Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aclidinium bromide 200 μg · 2 trials · 2 indications
Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.
| Arm | Type | Description |
|---|---|---|
| Aclidinium Bromide 200 µg | EXPERIMENTAL | aclidinium bromide, inhaled, 52 weeks of treatment |
| Aclidinium Bromide 400 µg | EXPERIMENTAL | aclidinium bromide, inhaled, 52 weeks of treatment |
| Aclidinium bromide 200 μg bid | EXPERIMENTAL | Aclidinium bromide 200 μg twice-daily via inhalation |
| Aclidininum bromide 400 μg bid | EXPERIMENTAL | Aclidinium bromide 400 μg twice-daily via inhalation |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Aclidinium Bromide 200 µg | DRUG | aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment |
| Aclidinium Bromide 400 µg | DRUG | aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment |
| Aclidinium bromide 200 μg bid | DRUG | Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks |
| Aclidinium bromide 400 μg bid | DRUG | Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks |
| Placebo | DRUG | Placebo twice-daily by inhalation for 24 weeks |
Inclusion Criteria: * A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC \< 70%, and postbronchodilator FEV1 ≥ 30% and \< 80% predicted * Current or former cigarette smokers Exc...
Aclidinium bromide 200 μg is an inhaled small molecule developed for the treatment of chronic obstructive pulmonary disease (COPD). It is studied in patients with moderate to severe COPD, with dosing given twice daily. The clinical program enrolled adults aged 40 years and older in placebo-controlled Phase 3 trials.
Aclidinium bromide 200 μg acts as an antagonist at CHRM3, the muscarinic acetylcholine receptor subtype M3. By blocking this receptor in the airways, it reduces cholinergic bronchoconstriction. This makes it a long-acting muscarinic antagonist, a bronchodilator class used to relieve airflow obstruction in COPD.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of aclidinium bromide 200 μg. The company sponsored the Phase 3 clinical program evaluating the 200 μg twice-daily dose in chronic obstructive pulmonary disease.
Aclidinium bromide 200 μg has been evaluated in Phase 3 clinical development. Two Phase 3 trials are recorded, both completed, with no active trials remaining. The program studied the 200 μg twice-daily dose in chronic obstructive pulmonary disease.
Aclidinium bromide 200 μg was studied in two completed Phase 3 trials: NCT01044459, a long-term safety, tolerability and efficacy study in moderate to severe COPD with 605 patients, and NCT01001494, an efficacy and safety study comparing two dose levels versus placebo with 828 patients. Both were randomized, double-blind and placebo-controlled.