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

Novartis logo

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

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

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems