Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aclidinium 200 μg/ formoterol 12 μg · 1 trial · 1 indication
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose
| Arm | Type | Description |
|---|---|---|
| Formoterol 12 μg | ACTIVE_COMPARATOR | Formoterol fumarate 12 μg twice daily |
| Placebo | PLACEBO_COMPARATOR | Placebo twice daily |
| Aclidinium 200 μg / formoterol 12 μg | EXPERIMENTAL | Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily |
| Aclidinium 200 μg / formoterol 6 μg | EXPERIMENTAL | Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily |
| Aclidinium 200 μg | EXPERIMENTAL | Aclidinium bromide 200 μg twice daily |
| Name | Type | Description |
|---|---|---|
| Aclidinium 200 μg / formoterol 12 μg | DRUG | Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily |
| Placebo | DRUG | Placebo control twice daily |
| Formoterol 12 μg | DRUG | Formoterol fumarate 12 μg twice daily |
| Aclidinium 200 μg | DRUG | Aclidinium bromide 200 μg twice daily |
| Aclidinium 200 μg / Formoterol 6 μg | DRUG | Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily |
Inclusion Criteria: 1. Adult male or non-pregnant, non-lactating female aged between 40 and 80 years old, both inclusive. 2. Patient with a clinical diagnosis of stable moderate to severe COPD according to the GOLD classification 3. Current, or ex-cigarette smoker with a smoking history of at least...
Aclidinium 200 μg/formoterol 12 μg is being studied for the treatment of chronic obstructive pulmonary disease (COPD). It is a fixed-dose combination of aclidinium bromide and formoterol fumarate delivered as a small molecule therapy. The combination is designed to provide bronchodilation through two different mechanisms in patients with COPD.
Aclidinium 200 μg/formoterol 12 μg targets the CHRM3 receptor as an antagonist. Aclidinium blocks muscarinic M3 receptors to reduce bronchoconstriction, while formoterol, a long-acting beta2-agonist, relaxes airway smooth muscle. Together they aim to improve lung function in COPD.
AstraZeneca PLC (ticker: AZN) is developing aclidinium 200 μg/formoterol 12 μg. The company is responsible for the clinical development of this fixed-dose combination for COPD.
Aclidinium 200 μg/formoterol 12 μg is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed.
Aclidinium 200 μg/formoterol 12 μg has been evaluated in one completed Phase 2 trial, NCT01078623, titled "Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate." The trial enrolled 176 participants with COPD in Czechia and Romania and was randomized, double-blind, and placebo-controlled.