Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices

Novartis

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler; Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler; Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler; Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01012739

CQAB149B2222

2009-012600-48 (EudraCT Number)

Details and patient eligibility

About

This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the established formulation (Concept1).

Full description

This study was double-blind with regards to the Concept1, where placebo for the lactose-blended indacaterol was available. However, with regards to the Simoon, neither the subject nor the investigator was blinded due to lack of a placebo to the PulmoSphere formulation. Hence, the overall designation of the study was partially-blind.

Enrollment: 35 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 (COPD) or other pulmonary disease
• Excessive use of short-acting beta agonists

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 4 patient groups

Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg

Experimental group

Description:

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.

Treatment:

Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler

Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler

Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler

Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler

Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo

Experimental group

Description:

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.

Treatment:

Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler

Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler

Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler

Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler

Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg

Experimental group

Description:

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.

Treatment:

Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler

Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler

Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler

Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler

Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg

Experimental group

Description:

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.

Treatment:

Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler

Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler

Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler

Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler