Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Indacaterol 75 μg · 2 trials · 2 indications
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 the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.
Change from baseline in pre-dose trough FEV1 after 2 weeks of treatment with indacaterol acetate 75 μg o.d and 150 μg o.d. The primary endpoint is change from baseline in pre-dose trough FEV1 (mL) after 2 weeks of treatment. The pre-dose trough FEV1 (mL) is defined as the mean of the two FEV1 (mL), values measured at -45 min and -15 min pre-dose.
| Arm | Type | Description |
|---|---|---|
| Indacaterol 75 μg | EXPERIMENTAL | Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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 to indacaterol | PLACEBO_COMPARATOR | Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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 acetate 75 μg o.d. | ACTIVE_COMPARATOR | Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler |
| Indacaterol acetate 150 μg o.d. | ACTIVE_COMPARATOR | Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler |
| Name | Type | Description |
|---|---|---|
| Indacaterol 75 μg | DRUG | Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. |
| Placebo to indacaterol | DRUG | Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. |
| Indacaterol acetate 75 μg | DRUG | Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler |
| Indacaterol acetate 150 μg | DRUG | Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler |
Inclusion criteria: * Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2008) and: * Smoking history of at least 10 pack-years * Post-bronchodilator forced expiratory vo...
Indacaterol 75 μg is an investigational small molecule being developed for asthma and chronic obstructive pulmonary disease (COPD). It is a long-acting bronchodilator intended to improve lung function in patients with these respiratory conditions. The drug is not yet approved and remains in clinical development.
Indacaterol 75 μg is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's efficacy and safety in patients with asthma and COPD.
Indacaterol 75 μg is in Phase 2 clinical development. One Phase 2 trial has been completed, and one Phase 3 trial has also been completed. The drug remains investigational and has not received FDA approval for any indication.
Indacaterol 75 μg has been studied in two completed clinical trials. NCT01072448 was a 12-week Phase 3 study in 323 adults with COPD in the United States. NCT02892019 was a Phase 2 study in 79 children aged 6 to less than 12 years with asthma, conducted across multiple countries.
Indacaterol 75 μg is a long-acting beta2-adrenergic agonist (LABA) that works by relaxing and widening the airways in the lungs. It binds to beta2-adrenergic receptors on bronchial smooth muscle, leading to bronchodilation and improved airflow in patients with asthma and COPD.