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Also known as Formoterol Fumarate DPI
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 ...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Formoterol DPI is an inhaled dry powder formulation of formoterol, a long-acting bronchodilator being studied for the treatment of asthma. It is designed to be delivered directly to the airways to help relax the smooth muscle surrounding them and improve airflow in patients with persistent asthma.
Formoterol DPI works as an agonist at the beta-2 adrenergic receptor, also known as ADRB2. By activating this receptor on airway smooth muscle cells, it triggers bronchodilation, which helps open the airways and ease breathing in people with asthma.
Formoterol DPI is being developed by Organon & Co., which trades on the New York Stock Exchange under the ticker OGN. Organon is a global healthcare company focused on women's health and other therapeutic areas, including respiratory medicine.
Formoterol DPI is in Phase 2 clinical development for asthma. It is an investigational product and has not been approved by the FDA for this indication. The Phase 2 program has completed one trial, and no active trials are currently listed.
Formoterol DPI has been studied in one completed Phase 2 trial, NCT01258803. This randomized, controlled study evaluated the bronchodilator effect of formoterol fumarate used in combination with mometasone furoate metered dose inhaler in children aged 5 years and older with persistent asthma, enrolling 92 participants.
Yes, Formoterol DPI is also known as Formoterol Fumarate DPI. The two names refer to the same dry powder inhaler product, with formoterol fumarate being the specific salt form of the active ingredient used in the formulation.