A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma

December 12, 2012 updated by: Novartis Pharmaceuticals

A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma

This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

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.
392

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

  • Belgium
      • Aalst, Belgium
        • Novartis Investigator Site
      • Halen, Belgium
        • Novartis Investigator Site
      • Oostham, Belgium
        • Novartis Investigator Site
      • Veurne, Belgium
        • Novartis Investigator Site
  • Czech Republic
      • Boskovice, Czech Republic
        • Novartis Investigator Site
      • Breclav, Czech Republic
        • Novartis Investigator Site
      • Brno, Czech Republic
        • Novartis Investigator Site
      • Liberec, Czech Republic
        • Novartis Investigator Site
      • Most, Czech Republic
        • Novartis Investigator Site
      • Tabor, Czech Republic
        • Novartis Investigator Site
  • Germany
      • Aalen, Germany
        • Novartis Investigator Site
      • Berlin, Germany
        • Novartis Investigator Site
      • Braunschweig, Germany
        • Novartis Investigator Site
      • Deggendorf, Germany
        • Novartis Investigator Site
      • Furstenwalde, Germany
        • Novartis Investigator Site
      • Leipzig, Germany
        • Novartis Investigator Site
      • Munchen, Germany
        • Novartis Investigator Site
  • Hungary
      • Balassagyarmat, Hungary
        • Novartis Investigator Site
      • Erd, Hungary
        • Novartis Investigator Site
      • Fuzesabony, Hungary
        • Novartis Investigator Site
      • Gyonggyos, Hungary
        • Novartis Investigator Site
      • Mosdoz, Hungary
        • Novartis Investigator Site
      • Pest, Hungary
        • Novartis Investigator Site
      • Siofok, Hungary
        • Novartis Investigator Site
      • Szazhalombatta, Hungary
        • Novartis Investigator Site
  • Israel
      • Afula, Israel
        • Novartis Investigator Site
      • Ashkelon, Israel
        • Novartis Investigator Site
      • Beer Sheva, Israel
        • Novartis Investigator Site
      • Haifa, Israel
        • Novartis Investigator Site
      • Jerusalem, Israel
        • Novartis Investigator Site
      • Petach Tikva, Israel
        • Novartis Investigator Site
      • Rehovot, Israel
        • Novartis Investigator Site
      • Tel Aviv, Israel
        • Novartis Investigator Site
      • Tel-Hashorner, Israel
        • Novartis Investigator Site
      • Zrifin, Israel
        • Novartis Investigator Site
  • Poland
      • Bialystok, Poland
        • Novartis Investigator Site
      • Bydgoszcz, Poland
        • Novartis Investigator Site
      • Lodz, Poland
        • Novartis Investigator Site
      • Lubin, Poland
        • Novartis Investigator Site
      • Tarnow, Poland
        • Novartis Investigator Site
  • Russian Federation
      • Moscow, Russian Federation
        • Novartis Investigator Site
      • Saint-Petersburg, Russian Federation
        • Novartis Investigator Site
      • Smolensk, Russian Federation
        • Novartis Investigator Site
      • Tomsk, Russian Federation
        • Novartis Investigator Site
  • South Africa
      • Bloernfontain, South Africa
        • Novartis Investigator Site
      • Cape Town, South Africa
        • Novartis Investigator Site
      • Johannesburg, South Africa
        • Novartis Investigator Site
      • Krugersdorp, South Africa
        • Novartis Investigator Site
      • Pretoria, South Africa
        • Novartis Investigator Site
      • Roodepoort, South Africa
        • Novartis Investigator Site
      • Temba, South Africa
        • Novartis Investigator Site
      • les Marais, South Africa
        • Novartis Investigator Site
  • Spain
      • Madrid, Spain
        • Novartis Investigator Site
      • Pozuelo de Alacron, Spain
        • Novartis Investigator Site
      • Valencia, Spain
        • Novartis Investigator Site
  • United Kingdom
      • Downpatrick, United Kingdom
        • Novartis Investigator Site
      • Glasgow, United Kingdom
        • Novartis Investigator Site
      • London, United Kingdom
        • Novartis Investigator Site
      • Southampton, United Kingdom
        • Novartis Investigator Site
      • Watford, United Kingdom
        • Novartis Investigator 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

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female adult and adolescent patients aged 12-75 years inclusive (or ≥18-75 years depending upon regulatory and/or Institutional Review Board (IRB)/Independent Ethics Committee (IEC)/Research Ethics Board (REB) approval), who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to Visit 1. Patients below the legal age of consent are required to have the Informed Consent Form signed by the patient's parent / guardian.

  2. Patients with asthma, diagnosed according to Global Initiative for Asthma (GINA) guidelines (National Institute of Health, National Heart, Lung and Blood Institute, 2006) and who additionally meet the following criteria:

    1. Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to Visit 1.
    2. Patients with a Forced Expiratory Volume in one second (FEV1) at Visit 1 of ≥50% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist has been inhaled, and a minimum of 48 hours for a long acting β2-agonist.
    3. Patients who demonstrate an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value within 30 minutes after inhaling a total of 200 µg/180 µg of salbutamol/albuterol Metered Dose Inhaler (MDI) (or equivalent dose of Dry Powder Inhaler [DPI]) (the reversibility test). Reversibility will have to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a short-acting β2-agonist. The administration of salbutamol/albuterol for the reversibility test is to be within 30 minutes after pre bronchodilator spirometry. Reversibility has to be demonstrated at Visit 1 or between Visits 1 and 2, in order for patients to be included in the trial.

Exclusion Criteria:

  • Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
  • Patients with Chronic Obstructive Pulmonary Disease (COPD), or current smokers, or patients who have used tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years.

  • Patients:

    1. who's asthma is likely to deteriorate during the study (including seasonal allergy),
    2. hospitalized for an acute asthma attack/asthma exacerbation within 6 months prior to Visit 1,
    3. who have had an emergency room visit for an asthma attack/asthma exacerbation within 6 weeks prior to Visit 1
    4. who have had a respiratory tract infection or emergency room treatment for an asthma attack/asthma exacerbation within 4 weeks prior to Visit 1
    5. Patients who require the use of ≥8 inhalations per day of short acting B2-agonist (100 µg/ 90 µg salbutamol/albuterol MDI or equivalent dose of DPI) on any 2 consecutive days from Screening to Randomization.

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 62.5 μg
Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
Drug: indacaterol
Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Drug: placebo to formoterol
Placebo AEROLIZER® device
Drug: short acting β2-agonist
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Experimental: indacaterol 125 μg
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
Drug: indacaterol
Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Drug: placebo to formoterol
Placebo AEROLIZER® device
Drug: short acting β2-agonist
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Experimental: indacaterol 500 μg
Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
Drug: indacaterol
Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Drug: placebo to formoterol
Placebo AEROLIZER® device
Drug: short acting β2-agonist
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Active Comparator: formoterol
Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
Drug: formoterol
Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
Drug: placebo to indacaterol
Placebo TWISTHALER® device
Drug: short acting β2-agonist
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Placebo Comparator: placebo
Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
Drug: placebo to formoterol
Placebo AEROLIZER® device
Drug: placebo to indacaterol
Placebo TWISTHALER® device
Drug: short acting β2-agonist
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Experimental: indacaterol 250 μg
Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.
Drug: indacaterol
Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
Drug: placebo to formoterol
Placebo AEROLIZER® device
Drug: short acting β2-agonist
100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).

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
The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline (prior to first dose) and Day 15 (24 hours after last dose)
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
Baseline (prior to first dose) and Day 15 (24 hours after last dose)

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
The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1
Time Frame: Day 1 Baseline (prior to first dose) and 24 hours post-dose.
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate.
Day 1 Baseline (prior to first dose) and 24 hours post-dose.
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14
Time Frame: Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose.
Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose
Number of Participants Using Rescue Medication
Time Frame: Over 14 days
Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period.
Over 14 days
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose
Time Frame: Day 14, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.
FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
Day 14, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1
Time Frame: Day 1, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.
FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate.
Day 1, pre-dose, 5, 20 and 30 minutes, 1, 2, 3, and 4 hours post-dose.
Change From Baseline in Morning and Evening Peak Expiratory Flow
Time Frame: Baseline (recorded during the screening period) and Days 1-14 (treatment period)
The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter and recorded measurements in a diary every morning and evening during the study, prior to taking study medication. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14.
Baseline (recorded during the screening period) and Days 1-14 (treatment period)

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Schering-Plough

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.
October 1, 2007

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.
April 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2008

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).
October 16, 2007

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.
October 16, 2007

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.
October 17, 2007

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.
January 18, 2013

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.
December 12, 2012

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.
November 1, 2012

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.
  • CQMF149A2201
  • 2007-003191-19 (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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