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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01425801 | Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients. | PHASE2 | COMPLETED | 62 | — | — | Aug 1, 2011 | Feb 1, 2012 | May 8, 2018 | 9 | Germany, United Kingdom |
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). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. 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 were selected.
| Arm | Type | Description |
|---|---|---|
| LAS100977 0.625 μg | EXPERIMENTAL | Single-dose LAS100977 0.625 μg, during double-blind treatment period |
| LAS100977 1.25 μg | EXPERIMENTAL | Single-dose LAS100977 1.25 μg, during double-blind treatment period |
| LAS100977 2.5 μg | EXPERIMENTAL | Single-dose LAS100977 2.5 μg, during double-blind treatment period |
| Salbutamol | ACTIVE_COMPARATOR | Single-dose salbutamol 400 μg, during double-blind treatment period |
| Placebo | PLACEBO_COMPARATOR | Placebo to LAS100977, and placebo to salbutamol |
| LAS100977 0.313 μg | EXPERIMENTAL | Single-dose LAS100977 0.313 μg, during double-blind treatment period |
| Name | Type | Description |
|---|---|---|
| LAS100977 0.313 μg | DRUG | Dry powder inhalation, once-daily, single-dose |
| LAS100977 0.625 μg | DRUG | Dry powder inhalation, once-daily, single-dose |
| LAS100977 1.25 μg | DRUG | Dry powder inhalation, once-daily, single-dose |
| LAS100977 2.5 μg | DRUG | Dry powder inhalation, once-daily, single-dose |
| Salbutamol 400 μg | DRUG | Pressurized inhalation suspension, once-daily, single-dose |
| Salbutamol placebo | DRUG | Pressurized inhalation, once-daily |
| LAS100977 placebo | DRUG | Dry powder inhalation, once-daily |
Inclusion Criteria: 1. Adult male and female patients aged 18-70 years (both included). 2. Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening. 3. Screening FEV1 value of 60% \< FEV1 ≤ 85% of the predicted normal value. 4. FEV1...