Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MF MDI · 1 trial · 1 indication
This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 60 minutes post-dose (at 0, 5, 15, 30 and 60 minutes) and averaged across study visits in the Treatment Period (Day 1, Week 1, Week 4, Week 8 and Week 12) compared to Baseline. Baseline was the average of % predicted FEV1 values at 30 min and 0 min pre-dose. At each visit, the area under the curve is calculated over the post-dose timepoints. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC.
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.
| Arm | Type | Description |
|---|---|---|
| MF/F MDI 100/10 mcg BID | EXPERIMENTAL | Eligible participants will be assigned randomly to receive double-blinded MF/F MDI 100/10 mcg BID for 24 weeks. |
| MF MDI 100 mcg BID | ACTIVE_COMPARATOR | Eligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| MF MDI 100 mcg BID (Open Label) | DRUG | Eligible participants will receive open-label MF MDI 100 mcg BID during a 2-week run-in period. |
| MF/F MDI 100/10 mcg BID | DRUG | After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF/F MDI 100/10 mcg BID. |
| MF MDI 100 mcg BID | DRUG | After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF MDI 100 mcg BID. |
| Albuterol/Salbutamol PRN | DRUG | Participants may use study-provided short-acting beta agonist (SABA), albuterol/salbutamol, as needed (PRN) for the relief of asthma symptoms. |
| Prednisone/Prednisolone | DRUG | Participants may use a systemic corticosteroid (prednisone/prednisolone) for acute asthma worsening per investigator discretion. |
Inclusion Criteria: * Has a diagnosis of asthma of ≥ 6-months duration according to the Global Initiative for Asthma (GINA) guidelines * Has asthma that is adequately controlled on a stable dose of inhaled corticosteroid (ICS) combined with long-acting beta-agonist (LABA) ≥ 4 weeks * Is able to dem...
MF MDI is an investigational small molecule being developed for the treatment of asthma. It is a combination therapy being studied in pediatric patients with persistent asthma. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
MF MDI is a combination of mometasone furoate, a corticosteroid, and formoterol fumarate, a long-acting beta-agonist. The mometasone furoate component targets inflammation in the airways, while formoterol fumarate targets bronchoconstriction to help relax airway muscles. This dual mechanism is designed to address asthma symptoms.
MF MDI 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 safety and efficacy of this investigational asthma treatment.
MF MDI is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies. The Phase 3 trial has been completed, and the drug is being evaluated for long-term safety and efficacy in children with persistent asthma.
MF MDI has one completed Phase 3 clinical trial registered under NCT02741271. This study evaluated the efficacy and long-term safety of mometasone furoate in combination with formoterol fumarate versus mometasone furoate alone in children aged 5 to 11 years with persistent asthma. The trial enrolled 181 participants.
MF MDI is the drug being studied in the clinical trial identified as MK-0887A-087. The trial title references the combination of mometasone furoate and formoterol fumarate, which is the MF MDI formulation. The NCT number for this trial is NCT02741271.