Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LAS100977 0.313 μg · 1 trial · 1 indication
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...
LAS100977 0.313 μg is an investigational small molecule being developed for the treatment of asthma. It is currently in Phase 2 clinical development and has been studied in a completed clinical trial involving patients with asthma.
LAS100977 0.313 μg is a small molecule, but its specific molecular target has not been disclosed. The drug is being investigated for its efficacy, safety, and tolerability in patients with asthma.
LAS100977 0.313 μg is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN.
LAS100977 0.313 μg is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
LAS100977 0.313 μg was studied in a completed Phase 2 clinical trial with the identifier NCT01425801. This was a single-dose, randomized, double-blind, placebo-controlled study that enrolled 62 patients with asthma in Germany and the United Kingdom.