Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

318

Phase

  • 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
    • Alabama
      • Anniston, Alabama, United States, 36207-5710
        • Novartis Investigative Site
      • Jasper, Alabama, United States, 35501
        • Novartis Investigative Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Novartis Investigator Site
      • Phoenix, Arizona, United States, 85006
        • Novartis Investigator Site
    • California
      • Fullerton, California, United States, 92835
        • Novartis Investigator Site
      • Los Angeles, California, United States, 90048
        • Novartis Investigator Site
      • Los Angeles, California, United States, 90095
        • Novartis Investigator Site
      • Riverside, California, United States, 92506
        • Novartis Investigator Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Novartis Investigative Site
      • Clearwater, Florida, United States, 33765
        • Novartis Investigative Site
      • Hollywood, Florida, United States, 33021
        • Novartis Investigative Site
      • Miami, Florida, United States, 33145
        • Novartis Investigative Site
      • Tampa, Florida, United States, 33603
        • Novartis Investigative Site
      • Winter Park, Florida, United States, 32789
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Novartis Investigative Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Novartis Investigator Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novartis Investigator Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Novartis Investigative Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Novartis Investigator Site
      • Opelousas, Louisiana, United States, 70570
        • Novartis Investigator Site
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • Novartis Investigator Site
      • St. Louis, Missouri, United States, 63141
        • Novartis Investigator Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Novartis Investigator Site
      • Omaha, Nebraska, United States, 68114
        • Novartis Investigator Site
      • Omaha, Nebraska, United States, 68134
        • Novartis Investigator Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Novartis Investigator Site
      • Las Vegas, Nevada, United States, 89119
        • Novartis Investigator Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • Novartis Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Novartis Investigator Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Novartis Investigative Site
      • Raleigh, North Carolina, United States, 27607
        • Novartis Investigative Site
      • Shelby, North Carolina, United States, 28152
        • Novartis Investigative Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Novartis Investigative Site
      • Cincinnati, Ohio, United States, 45242
        • Novartis Investigator Site
      • Columbus, Ohio, United States, 43215
        • Novartis Investigative Site
      • Columbus, Ohio, United States, 43213
        • Novartis Investigative Site
      • Marion, Ohio, United States, 43302
        • Novartis Investigator Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Novartis Investigator Site
      • Medford, Oregon, United States, 97504
        • Novartis Investigator Site
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Novartis Investigative Site
      • Pawtucket, Rhode Island, United States, 02860
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Novartis Investigative Site
      • Charleston, South Carolina, United States, 29412
        • Novartis Investigative Site
      • Easley, South Carolina, United States, 29640
        • Novartis Investigative Site
      • Greenville, South Carolina, United States, 29615
        • Novartis Investigative Site
      • North Charleston, South Carolina, United States, 29406
        • Novartis Investigative Site
      • Spartanburg, South Carolina, United States, 29303
        • Novartis Investigative Site
      • Union, South Carolina, United States, 29379
        • Novartis Investigative Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Novartis Investigator Site
      • Dickinson, Texas, United States, 77539
        • Novartis Investigator Site
      • El Paso, Texas, United States, 79903
        • Novartis Investigator Site
      • McKinney, Texas, United States, 75069
        • Novartis Investigator Site
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Novartis Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23229
        • 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

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 COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

    1. Smoking history of at least 10 pack-years
    2. Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
    3. 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 for 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 comorbid conditions

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
Intervention / Treatment
Experimental: Indacaterol 75 µg

Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Drug: Indacaterol
Once daily via single-dose dry powder inhaler (SDDPI)
Placebo Comparator: Placebo

Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Drug: Placebo to indacaterol
Once daily via SDDPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
Time Frame: after 12 weeks
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.
after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment
Time Frame: after 12 weeks
TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.
after 12 weeks

Collaborators and Investigators

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

Sponsor

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

January 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 12, 2010

First Submitted That Met QC Criteria

February 12, 2010

First Posted (Estimate)

February 15, 2010

Study Record Updates

Last Update Posted (Estimate)

August 19, 2011

Last Update Submitted That Met QC Criteria

July 22, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQAB149B2355

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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