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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02059434 | Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD | PHASE1 | COMPLETED | 55 | — | — | Sep 1, 2013 | Oct 6, 2014 | Jun 21, 2019 | 2 | United Kingdom |
Adverse events (AEs) are any unfavorable and unintended medical occurrence during the subject's participation in the study (including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, an ECG abnormality, a 12-lead 24-hour ECG-Holter abnormality, a blood pressure abnormal value, paradoxal bronchospasm or an abnormal finding in the physical examination) and will be coded using the current Medical Dictionary for Regulatory Activities (MedDRA).
Trough is defined as the mean of the FEV1 values obtained at 23 hours and at 24 hours after morning investigational product administration.
| Arm | Type | Description |
|---|---|---|
| LAS190792 Dose 1 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 2 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 3 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 4 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 5 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 6 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| Placebo (Part 1) | PLACEBO_COMPARATOR | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 1 (Part 2) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 2 (Part 2) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| Tiotropium 18 μg | ACTIVE_COMPARATOR | Single dose, oral inhalation by HandiHaler® single-dose DPI |
| Indacaterol 150 μg | ACTIVE_COMPARATOR | Single dose, oral inhalation by Breezhaler® single-dose DPI |
| Placebo (Part 2) | PLACEBO_COMPARATOR | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| Name | Type | Description |
|---|---|---|
| LAS190792 Dose 1 | DRUG | - |
| LAS190792 Dose 2 | DRUG | - |
| LAS190792 Dose 3 | DRUG | - |
| LAS190792 Dose 4 | DRUG | - |
| LAS190792 Dose 5 | DRUG | - |
| LAS190792 Dose 6 | DRUG | - |
| LAS190792 Dose 1 (Part 2) | DRUG | - |
| LAS190792 Dose 2 (Part 2) | DRUG | - |
| Tiotropium 18 μg | DRUG | - |
| Indacaterol 150 μg | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria (PART 1): * Adult male subjects aged 18 to 70 years * Body mass index (BMI) 18.5 to 30 kg/m2 at screening * Clinical diagnosis of mild persistent asthma (according to GINA guidelines) for at least 6 months prior to screening * Ability to change current asthma therapy, to disconti...