Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Formatris 24µg · 1 trial · 1 indication
The primary variable is the methacholine PC20 after inhalation of study medication; the PC20 is the concentration of methacholine that - despite protection by study medication - causes a 20% fall in FEV1 compared to the pre-methacholine (post-saline) level of the given study day.
| Arm | Type | Description |
|---|---|---|
| 24 µg Formoterol Novolizer | EXPERIMENTAL | 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| 12µg Formoterol Novolizer | EXPERIMENTAL | 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| 24 µg Formoterol Aerolizer | ACTIVE_COMPARATOR | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2 |
| 12µg Formoterol Aerolizer | ACTIVE_COMPARATOR | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2 |
| Name | Type | Description |
|---|---|---|
| Formatris 24µg | DRUG | 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| Formatris 12µg | DRUG | 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| Foradil P 24µg | DRUG | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2 |
| Foradil P 12µg | DRUG | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2 |
Inclusion Criteria: 1. Male or female patients aged from 18 to 60 years (inclusive). 2. Patients with asthma indicated by * history of asthma symptoms and * airway hyperresponsiveness to methacholine with a provocation concentration of methacholine that cause a 20% decrease in FEV1 (PC20) ≤8...
Formatris 24µg is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with asthma to evaluate its efficacy and safety.
Formatris 24µg is being developed by Viatris Inc. (NASDAQ: VTRS), a global healthcare company. The drug is currently in Phase 2 clinical development for the treatment of asthma.
Formatris 24µg is in Phase 2 clinical development. It is an investigational drug and has not been approved for use. One Phase 2 clinical trial has been completed, and the drug is being studied for the treatment of asthma.
Formatris 24µg has been studied in one completed Phase 2 clinical trial, NCT01256086, titled "Relative Potency of Formoterol Novolizer® 12 µg Compared to Formoterol Aerolizer® 12 µg." The trial enrolled 44 participants with asthma in the United States and was randomized, double-blind, and active-controlled.
Formatris 24µg is a formulation of formoterol, a bronchodilator used in asthma treatment. The completed clinical trial compared the relative potency of formoterol delivered via different inhaler devices. The drug is being developed by Viatris Inc. for asthma.