Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Indacaterol 400 μg · 1 trial · 1 indication
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Baseline and at the end of each treatment period. The analysis included period baseline FEV1 as covariate.
| Arm | Type | Description |
|---|---|---|
| Indacaterol (ind) maleate-placebo-ind xinafoate-ind acetate | EXPERIMENTAL | In treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Indacaterol (ind) xinafoate-ind maleate-ind acetate-placebo | EXPERIMENTAL | In treatment period 1, patients received indacaterol xinafoate 400 μg; in treatment period 2, patients received indacaterol maleate 400 μg; in treatment period 3, patients received indacaterol acetate 400 μg; and in treatment period 4, patients received placebo to indacaterol 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Indacaterol (ind) acetate-ind xinafoate-placebo-ind maleate | EXPERIMENTAL | In treatment period 1, patients received indacaterol acetate 400 μg; in treatment period 2, patients received indacaterol xinafoate 400 μg; in treatment period 3, patients received placebo to indacaterol; and in treatment period 4, patients received indacaterol maleate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Placebo-indacaterol (ind) acetate-ind maleate-ind xinafoate | EXPERIMENTAL | In treatment period 1, patients received placebo to indacaterol; in treatment period 2, patients received indacaterol acetate 400 μg; in treatment period 3, patients received indacaterol maleate 400 μg; and in treatment period 4, patients received indacaterol xinafoate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Name | Type | Description |
|---|---|---|
| Indacaterol maleate 400 μg | DRUG | Indacaterol maleate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. |
| Indacaterol acetate 400 μg | DRUG | Indacaterol acetate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. |
| Indacaterol xinafoate 400 μg | DRUG | Indacaterol xinafoate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. |
| Placebo to indacaterol | DRUG | Placebo to indacaterol was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. |
Inclusion Criteria: * Non-smoker male and female adult patients aged 18-75 years inclusive, who have signed an informed consent form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to screening. * Patients with asthma, receiving daily treatme...
Indacaterol 400 μg is an investigational small molecule being developed for the treatment of asthma. It is a long-acting bronchodilator intended to improve lung function and control symptoms in patients with asthma. The drug is currently in clinical development and has not been approved by regulatory authorities.
Indacaterol 400 μg targets beta-2 adrenergic receptors in the airways. By binding to these receptors, it causes relaxation of bronchial smooth muscle, leading to bronchodilation. This mechanism helps to relieve bronchoconstriction and improve airflow in patients with asthma, although the drug remains investigational and is not yet approved.
Indacaterol 400 μg is developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the efficacy, safety, and pharmacokinetics of this drug in patients with asthma.
Indacaterol 400 μg is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for its safety and efficacy in patients with asthma, and further clinical trials are needed before it can be considered for regulatory approval.
Indacaterol 400 μg has been studied in one completed Phase 2 clinical trial, identified as NCT00927901. This trial, titled 'Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma,' enrolled 30 participants across France, Germany, and Italy. The study was randomized, double-blind, and controlled, and it has been completed.
Indacaterol 400 μg is a specific dose formulation of the drug indacaterol, which is a long-acting beta-2 adrenergic agonist. While indacaterol is available in other formulations and doses for conditions like COPD, the 400 μg dose is being investigated specifically for asthma. This dose is not yet approved and remains under clinical investigation.