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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01012739
First Posted: November 13, 2009
Last Update Posted: August 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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).

Condition Intervention Phase
Asthma Drug: Indacaterol 150 μg via the Concept1 dry-powder inhaler Drug: Indacaterol 60 μg via the Simoon dry-powder inhaler Drug: Indacaterol 120 μg via the Simoon dry-powder inhaler Drug: Placebo to indacaterol via the Concept1 dry-powder inhaler Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Partially-blinded, Single-dose, 4-way Cross-over Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Maleate Administered Via the Concept1 Device or Via the Simoon Device

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment [ Time Frame: Baseline and Day 1 ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment [ Time Frame: Baseline and Day 1 ]
    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.

  • Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment [ Time Frame: From 5 minutes to 12 hours post-dose ]
    FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.

  • Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose for Each Treatment [ Time Frame: From 5 minutes to 4 hours post-dose for each treatment ]
    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.

  • Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment [ Time Frame: 0 to 24 hours post-dose ]
    All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data using non-compartmental analysis.

  • Indacaterol Exposure (Cmax) for Each Treatment [ Time Frame: 0 to 24 hours post-dose ]
    All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data using non-compartmental analysis.


Enrollment: 35
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
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.
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.
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.
Experimental: 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.
Drug: 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.
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.
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.
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.
Experimental: 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.
Drug: 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.
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.
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.
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.
Experimental: 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.
Drug: 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.
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.
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.
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.

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012739


Locations
Germany
Novartis Investigative Site
Berlin, Germany
Netherlands
Novartis Investigative Site
Groningen, Netherlands
United Kingdom
Novartis Investigative Site
Belfast, United Kingdom
Novartis Investigative Site
Manchester, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01012739     History of Changes
Other Study ID Numbers: CQAB149B2222
2009-012600-48 ( EudraCT Number )
First Submitted: November 12, 2009
First Posted: November 13, 2009
Results First Submitted: July 22, 2011
Results First Posted: August 17, 2011
Last Update Posted: August 29, 2011
Last Verified: August 2011

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
asthma
QAB149
indacaterol
pulmonary function

Additional relevant MeSH terms:
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action