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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

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.

Group Type EXPERIMENTAL

Indacaterol 150 μg via the Concept1 dry-powder inhaler

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.

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

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.

Group Type EXPERIMENTAL

Indacaterol 150 μg via the Concept1 dry-powder inhaler

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.

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

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.

Group Type EXPERIMENTAL

Indacaterol 150 μg via the Concept1 dry-powder inhaler

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.

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

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.

Group Type EXPERIMENTAL

Indacaterol 150 μg via the Concept1 dry-powder inhaler

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.

Interventions

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Indacaterol 150 μg via the Concept1 dry-powder inhaler

Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.

Intervention Type DRUG

Indacaterol 60 μg via the Simoon dry-powder inhaler

Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.

Intervention Type DRUG

Indacaterol 120 μg via the Simoon dry-powder inhaler

Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.

Intervention Type DRUG

Placebo to indacaterol via the Concept1 dry-powder inhaler

Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No