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 an investigational fixed-dose combination of two small molecules, aclidinium and formoterol, being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Aclidinium/formoterol 400/12μg is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this combination therapy for patients with COPD.
Aclidinium/formoterol 400/12μg is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy in patients with Chronic Obstructive Pulmonary Disease (COPD).
Aclidinium/formoterol 400/12μg has one completed Phase 2 clinical trial, identified as NCT01551888. This study was a randomized, double-blind, active-controlled trial that evaluated the pharmacokinetics, safety, and tolerability of the fixed-dose combination compared to formoterol alone in patients with moderate to severe COPD.
Aclidinium/formoterol 400/12μg is a fixed-dose combination of two bronchodilators: aclidinium, a long-acting muscarinic antagonist, and formoterol, a long-acting beta-agonist. Together, they work to relax and widen the airways in the lungs, helping to improve breathing in patients with Chronic Obstructive Pulmonary Disease (COPD).