Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Formoterol DPI · 1 trial · 1 indication
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Treatment Period 1: Placebo MDI with spacer; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: F DPI |
| Sequence 2 | EXPERIMENTAL | Treatment Period 1: F DPI; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI with spacer |
| Sequence 3 | EXPERIMENTAL | Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: Placebo MDI with spacer; Treatment Period 4: MF/F MDI with spacer |
| Sequence 4 | EXPERIMENTAL | Treatment Period 1: Placebo MDI without spacer; Treatment Period 2: MF/F MDI with spacer; Treatment Period 3: F DPI; Treatment Period 4: MF/F MDI without spacer |
| Sequence 5 | EXPERIMENTAL | Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI without spacer |
| Sequence 6 | EXPERIMENTAL | Treatment Period 1: MF/F MDI with spacer; Treatment Period 2: Placebo MDI without spacer; Treatment Period 3: MF/F MDI without spacer; Treatment Period 4: F DPI |
| Name | Type | Description |
|---|---|---|
| Formoterol Fumarate DPI | DRUG | Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose |
| Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer | DRUG | Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer) |
| Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer | DRUG | Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer) |
| Placebo MDI with spacer | DRUG | Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer) |
| Placebo MDI without spacer | DRUG | Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer) |
| Mometasone Furoate DPI | DRUG | Two inhalations of MF DPI 100 mcg administered as a single dose once daily at night. Used as maintenance therapy during screening and in between single doses of study drug. |
Inclusion Criteria: * Must have a diagnosis of asthma of at least 6 months duration * Must have taken an Inhaled Corticosteroid (\[ICS\]; alone or in combination with a long-acting beta-2 Agonist \[LABA\]) for at least 3 months prior to the Screening Visit and must have been on a stable daily dose ...
Formoterol DPI is a small molecule being developed for the treatment of asthma. It is a dry powder inhaler formulation of formoterol, a bronchodilator. The drug is currently in Phase 2 clinical development and is being studied for its effects in patients with persistent asthma.
Formoterol DPI 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 drug's safety and efficacy in treating asthma.
Formoterol DPI is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for the treatment of asthma, and one Phase 2 trial has been completed.
Formoterol DPI has one completed Phase 2 clinical trial, identified as NCT01258803. This study, titled "A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)," enrolled 92 participants aged 5 years and older with asthma.
Formoterol DPI is a dry powder inhaler formulation of formoterol fumarate, a bronchodilator. The clinical trial NCT01258803 studied formoterol fumarate in combination with mometasone furoate metered dose inhaler. The drug is being developed for the treatment of asthma.