12-week Efficacy of Indacaterol

July 22, 2011 updated by: Novartis

A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Indacaterol in Patients With Chronic Obstructive Pulmonary Disease

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

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.
323

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 3

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

  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Novartis Investigator Site
    • Arkansas
      • Pine Bluff, Arkansas, United States, 71603
        • Novartis Investigator Site
    • California
      • Buena Park, California, United States, 90620
        • Novartis Investigator Site
      • Encinitas, California, United States, 92024
        • Novartis Investigator Site
      • Fountain Valley, California, United States, 92708
        • Novartis Investigator Site
      • Los Angeles, California, United States, 90015
        • Novartis Investigator Site
      • San Diego, California, United States, 92120
        • Novartis Investigator Site
      • San Diego, California, United States, 92103
        • Novartis Investigator Site
      • Temecula, California, United States, 92591
        • Novartis Investigator Site
      • Torrance, California, United States, 90505
        • Novartis Investigator Site
      • Walnut Creek, California, United States, 94598
        • Novartis Investigator Site
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Novartis Investigator Site
    • Florida
      • Port Orange, Florida, United States, 32127
        • Novartis Investigative Site
      • Sarasota, Florida, United States, 34233
        • Novartis Investigative Site
      • Tamarac, Florida, United States, 33321
        • Novartis Investigative Site
    • Idaho
      • Couer D'Alene, Idaho, United States, 83814
        • Novartis Investigator Site
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Novartis Investigator Site
      • Downers Grove, Illinois, United States, 60515
        • Novartis Investigator Site
      • River Forest, Illinois, United States, 60305
        • Novartis Investigative Site
      • Skokie, Illinois, United States, 60076
        • Novartis Investigator Site
      • Springfield, Illinois, United States, 62703
        • Novartis Investigator Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Novartis Investigative Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Novartis Investigator Site
      • Metaire, Louisiana, United States, 70002
        • Novartis Investigator Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Novartis Investigative Site
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Novartis Investigative Site
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Novartis Investigative Site
      • Flint, Michigan, United States, 48532
        • Novartis Investigative Site
      • Livonia, Michigan, United States, 48152
        • Novartis Investigative Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Novartis Investigative Site
      • Minneapolis, Minnesota, United States, 55402
        • Novartis Investigative Site
      • Plymouth, Minnesota, United States, 55441
        • Novartis Investigative Site
    • Missouri
      • Florissant, Missouri, United States, 63033
        • Novartis Investigator Site
      • Ozark, Missouri, United States, 65721
        • Novartis Investigator Site
      • St. Louis, Missouri, United States, 63117
        • Novartis Investigator Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Novartis Investigative Site
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Novartis Investigator Site
      • Lincoln, Nebraska, United States, 68516
        • Novartis Investigator Site
      • Omaha, Nebraska, United States, 68134
        • Novartis Investigator Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Novartis Investigator Site
      • Pahrump, Nevada, United States, 89048
        • Novartis Investigator Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08902
        • Novartis Investigative Site
      • Ocean, New Jersey, United States, 07712
        • Novartis Investigative Site
    • New York
      • Rochester, New York, United States, 14618
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Novartis Investigative Site
      • Salisbury, North Carolina, United States, 28144
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Novartis Investigative Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Novartis Investigator Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Novartis Investigative Site
      • Erie, Pennsylvania, United States, 16506
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15221
        • Novartis Investigative Site
    • South Carolina
      • Gaffney, South Carolina, United States, 29340
        • Novartis Investigative Site
      • Greer, South Carolina, United States, 29651
        • Novartis Investigative Site
      • Seneca, South Carolina, United States, 29678
        • Novartis Investigative Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Novartis Investigative Site
    • Texas
      • Corsicana, Texas, United States, 75110
        • Novartis Investigator Site
      • Fort Worth, Texas, United States, 76109
        • Novartis Investigator Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Novartis Investigator Site
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Novartis Investigator Site
      • Newport News, Virginia, United States, 23606
        • Novartis Investigative Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • 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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) and:

    • Smoking history of at least 10 pack-years
    • Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
    • Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion criteria:

  • Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular co-morbid conditions Other protocol-defined inclusion/exclusion criteria applied to the study.

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 75 μg
Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Indacaterol 75 μg
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Placebo Comparator: Placebo to indacaterol
Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Drug: Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

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
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)
Time Frame: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
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 at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.
24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)

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
Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)
Time Frame: End of the study (Week 12, Day 84)
An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.
End of the study (Week 12, Day 84)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 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 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.
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).
February 19, 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.
February 19, 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.
February 22, 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 19, 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.
  • CQAB149B2354

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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