Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aclidinium/formoterol 400/12μg · 1 trial · 1 indication
The standard deviation of the measure is expressed as the coefficient of variation (%)
The standard deviation of the measure is expressed as the coefficient of variation (%)
The standard deviation of the measure is expressed as the coefficient of variation (%)
| Arm | Type | Description |
|---|---|---|
| Aclidinium/formoterol 400/12μg FDC | EXPERIMENTAL | Aclidinium/formoterol 400/12μg fixed-dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler |
| Formoterol | ACTIVE_COMPARATOR | Formoterol 12μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer® |
| Name | Type | Description |
|---|---|---|
| Aclidinium/formoterol 400/12μg | DRUG | Aclidinium/formoterol 400/12μg fixed dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler |
| Formoterol | DRUG | Formoterol 12 μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer® |
Inclusion Criteria: * Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years * A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway ob...
Aclidinium/formoterol 400/12μg is being developed for the treatment of chronic obstructive pulmonary disease (COPD). It is a fixed dose combination small molecule therapeutic in the respiratory area, studied in patients with moderate to severe COPD. It is investigational and has not been approved for commercial use.
Aclidinium/formoterol 400/12μg targets CHRM3, the M3 muscarinic acetylcholine receptor, as an antagonist. The fixed dose combination pairs aclidinium, a long-acting muscarinic antagonist, with formoterol, a long-acting beta-2 agonist, in a single inhaled formulation intended to produce bronchodilation in COPD.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of aclidinium/formoterol 400/12μg. The company is the sponsor behind the clinical program evaluating this fixed dose combination in chronic obstructive pulmonary disease.
Aclidinium/formoterol 400/12μg is in Phase 2 clinical development. It is an investigational product and is not FDA approved. The Phase 2 program has completed, and no trials of this combination are currently listed as active.
Aclidinium/formoterol 400/12μg has been studied in one completed Phase 2 trial, NCT01551888. That randomized, double-blind, active-controlled study enrolled 24 patients with moderate to severe COPD in the United States, with participants aged 40 years and older, and assessed pharmacokinetics, safety, and tolerability.