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MF/F MDI 100

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

MF/F MDI 100 clinical trials

MF/F MDI 100 · 1 trial · 1 indication

Phase 3 1
NCT00817817A Study to Determine the Efficacy and Safety of Two Mometasone Dry Powder Inhalers in the Treatment of Asthma (Study P02524)Asthma
COMPLETED93 Analytics
PHASE3COMPLETED
A Study to Determine the Efficacy and Safety of Two Mometasone Dry Powder Inhalers in the Treatment of Asthma (Study P02524)
AsthmaUnlock trial analytics

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 to 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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Frequently asked questions about MF/F MDI 100

What is MF/F MDI 100 used for?

MF/F MDI 100 is an investigational inhaled therapy being studied for the treatment of asthma in adults. It is delivered as a metered dose inhaler and was evaluated in a Phase 3 clinical trial in patients with asthma. It is not described as approved for any use.

Who is developing MF/F MDI 100?

MF/F MDI 100 is being developed by Organon & Co., which trades under the ticker OGN. Organon is the sponsor of the clinical program evaluating this inhaled asthma therapy.

What phase is MF/F MDI 100 in?

MF/F MDI 100 is in Phase 3 development. Its single registered trial, NCT00817817, is listed as a Phase 3 study and has completed. The drug remains investigational and is not described as FDA approved.

What clinical trials is MF/F MDI 100 in?

MF/F MDI 100 has been studied in one registered trial, NCT00817817, titled a study to determine the efficacy and safety of two mometasone dry powder inhalers in the treatment of asthma. That Phase 3 trial is completed, enrolled 93 participants, and included adults aged 18 years and older.

How was the MF/F MDI 100 asthma trial designed?

The Phase 3 trial NCT00817817 was a controlled study of MF/F MDI 100 in asthma, with 93 participants randomized. It was not double blind, enrolled adults 18 years and older of any sex, and did not use biomarker-based patient selection. The study is completed.