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Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01068600
First received: February 12, 2010
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Indacaterol
Drug: Placebo to indacaterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 318
Study Start Date: January 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068600

  Hide Study Locations
Locations
United States, Alabama
Novartis Investigative Site
Anniston, Alabama, United States, 36207-5710
Novartis Investigative Site
Jasper, Alabama, United States, 35501
United States, Arizona
Novartis Investigator Site
Glendale, Arizona, United States, 85306
Novartis Investigator Site
Phoenix, Arizona, United States, 85006
United States, California
Novartis Investigator Site
Fullerton, California, United States, 92835
Novartis Investigator Site
Los Angeles, California, United States, 90095
Novartis Investigator Site
Los Angeles, California, United States, 90048
Novartis Investigator Site
Riverside, California, United States, 92506
United States, Florida
Novartis Investigative Site
Clearwater, Florida, United States, 33765
Novartis Investigative Site
Clearwater, Florida, United States, 33756
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
United States, Georgia
Novartis Investigative Site
Atlanta, Georgia, United States, 30342
United States, Illinois
Novartis Investigator Site
Normal, Illinois, United States, 61761
United States, Iowa
Novartis Investigator Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
Novartis Investigative Site
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Novartis Investigator Site
Baton Rouge, Louisiana, United States, 70808
Novartis Investigator Site
Opelousas, Louisiana, United States, 70570
United States, Missouri
Novartis Investigator Site
St. Charles, Missouri, United States, 63301
Novartis Investigator Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Novartis Investigator Site
Lincoln, Nebraska, United States, 68510
Novartis Investigator Site
Omaha, Nebraska, United States, 68114
Novartis Investigator Site
Omaha, Nebraska, United States, 68134
United States, Nevada
Novartis Investigator Site
Henderson, Nevada, United States, 89014
Novartis Investigator Site
Las Vegas, Nevada, United States, 89119
United States, New Jersey
Novartis Investigative Site
Cherry Hill, New Jersey, United States, 08003
United States, New Mexico
Novartis Investigator Site
Albuquerque, New Mexico, United States, 87108
United States, North Carolina
Novartis Investigative Site
Charlotte, North Carolina, United States, 28207
Novartis Investigative Site
Raleigh, North Carolina, United States, 27607
Novartis Investigative Site
Shelby, North Carolina, United States, 28152
United States, Ohio
Novartis Investigative Site
Canton, Ohio, United States, 44718
Novartis Investigator Site
Cincinnati, Ohio, United States, 45242
Novartis Investigative Site
Columbus, Ohio, United States, 43215
Novartis Investigative Site
Columbus, Ohio, United States, 43213
Novartis Investigator Site
Marion, Ohio, United States, 43302
United States, Oregon
Novartis Investigator Site
Eugene, Oregon, United States, 97404
Novartis Investigator Site
Medford, Oregon, United States, 97504
United States, Rhode Island
Novartis Investigative Site
Cumberland, Rhode Island, United States, 02864
Novartis Investigative Site
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Novartis Investigative Site
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
United States, Texas
Novartis Investigator Site
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
United States, Vermont
Novartis Investigative Site
South Burlington, Vermont, United States, 05403
United States, Virginia
Novartis Investigative Site
Richmond, Virginia, United States, 23229
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01068600     History of Changes
Other Study ID Numbers: CQAB149B2355
Study First Received: February 12, 2010
Results First Received: July 22, 2011
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
COPD
Indacaterol

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014