Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aclidinium Bromide · 1 trial · 1 indication
Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.
| Arm | Type | Description |
|---|---|---|
| Aclidinium | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Aclidinium Bromide | DRUG | Aclidinium Bromide, 200μg. Once daily oral inhalation. |
| Placebo | DRUG | Dose matched placebo, once daily oral inhalation. |
Inclusion Criteria: * A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 \>=30% and \< 80% predicted and FEV1/FVC\<70% predicted * Current or former cigarette smoker * Functional Residual Capacity (FRC) measured by body plethysmography \>= 120% of predicted value * Ba...
Aclidinium Bromide is used for the treatment of moderate to severe Chronic Obstructive Pulmonary Disease (COPD). It is a small molecule being developed by AstraZeneca PLC for this respiratory condition.
Aclidinium Bromide is being developed by AstraZeneca PLC, a company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the drug's efficacy and safety in patients with COPD.
Aclidinium Bromide is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trials are designed to assess its efficacy and safety in treating moderate to severe COPD.
Aclidinium Bromide has been studied in several Phase 3 clinical trials, including NCT00891462, NCT00970268, NCT01045161, and NCT01437540. These trials enrolled patients with moderate to severe COPD and have all been completed. The studies were randomized, double-blind, and placebo-controlled.
Aclidinium Bromide has been studied in combination with formoterol fumarate. One clinical trial, NCT01437540, compared the safety and tolerability of aclidinium bromide/formoterol fumarate against formoterol fumarate alone in patients with moderate to severe COPD.