Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Indacaterol 300μg · 3 trials · 1 indication
At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.
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 each treatment period. The analysis included baseline FEV1, defined as the average of the FEV1 values measured at 50 and 15 minutes prior to the first study drug administration in that period, as a covariate.
Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate.
| Arm | Type | Description |
|---|---|---|
| Indacaterol 300 μg followed by placebo | EXPERIMENTAL | Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 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 followed by indacaterol 300 μg | EXPERIMENTAL | Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 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 300 μg - placebo to indacaterol - salmeterol 50 μg | EXPERIMENTAL | In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 - salmeterol 50 μg - indacaterol 300 μg | EXPERIMENTAL | In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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. |
| Salmeterol 50 μg - indacaterol 300 μg - placebo to indacaterol | EXPERIMENTAL | In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 - indacaterol 300 μg - salmeterol 50 μg | EXPERIMENTAL | In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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 300 μg - salmeterol 50 μg - placebo to indacaterol | EXPERIMENTAL | In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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. |
| Salmeterol 50 μg - placebo to indacaterol - indacaterol 300 μg | EXPERIMENTAL | In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. 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. |
| Sequence 1: Indacaterol 300μg followed by Placebo | EXPERIMENTAL | In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. |
| Sequence 2 : Placebo followed by Indacaterol 300μg | EXPERIMENTAL | In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. |
| Name | Type | Description |
|---|---|---|
| Indacaterol 300 μg | DRUG | Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. |
| Placebo | DRUG | Placebo was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. |
| Placebo to indacaterol | DRUG | Placebo to indacaterol was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI). |
| Salmeterol 50 μg | DRUG | Salmeterol 50 μg was provided in powder filled capsules with a multi-dose dry-powder inhaler (MDDPI). |
| Indacaterol 300μg | DRUG | 300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device |
Inclusion Criteria: * Male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure. * Co-operative outpatients with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the GOLD Guidel...
Indacaterol 300 µg is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD) and asthma. It is a long-acting bronchodilator intended to improve lung function and exercise endurance in patients with moderate to severe COPD. The drug is administered via inhalation and is currently in Phase 3 clinical development.
Indacaterol 300 µg is being 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 safety and efficacy of this inhaled medication for respiratory conditions.
Indacaterol 300 µg is in Phase 3 clinical development for chronic obstructive pulmonary disease (COPD). It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trials are completed, and the data will support potential regulatory submissions.
Indacaterol 300 µg has been studied in several completed clinical trials, including NCT00620022, NCT00622635, and NCT00876694. These Phase 3 trials evaluated the drug's effects on exercise endurance, 24-hour lung function, and overall efficacy in patients with moderate to severe COPD across multiple countries.
Indacaterol 300 µg is a long-acting beta2-adrenergic agonist (LABA) that works by relaxing the muscles in the airways, leading to bronchodilation. This mechanism helps improve airflow and reduce symptoms such as breathlessness in patients with chronic obstructive pulmonary disease (COPD). The drug is designed for once-daily inhaled administration.
Indacaterol 300 µg is a specific dose formulation of the drug indacaterol. While indacaterol is available in various strengths, the 300 µg dose is being investigated for its efficacy and safety in treating COPD. The drug is also known by its brand name, which may vary by region.