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 inhaled small molecule developed for respiratory conditions, specifically asthma and chronic obstructive pulmonary disease (COPD). It is delivered via the Concept1 inhalation device. The asthma program studied children aged 6 to under 12 years, while the COPD program studied adults aged 40 and older.
Indacaterol 75 μg targets ADRB2, the beta-2 adrenergic receptor, and acts as an agonist at that receptor. Agonist activity at ADRB2 is the mechanism behind its bronchodilator effect in the airways. The drug is a small molecule administered by inhalation.
Indacaterol 75 μg is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor behind the clinical program for this inhaled respiratory asset.
Indacaterol 75 μg is in Phase 2 development and is investigational. It has not been approved by the FDA for the indications studied. The Phase 2 work focused on asthma in children, while a separate Phase 3 study evaluated the drug in chronic obstructive pulmonary disease.
Indacaterol 75 μg has been studied in two completed trials. NCT02892019 was a Phase 2 trial of indacaterol acetate via the Concept1 device in children aged 6 to under 12 with asthma, enrolling 79 patients. NCT01072448 was a Phase 3, 12-week efficacy trial in COPD enrolling 323 patients.