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 of two bronchodilators being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is a small molecule therapy in Phase 2 clinical development, intended to improve lung function in patients with COPD.
Aclidinium 400 μg/ Formoterol 12 μg combines aclidinium bromide, a long-acting muscarinic antagonist, with formoterol fumarate, a long-acting beta-agonist. These two bronchodilators work through different mechanisms to relax airway muscles and improve airflow in patients with COPD.
Aclidinium 400 μg/ Formoterol 12 μg is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of this combination therapy for COPD.
Aclidinium 400 μg/ Formoterol 12 μg is currently in Phase 2 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The Phase 2 trial has been completed, and the results will inform whether the drug advances to later-stage clinical trials.
Aclidinium 400 μg/ Formoterol 12 μg has one completed Phase 2 clinical trial registered under NCT01049360. This randomized, double-blind, placebo-controlled study enrolled 128 participants with Chronic Obstructive Pulmonary Disease in the United States. The trial compared two fixed-dose combinations of aclidinium bromide with formoterol fumarate against each monotherapy and placebo.
Aclidinium 400 μg/ Formoterol 12 μg is a fixed-dose combination product that contains two active ingredients: aclidinium bromide and formoterol fumarate. While the combination is distinct from the individual monotherapies, it delivers both medications in a single inhaler for the treatment of COPD.