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Mometasone furoate/formoterol combination

Phase 3

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |Organon & Co.|Last Updated: May 23, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment2,251

FDA Designations

No designations recorded

Clinical trial landscape

Mometasone furoate/formoterol combination · 2 trials · 1 indication

Phase 3 2
NCT00383435Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED1,055 Analytics
NCT00383721Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)(COMPLETED)Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED1,196 Analytics
PHASE3COMPLETED
Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics
PHASE3COMPLETED
Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)(COMPLETED)
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)
Baseline to Endpoint (13 weeks)

FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.

Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1
Baseline to Endpoint (13 weeks)

Endpoint was the last post-baseline non-missing result through Week 13 carried forward.

Secondary Endpoints

Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score
Baseline to Endpoint (26 weeks)
Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)
Baseline to Endpoint (26 weeks)
Number of Participants With Partly Stable COPD
Endpoint (26 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MF/F MDI 400/10 mcg BIDEXPERIMENTAL -
MF/F MDI 200/10 mcg BIDEXPERIMENTAL -
MF MDI 400 mcg BIDEXPERIMENTAL -
Formoterol MDI 10 mcg BIDACTIVE_COMPARATOR -
Placebo MDI BIDPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Mometasone furoate/formoterol (MF/F) combinationDRUGMF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
Mometasone furoate MDI (MF MDI)DRUGMF 400 mcg via metered dose inhaler twice daily for 52 weeks
Formoterol MDIDRUGFormoterol 10 mcg via metered dose inhaler twice a day for 52 weeks
PlaceboDRUGPlacebo MDI twice a day for 26 weeks
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Moderate to severe COPD based on prebronchodilator FEV1/forced vital capacity (FVC) ratio of \<=70%. * At Screening, postbronchodilator FEV1 must be \<=60% predicted normal \& \>=25% predicted normal. * COPD symptoms for \>=24 months. * Ex- or current smoker with smoking histo...

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Frequently asked questions about Mometasone furoate/formoterol combination

What is Mometasone Furoate used for?

Mometasone Furoate is a small molecule being developed for allergic rhinitis, asthma, seasonal allergic rhinitis, perennial allergic rhinitis, chronic obstructive pulmonary disease (COPD), and adenoids hypertrophy. It is administered as a nasal spray and is currently in Phase 3 clinical development for these ENT-related conditions.

Who makes Mometasone Furoate?

Mometasone Furoate is being developed by Organon & Co., a company traded on the New York Stock Exchange under the ticker symbol OGN. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy in treating allergic rhinitis and related respiratory conditions.

What phase is Mometasone Furoate in?

Mometasone Furoate is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Four Phase 3 trials have been completed, with a total enrollment of 2,251 participants, all of which were randomized, double-blind, and placebo-controlled.

What clinical trials is Mometasone Furoate in?

Mometasone Furoate has completed four Phase 3 trials: NCT00599027 in patients with allergic rhinitis and intermittent asthma, NCT00732381 and NCT00733005 in seasonal allergic rhinitis, and NCT03855228 evaluating the addition of loratadine in seasonal allergic rhinitis. All trials are completed with no active trials currently ongoing.

How does Mometasone Furoate work?

Mometasone Furoate is a corticosteroid that works by reducing inflammation in the nasal passages. It is administered as a nasal spray to relieve symptoms associated with allergic rhinitis, including nasal congestion. The drug targets inflammatory pathways to provide relief from allergy symptoms.