Approval Probability
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Adjusted LOA
ML Risk
Also known as Indacaterol 150 μg via the Concept1 dry-powder inhaler
Indacaterol 150 μg via the Concept1 dry- inhaler · 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 for each treatment.
| Arm | Type | Description |
|---|---|---|
| Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg | EXPERIMENTAL | In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo | EXPERIMENTAL | In treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg | EXPERIMENTAL | In treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg | EXPERIMENTAL | In treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Name | Type | Description |
|---|---|---|
| Indacaterol 150 μg via the Concept1 dry-powder inhaler | DRUG | Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler. |
| Indacaterol 60 μg via the Simoon dry-powder inhaler | DRUG | Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler. |
| Indacaterol 120 μg via the Simoon dry-powder inhaler | DRUG | Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler. |
| Placebo to indacaterol via the Concept1 dry-powder inhaler | DRUG | Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler. |
Inclusion criteria: * Patients with persistent asthma with a forced expiratory volume in 1 second (FEV1) ≥ 50% * Patients using inhaled corticosteroid (with or without long-acting beta agonist) Exclusion criteria: * Asthma exacerbations in previous 6 months * Chronic obstructive pulmonary disease...