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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01484197 | A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device | PHASE2 | COMPLETED | 36 | — | — | Nov 1, 2011 | May 1, 2012 | Apr 1, 2015 | 2 | Germany, United Kingdom |
Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
| Arm | Type | Description |
|---|---|---|
| 75 µg Indacaterol (LB) + Placebo (PoS) | EXPERIMENTAL | 75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. |
| 75 µg Indacaterol (PoS) + Placebo (LB) | EXPERIMENTAL | 75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| 37.5 µg Indacaterol (PoS) + Placebo (LB) | EXPERIMENTAL | 37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| Placebo (LB) and Placebo (PoS) | EXPERIMENTAL | Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| Name | Type | Description |
|---|---|---|
| 75 µg indacaterol maleate (LB) | DRUG | 75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| 75 µg indacaterol maleate (PoS) | DRUG | 75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. |
| 37.5 µg indacaterol maleate (PoS) | DRUG | 37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. |
| placebo to indacaterol (LB) | DRUG | Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| placebo to indacaterol (PoS) | DRUG | Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. |
Inclusion Criteria: * Male and female patients with asthma * Aged 18 or above * Patients using inhaled corticosteroid (with or without long acting beta agonist) * Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist Exclusion Criteria: * Asthma exacerbations in ...