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 an investigational fixed-dose combination of two small molecules being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Aclidinium 200 μg/formoterol 12 μg 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 COPD.
Aclidinium 200 μg/formoterol 12 μg is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the drug remains under investigation for Chronic Obstructive Pulmonary Disease.
Aclidinium 200 μg/formoterol 12 μg has one completed Phase 2 clinical trial registered as NCT01078623, titled 'Efficacy and Safety of Two Fixed Dose Combinations of Aclidinium Bromide With Formoterol Fumarate.' The trial enrolled 176 participants with Chronic Obstructive Pulmonary Disease in Czechia and Romania.
Yes, Aclidinium 200 μg/formoterol 12 μg is a fixed-dose combination of aclidinium bromide and formoterol fumarate. The clinical trial NCT01078623 evaluates this combination for the treatment of Chronic Obstructive Pulmonary Disease, and the drug is being developed by AstraZeneca PLC.