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mometasone furoate dry inhaler

Phase 3

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

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

Clinical trial landscape

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 used for?

Mometasone furoate dry inhaler is an investigational small molecule being developed for the treatment of asthma. It is administered via a dry powder inhaler and is currently in Phase 3 clinical development. The drug is being studied in patients aged 12 years and older with asthma.

Who makes mometasone furoate dry inhaler?

Mometasone furoate dry inhaler is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma.

What phase is mometasone furoate dry inhaler in?

Mometasone furoate dry inhaler is in Phase 3 clinical development for asthma. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 180 participants, but the drug remains under clinical investigation.

What clinical trials is mometasone furoate dry inhaler in?

Mometasone furoate dry inhaler has one completed Phase 3 clinical trial registered as NCT00442117, titled 'A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Asthmatics (Study P04880)'. The trial enrolled 180 participants aged 12 years and older with asthma and used an active control.

How does mometasone furoate dry inhaler work?

Mometasone furoate dry inhaler is a corticosteroid that works by reducing inflammation in the airways, which helps to improve asthma control. It is administered through a dry powder inhaler device, delivering the medication directly to the lungs to manage asthma symptoms.