizer in Children With Persistent Asthma Protocol No P06476
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:
A study to compare the bronchodilatory effect of a single dose of Mometasone FuroateFormoterol Fumarate MFF pressurized metered dose inhaler MDI delivered with and without an AeroChamber Plus with Flow-Vu Anti-Static Valved Holding Chamber spacer versus Placebo MDI combined with and without spacer and formoterol fumarate F dry powder inhaler DPI Participants were randomly assigned to 1 of 6 treatment sequences and each participant was to receive a single dose of each of 4 treatments in each period Each treatment period was separated by a 5 to 7 day washout period It assumed that a single dose MFF MDI 10010 microgram mcg delivered with a spacer would produce bronchodilation defined as a significant increase in forced expiratory volume in one second FEV1 area under the curve from 0 to 12 hours AUC0-12 hr when compared to placebo
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 |
|---|---|---|---|
| MK-0887A-178 | OTHER | Merck Research Laboratories | None |