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Mometasone Furoate Dry Inhaler

Phase 3

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

Mometasone Furoate Dry Inhaler target and mechanism

ModalitySmall molecule

Also known as mometasone furoate dry powder inhaler

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Mometasone Furoate Dry Inhaler clinical trials

Mometasone Furoate Dry Inhaler · 1 trial · 1 indication

Phase 3 1
NCT00442117A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)Asthma
COMPLETED180 Analytics
PHASE3COMPLETED
A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.
Baseline and Week 12

FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.

Secondary Endpoints

Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12.
Baseline and Week 12
Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12.
Baseline and Week 12
Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12.
Baseline and Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MF-DPIEXPERIMENTALMF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day)
BUD-DPIACTIVE_COMPARATORBudesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day)

Interventions

NameTypeDescription
mometasone furoate dry powder inhalerDRUGMF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks.
Budesonide DPIDRUGBudesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects must be 12 years of age or older of either gender, who (and their parent/guardian if the subject is under the age of 20) must demonstrate their willingness to sign and write informed consent. * Subjects must have had a history of asthma for at least 6 months. * The su...

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Frequently asked questions about Mometasone Furoate Dry Inhaler

What is mometasone furoate dry inhaler?

Mometasone furoate dry inhaler is an investigational inhaled corticosteroid therapy being developed for asthma. It delivers mometasone furoate as a dry powder directly to the airways and is given as a 100 mcg dose. Organon & Co. (ticker OGN) is developing the product, which has completed Phase 3 clinical testing.

What is mometasone furoate dry inhaler used for?

Mometasone furoate dry inhaler is being studied for the treatment of asthma. It is an inhaled corticosteroid formulated as a dry powder for delivery to the lungs. The clinical program enrolled adolescents and adults with asthma, with participants aged 12 years and older of any sex.

Who makes mometasone furoate dry inhaler?

Organon & Co., which trades under the ticker OGN, is the developer of the mometasone furoate dry inhaler. The company is advancing the asthma asset, and the product is also referred to as mometasone furoate (MF) dry powder inhaler (DPI), 100 mcg.

What phase is mometasone furoate dry inhaler in?

Mometasone furoate dry inhaler is in Phase 3 development for asthma. It is an investigational product and is not described as approved. One Phase 3 trial has been completed, and no trials are currently listed as active. The completed study enrolled 180 participants.

What clinical trials is mometasone furoate dry inhaler in?

Mometasone furoate dry inhaler has been evaluated in one completed Phase 3 trial, NCT00442117, titled A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Asthmatics (Study P04880). The randomized, active-controlled study enrolled 180 participants with asthma aged 12 years and older and has completed.