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mometasone furoate combination MDI 200

Phase 3

Asthma | Small molecule | Respiratory |Organon & Co.|Trials Updated: May 20, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment404

FDA Designations

No designations recorded

mometasone furoate combination MDI 200 clinical trials

mometasone furoate combination MDI 200 · 1 trial · 1 indication

Phase 3 1
NCT00379288Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)Asthma
COMPLETED404 Analytics
PHASE3COMPLETED
Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

The Number of All Randomized Subjects Reporting Adverse Events (AEs).
1 year

AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MF/F 200/10 mcg BIDEXPERIMENTAL -
MF/F 400/10 mcg BIDEXPERIMENTAL -
F/SC 250/50 mcg BIDACTIVE_COMPARATOR -
F/SC 500/50 mcg BIDACTIVE_COMPARATOR -

Interventions

NameTypeDescription
mometasone furoate combination MDI 200/10 mcg BIDDRUGMF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
mometasone furoate combination MDI 400/10 mcg BIDDRUGMF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
Fluticasone/Salmeterol 250/50 mcg BIDDRUGF/SC 250/50 twice daily for 1 year
Fluticasone/Salmeterol 500/50 mcg BIDDRUGF/SC 500/50 twice daily for 1 year
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects of either sex and any race, at least 12 years of age, with a diagnosis of asthma of at least 12 months. * Use of medium or high daily dose of ICS (alone or in combination with long-acting beta-agonist \[LABA\]) for at least 12 weeks prior to Screening and have been on...

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Frequently asked questions about mometasone furoate combination MDI 200

What is mometasone furoate combination MDI 200 used for?

Mometasone furoate combination MDI 200 is an investigational inhaled therapy being developed for the treatment of asthma. It is a fixed-dose combination product delivered by metered dose inhaler and is intended for patients with persistent asthma, including those previously treated with inhaled glucocorticosteroids.

Who is developing mometasone furoate combination MDI 200?

Mometasone furoate combination MDI 200 is being developed by Organon & Co., which trades on the New York Stock Exchange under the ticker OGN. Organon is the sponsor responsible for the clinical development program for this asthma candidate.

What phase is mometasone furoate combination MDI 200 in?

Mometasone furoate combination MDI 200 is in Phase 3 clinical development for asthma. The program includes one completed Phase 3 trial. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is mometasone furoate combination MDI 200 in?

Mometasone furoate combination MDI 200 has been studied in one Phase 3 trial, NCT00379288, titled Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139). The trial is completed and enrolled 404 participants aged 12 years and older.

How was the Phase 3 trial of mometasone furoate combination MDI 200 designed?

The completed Phase 3 trial NCT00379288 was a randomized, active-controlled study of 404 participants with persistent asthma who had previously been treated with inhaled glucocorticosteroids. It was not double-blind and enrolled patients aged 12 years and older of all sexes. Healthy volunteers were not included.