Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aclidinium 400 μg/ Formoterol 12 μg · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Aclidinium 400 μg / Formoterol 12 μg | EXPERIMENTAL | Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) |
| Aclidinium 400 μg / formoterol 6 μg | EXPERIMENTAL | Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) |
| Aclidinium 400 μg | EXPERIMENTAL | Aclidinium bromide 400 μg administered twice-daily (BID) |
| Formoterol 12 μg | ACTIVE_COMPARATOR | Formoterol fumarate 12 μg twice-daily |
| Placebo | PLACEBO_COMPARATOR | Placebo twice-daily |
| Name | Type | Description |
|---|---|---|
| Aclidinium 400 μg / Formoterol 12 μg | DRUG | Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods. |
| Aclidinium 400 μg / Formoterol 6 μg | DRUG | Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID) for a 14 day period within four different treatment periods. |
| Aclidinium 400 μg | DRUG | Aclidinium bromide 400 μg administered twice-daily (BID) for a 14 day period within four different treatment periods. |
| Formoterol 12 μg | DRUG | Formoterol fumarate 12 μg twice-daily for a 14 day period within four different treatment periods. |
| Placebo | DRUG | Placebo twice-daily delivered by inhalation for a 14 day period within four different treatment periods. |
Inclusion Criteria: * Understand the study procedures and be willing to participate in the study as indicated by signing the ICF and HIPAA form * Be male or female aged 40 to 80 years, inclusive * Have a diagnosis of stable, moderate to severe COPD (stages II and III) as defined by guidelines of th...
Aclidinium 400 μg/ Formoterol 12 μg is an investigational fixed-dose combination being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It combines aclidinium bromide and formoterol fumarate in a single inhaled formulation. It is not approved and remains in clinical development.
Aclidinium 400 μg/ Formoterol 12 μg targets CHRM3, the M3 muscarinic acetylcholine receptor, where aclidinium acts as an antagonist. The formoterol component is a long-acting beta2-agonist. Together the two agents are designed to produce bronchodilation through complementary mechanisms in patients with COPD.
AstraZeneca PLC (ticker AZN) is the developer of Aclidinium 400 μg/ Formoterol 12 μg. The company is responsible for the clinical development of this fixed-dose combination for COPD.
Aclidinium 400 μg/ Formoterol 12 μg is in Phase 2 development. It is an investigational product and has not been approved by the FDA. The Phase 2 program has been completed, with no active trials currently listed.
Aclidinium 400 μg/ Formoterol 12 μg has been evaluated in one completed Phase 2 trial, NCT01049360. The study was a randomized, double-blind, placebo-controlled trial comparing two fixed-dose combinations of aclidinium bromide with formoterol fumarate against aclidinium bromide, formoterol fumarate, and placebo in 128 patients with COPD in the United States.