Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aclidinium Bromide/Formoterol · 5 trials · 1 indication
TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)
Change From Baseline (Visit 2 of lead-in Study NCT00891462, \[LAS-MD-33\]) to Week 52 (Week 64 From Start of NCT00891462, \[LAS-MD-33\]) in Morning Predose (Trough) FEV1
Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day |
| 2 | ACTIVE_COMPARATOR | Inhaled formoterol fumarate 12 μg, twice per day |
| 3 | ACTIVE_COMPARATOR | Aclidinium monotherapy 400 μg |
| 4 | ACTIVE_COMPARATOR | Formoterol monotherapy 12 μg |
| 5 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Aclidinium Bromide/Formoterol Fumarate | DRUG | Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day |
| Formoterol Fumarate | DRUG | Inhaled formoterol fumarate 12 μg, twice per day |
| Aclidinium Bromide | DRUG | Inhaled Aclidinium 400 μg, twice per day |
| Placebo | DRUG | Inhaled dose-matched placebo, twice per day |
Inclusion Criteria: * Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years * A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway ob...
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.