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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01425814 | Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population | PHASE2 | COMPLETED | 87 | — | — | Aug 1, 2011 | Mar 1, 2012 | Apr 10, 2017 | 8 | Germany |
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
| Arm | Type | Description |
|---|---|---|
| Arm #2 | EXPERIMENTAL | Single dose, double blind treatment period |
| Arm #3 | EXPERIMENTAL | Single dose, double blind treatment period |
| Arm #4 | EXPERIMENTAL | Single dose, double blind treatment period |
| Arm #5 | ACTIVE_COMPARATOR | Single dose, double blind treatment period |
| Arm #6 | PLACEBO_COMPARATOR | Single dose, double blind treatment period |
| Arm #1 | EXPERIMENTAL | Single dose, double blind treatment period |
| Name | Type | Description |
|---|---|---|
| LAS100977 | DRUG | Dry powder inhalation,Once daily, single dose |
| Reference | DRUG | Dry powder inhalation (capsule),single dose |
| Placebo | DRUG | Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose |
Inclusion Criteria: 1. Males and non-pregnant, non-lactating females aged 40 or older. 2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction. 3. Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less ...