Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01437540 | Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease | PHASE3 | COMPLETED | 590 | — | — | Sep 19, 2011 | Apr 30, 2013 | May 11, 2017 | 137 | United States |
| NCT01437397 | Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | PHASE3 | COMPLETED | 1,692 | — | — | Sep 1, 2011 | Feb 1, 2013 | Mar 23, 2017 | 222 | United States, Australia +2 |
| NCT00970268 | Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36) | PHASE3 | COMPLETED | 291 | — | — | Aug 1, 2009 | Oct 1, 2010 | Jan 6, 2017 | 83 | United States, Canada |
| NCT00891462 | Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33) | PHASE3 | COMPLETED | 561 | — | — | Apr 1, 2009 | Nov 1, 2009 | Jan 6, 2017 | 112 | United States, Canada |
| NCT01045161 | Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38) | PHASE3 | COMPLETED | 544 | — | — | Mar 1, 2009 | Jun 1, 2011 | Jan 23, 2017 | 112 | United States, Canada |
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...