Efficacy, Safety and Pharmacokinetics of Different Regimens of Indacaterol

July 22, 2011 updated by: Novartis Pharmaceuticals

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Repeated-dose Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Three Different Dosing Regimens of Inhaled Indacaterol Maleate in Patients With Persistent Asthma

This study assessed the bronchodilator efficacy of three different regimens of indacaterol in patients with asthma

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
191

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Novartis Investigative Site
      • Rennes, France
        • Novartis Investigative Site
  • Germany
      • Wiesbaden, Germany
        • Novartis Investigative Site
  • Jordan
      • Amman, Jordan
        • Novartis Investigative Site
      • Irbid, Jordan
        • Novartis Investigative Site
  • Netherlands
      • Groningen, Netherlands
        • Novartis Investigative Site
  • United Kingdom
      • London, United Kingdom
        • Novartis Investigative Site
      • Manchester, United Kingdom
        • Novartis Investigative Site
      • Merthyr Tydfil, United Kingdom
        • Novartis Investigative Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Novartis Investigative Site
    • California
      • Cypress, California, United States, 90630
        • Novartis Investigative Site
      • Fresno, California, United States, 93726
        • Novartis Investigative Site
      • San Diego, California, United States, 92120
        • Novartis Investigative Site
    • Colorado
      • Denver, Colorado, United States, 80206
        • Novartis Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Novartis Investigative Site
      • Miami, Florida, United States, 33175
        • Novartis Investigative Site
      • Miami, Florida, United States, 33167
        • Novartis Investigative Site
      • Sarasota, Florida, United States, 34233
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33617
        • Novartis Investigative Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Novartis Investigative Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Novartis Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Novartis Investigative Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Novartis Investigative Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Novartis Investigator Site
    • Texas
      • Houston, Texas, United States, 77070
        • Novartis Investigative Site
      • Plano, Texas, United States, 75075
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78212
        • Novartis Investigative Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Novartis Investigative Site
      • Tacoma, Washington, United States, 98418
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a diagnosis of asthma and:
  • Receiving daily treatment with inhaled corticosteroid in a regimen that has been stable for at least a month prior to screening
  • FEV1 ≥50% and ≤90% of predicted normal at screening
  • An increase of ≥12% and ≥200 mL in FEV1 over prebronchodilator value within 30 minutes after inhaling a total dose of albuterol/salbutamol of 360/400 MDI

Exclusion Criteria:

  • Smoking history of ≥ 10 years
  • Patients with a diagnosis of COPD
  • Patients who have been previously intubated for a severe asthma exacerbation/ attack
  • Patients who have experienced a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening
  • Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • Patients with seasonal allergy whose asthma is likely to deteriorate during the study period
  • Patients with Type I or uncontrolled Type II diabetes mellitus

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Indacaterol 37.5 µg (twice a day)

Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days.

All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.
Experimental: Indacaterol 75 µg (once a day)

Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days.

All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.
Drug: Placebo to Indacaterol
Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.
Experimental: Indacaterol 150 µg (every other day)

Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days.

All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol
Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.
Drug: Placebo to Indacaterol
Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.
Placebo Comparator: Placebo

Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days.

All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Drug: Placebo to Indacaterol
Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) After Two Weeks of Treatment
Time Frame: Baseline to week 2
Spirometry was conducted according to internationally accepted standards. Trough FEV1 values were calculated as the mean of the 23.17 hours and 23.75 hours post morning dose FEV1 measurements. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Baseline to week 2
Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 24 Hours Post Dose (FEV1 AUC 0-24h) After Two Weeks of Treatment
Time Frame: Baseline, 0-24 hours post dose week 2
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-24 hours) of FEV1 measurements taken at pre-dose to 24 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Baseline, 0-24 hours post dose week 2
Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 48 Hours (FEV1 AUC 0-48h) After Two Weeks of Treatment
Time Frame: Baseline, 0 to 48 hours post dose week 2
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-48 hours) of FEV1 measurements taken at pre-dose to 48 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Baseline, 0 to 48 hours post dose week 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Forced Expiratory Volume in 1 Second Standardized (With Respect to Time) Area Under the Curve (AUC) From 0 to 12 Hours (FEV1 AUC 0-12h) After Two Weeks of Treatment
Time Frame: Baseline, 0 to 12 hours post dose week 2
Spirometry was conducted according to internationally accepted standards. Standardized area under the curve (AUC 0-12 hours) of FEV1 measurements taken at pre-dose to 12 hours post-dose was calculated based on the trapezoidal rule and was adjusted for the area per time unit by using the scheduled time of measurements for FEV1. Analysis of covariance model was used with baseline FEV1 as a continuous covariate.
Baseline, 0 to 12 hours post dose week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQAB149B2223
  • 2010-018481-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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