Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg
Mometasone Furoate Metered Dose Inhaler · 1 trial · 1 indication
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.
| Arm | Type | Description |
|---|---|---|
| MF MDI 50 mcg BID | EXPERIMENTAL | Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks. |
| MF MDI 100 mcg BID | EXPERIMENTAL | Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| MF MDI 200 mcg BID | EXPERIMENTAL | Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| MF DPI 100 mcg QD | ACTIVE_COMPARATOR | Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg | DRUG | MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks |
| Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg | DRUG | MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks |
| Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg | DRUG | MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks |
| Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg | DRUG | MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks |
| Placebo Metered Dose Inhaler (MDI) | DRUG | Placebo MDI, 2 puffs BID for 12 weeks |
| Placebo Dry Powder Inhaler (DPI) | DRUG | Placebo DPI, 1 puff QD for 12 weeks |
Inclusion Criteria: * Diagnosis of asthma of at least 6 months duration. * Using an Inhaled corticosteroid (ICS), either alone or in combination with a long-acting beta-2 agonist (LABA), for at least 12 weeks prior to the Screening Visit and must have been on a stable asthma regimen for at least 2 ...