Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01471340
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2011-11-10
Brief Title:
A Serious Asthma Outcome Study With Mometasone FuroateFormoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over P06241
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A 26-Week Randomized Double-Blinded Active Controlled Study Comparing the Safety of Mometasone FuroateFormoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma Protocol No P06241 Also Known as P202
Status:
COMPLETED
Status Verified Date:
2024-04
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:
SPIRO
Brief Summary:
The purpose of this study is to test the safety of DULERA DULERA is a pressurized metered-dose inhaler MDI that contains two drugs combined namely mometasone and formoterol in a single inhaler Mometasone is an inhaled corticosteroid ICS which reduces the inflammation in the airways Formoterol is a long-acting beta 2 agonist LABA which helps to relax the muscles of the airways in the lungs making it easier to breathe In combination mometasone and formoterol are used for the treatment of asthma This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events hospitalization intubation and death compared to participants taking an ICS alone The primary safety hypothesis is that the time-to-first serious asthma outcome SAO with mometasone furoateformoterol MFF MDI twice daily BID is non-inferior to that with mometasone furoate MF MDI BID in adolescents and adults with persistent asthma If non-inferiority is achieved the key secondary safety hypothesis of superiority of MFF over MF will be assessed
Detailed Description:
Amendments 2 and 3 are specific to Brazil all other countries will enroll patients under Amendment 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-202 | OTHER | Merck Protocol Number | None |
| 2011-002142-13 | EUDRACT_NUMBER | None | None |