Recent Updates
Recently added Catalysts

mometasone furoate combination MDI 200

Phase 3

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment404

FDA Designations

No designations recorded

Clinical trial landscape

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.

Unlock Study Endpoints

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
Unlock Study Design Details

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...

Unlock Eligibility Criteria

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 small molecule being developed for the treatment of asthma. It is a metered-dose inhaler formulation that combines mometasone furoate with formoterol. The drug is intended for patients with persistent asthma who have previously been treated with inhaled glucocorticosteroids.

Who makes mometasone furoate combination MDI 200?

Mometasone furoate combination MDI 200 is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. Organon is conducting clinical development of this combination inhaler for the respiratory condition asthma.

What phase is mometasone furoate combination MDI 200 in?

Mometasone furoate combination MDI 200 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial for this asthma treatment has been completed, with results expected to inform potential regulatory submissions.

What clinical trials is mometasone furoate combination MDI 200 in?

Mometasone furoate combination MDI 200 has one completed Phase 3 clinical trial registered as NCT00379288. This study, titled 'Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)', enrolled 404 participants aged 12 years and older with asthma.

Is mometasone furoate combination MDI 200 the same as mometasone furoate/formoterol?

Yes, mometasone furoate combination MDI 200 is a combination product containing mometasone furoate and formoterol. The clinical trial NCT00379288 refers to it as the 'Mometasone Furoate/Formoterol Combination'. It is administered via a metered-dose inhaler (MDI) at a strength of 200 mcg.