Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aclidinium bromide 100 μg · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Aclidinium bromide 100 μg bid | EXPERIMENTAL | Aclidininum bromide 100 μg twice daily by inhalation |
| Aclidininum bromide 200 μg bid | EXPERIMENTAL | Aclidininum bromide 200 μg twice daily by inhalation |
| Aclidininum bromide 400 μg bid | EXPERIMENTAL | Aclidininum bromide 400 μg twice daily by inhalation |
| Placebo | PLACEBO_COMPARATOR | Placebo twice-daily by inhalation |
| Formoterol 12 μg bid | ACTIVE_COMPARATOR | Formoterol 12 μg twice daily by inhalation |
| Name | Type | Description |
|---|---|---|
| Aclidinium bromide 100 μg bid | DRUG | Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
| Aclidinium bromide 200 μg bid | DRUG | Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
| Aclidininum bromide 400 μg bid | DRUG | Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
| Placebo | DRUG | Placebo via inhalation in the morning and evening for 7 days |
| Formoterol 12 μg bid | DRUG | Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days |
Inclusion Criteria: 1. Males and non-pregnant, non-lactating females aged ≥ 40. 2. Patients with a clinical diagnosis of stable moderate to severe COPD, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines: (http://www.goldcopd.com) and stable airway obstruction...
Aclidinium bromide 100 μg is an investigational inhaled small molecule being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is being developed by AstraZeneca PLC (ticker AZN). The 100 μg dose refers to a specific strength evaluated in clinical testing rather than an approved commercial product.
Aclidinium bromide 100 μg is an antagonist of CHRM3, the M3 muscarinic acetylcholine receptor. By blocking this receptor in the airways, the drug is designed to reduce cholinergic bronchoconstriction. This antagonist mechanism is the basis for its evaluation as a bronchodilator approach in COPD.
Aclidinium bromide 100 μg is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor associated with the clinical program evaluating this dose in Chronic Obstructive Pulmonary Disease. The asset is a small molecule in the respiratory therapeutic area.
Aclidinium bromide 100 μg is in Phase 2 development. It is an investigational agent and is not approved for commercial use. The Phase 2 program in Chronic Obstructive Pulmonary Disease has completed, with no active trials currently listed for this dose.
Aclidinium bromide 100 μg has been studied in one completed Phase 2 trial, NCT01120093, titled Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator in Chronic Obstructive Pulmonary Disease (COPD) Patients. The randomized, double-blind, placebo-controlled trial enrolled 79 participants in Belgium and Germany.