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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

323

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
    • 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

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
Intervention / Treatment
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

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

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

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)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria

February 19, 2010

First Posted (Estimate)

February 22, 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

  • 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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