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75 µg indacaterol · 1 trial · 1 indication
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 ...
75 µg indacaterol is an investigational small molecule being studied for the treatment of asthma. It is a low-dose formulation of indacaterol, a bronchodilator, and is being evaluated for its effects in patients with asthma. The drug is currently in Phase 2 clinical development.
75 µg indacaterol is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of asthma.
75 µg indacaterol is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of asthma, and a Phase 2 clinical trial has been completed to evaluate its effects.
75 µg indacaterol has been studied in one completed Phase 2 clinical trial with the identifier NCT01484197. This trial, titled 'A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device,' enrolled 36 participants with asthma and was conducted in Germany and the United Kingdom.
75 µg indacaterol refers to a specific low-dose formulation of indacaterol, which is being studied as indacaterol maleate in clinical trials. The Phase 2 trial NCT01484197 evaluates indacaterol maleate as a new formulation in the Concept 1 device, and the 75 µg dose is the subject of this investigation.