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MF, MF

Phase 3

Asthma | Unknown | Respiratory |Organon & Co.|Last Updated: Aug 15, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment93
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00817817A Study to Determine the Efficacy and Safety of Two Mometasone Dry Powder Inhalers in the Treatment of Asthma (Study P02524)PHASE3 COMPLETED 93Oct 1, 2002May 1, 2003Aug 15, 2024 -
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Study Endpoints
Primary Endpoints
The assessment of efficacy will be done by spirometry, determining the difference in FEV1 and PEFR measured by spirometry on baseline, 7, 14, 28, 42 and 56 days after initiation of MF dry powder inhaler (DPI) therapy.
Baseline, 7, 14, 28, 42, and 56 days after initiation of MF DPI therapy.
To determine the number of puffs/day of rescue medication (Salbutamol).
Daily
Secondary Endpoints
To compare the PEFR daily measurements obtained by Peak flow Meter used by subjects at home.
Daily
To compare the daily scores for asthma symptoms and sleep quality.
Every morning
To compare the evaluation of response to therapy made by the investigator at each visit compared to the Baseline visit.
Visits 2 to 6.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTAL -
Group 2EXPERIMENTAL -
Interventions
NameTypeDescription
MFDEVICEOne evening dose of dry powder inhaled MF 400 μg (Multidose device).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Must be \>=18 years of age, of either gender \& of any race. * Must have had a diagnosis of asthma for at least 6 months, characterized by recurrent episode of wheezing, breathlessness, chest tightness \& coughing. * Baseline FEV1 must be \>=55% and \<=85% of predicted at the ...

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