Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mometasone furoate/formoterol 100 · 3 trials · 2 indications
The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F versus MF. Standard deviation was pooled.
| Arm | Type | Description |
|---|---|---|
| MF/F MDI 200/10 mcg BID | EXPERIMENTAL | Mometasone furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily. |
| F/SC DPI 250/50 mcg BID | ACTIVE_COMPARATOR | Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID |
| MF/F MDI 400/10 mcg BID | EXPERIMENTAL | Mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period |
| MF MDI 400 mcg BID | ACTIVE_COMPARATOR | Mometasone Furoate 400 mcg taken twice daily Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period |
| MF/F MDI 100/10 mcg | EXPERIMENTAL | - |
| MF/F MDI 200/10 mcg | EXPERIMENTAL | - |
| MF/F MDI 400/10 mcg | EXPERIMENTAL | - |
| MF DPI 200 mcg | EXPERIMENTAL | - |
| MF MDI 200 mcg | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Mometasone furoate/formoterol (MF/F) MDI | DRUG | MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks. |
| Fluticasone propionate/salmeterol (F/SC) DPI | DRUG | Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks. |
| Mometasone furoate/formoterol (MF/F) combination | DRUG | MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks |
| Mometasone furoate MDI (MF MDI) | DRUG | MF 400 mcg via metered dose inhaler twice daily for 12 weeks |
| mometasone furoate/formoterol 100/10 mcg | DRUG | mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days |
| mometasone furoate/formoterol 200/10 mcg | DRUG | mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days |
| mometasone furoate/formoterol 400/10 mcg | DRUG | mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days |
| MF DPI 200 mcg | DRUG | MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days |
| MF MDI 200 mcg | DRUG | MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days |
| Placebo | DRUG | MF/F MDI placebo twice daily (BID) (2 inhalations) |
Inclusion Criteria: * Participants must have a diagnosis of asthma for at least 12 months' duration. * A participant must have been using a medium daily dose of inhaled glucocorticosteroids (alone or in combination with long-acting beta 2-agonist \[LABA\]) for at least 12 weeks and must have been o...
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.
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.
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.
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.
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.