12-week Efficacy of Indacaterol

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01072448
First received: February 19, 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 75 μg
Drug: Placebo to indacaterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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) 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 323
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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.
  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: NCT01072448

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Locations
United States, Arizona
Novartis Investigator Site
Peoria, Arizona, United States, 85381
United States, Arkansas
Novartis Investigator Site
Pine Bluff, Arkansas, United States, 71603
United States, California
Novartis Investigator Site
Buena Park, California, United States, 90620
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Encinitas, California, United States, 92024
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Fountain Valley, California, United States, 92708
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Los Angeles, California, United States, 90015
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San Diego, California, United States, 92103
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San Diego, California, United States, 92120
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Temecula, California, United States, 92591
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Torrance, California, United States, 90505
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Walnut Creek, California, United States, 94598
United States, Colorado
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Wheat Ridge, Colorado, United States, 80033
United States, Florida
Novartis Investigative Site
Port Orange, Florida, United States, 32127
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Sarasota, Florida, United States, 34233
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Tamarac, Florida, United States, 33321
United States, Idaho
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Couer D'Alene, Idaho, United States, 83814
United States, Illinois
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Champaign, Illinois, United States, 61820
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Downers Grove, Illinois, United States, 60515
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River Forest, Illinois, United States, 60305
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Skokie, Illinois, United States, 60076
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Springfield, Illinois, United States, 62703
United States, Kentucky
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Lexington, Kentucky, United States, 40504
United States, Louisiana
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Covington, Louisiana, United States, 70433
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Metaire, Louisiana, United States, 70002
United States, Maine
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Bangor, Maine, United States, 04401
United States, Maryland
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Columbia, Maryland, United States, 21044
United States, Michigan
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Clarkston, Michigan, United States, 48346
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Flint, Michigan, United States, 48532
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Livonia, Michigan, United States, 48152
United States, Minnesota
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Edina, Minnesota, United States, 55435
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Minneapolis, Minnesota, United States, 55402
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Plymouth, Minnesota, United States, 55441
United States, Missouri
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Florissant, Missouri, United States, 63033
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Ozark, Missouri, United States, 65721
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St. Louis, Missouri, United States, 63117
United States, Montana
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Missoula, Montana, United States, 59808
United States, Nebraska
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Bellevue, Nebraska, United States, 68123
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Lincoln, Nebraska, United States, 68516
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Omaha, Nebraska, United States, 68134
United States, Nevada
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Henderson, Nevada, United States, 89014
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Pahrump, Nevada, United States, 89048
United States, New Jersey
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New Brunswick, New Jersey, United States, 08902
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Ocean, New Jersey, United States, 07712
United States, New York
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Rochester, New York, United States, 14618
United States, North Carolina
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Charlotte, North Carolina, United States, 28209
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Salisbury, North Carolina, United States, 28144
United States, Ohio
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Cincinnati, Ohio, United States, 45231
United States, Oregon
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Medford, Oregon, United States, 97504
United States, Pennsylvania
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Beaver, Pennsylvania, United States, 15009
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Erie, Pennsylvania, United States, 16506
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Pittsburgh, Pennsylvania, United States, 15243
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Pittsburgh, Pennsylvania, United States, 15221
United States, South Carolina
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Gaffney, South Carolina, United States, 29340
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Greer, South Carolina, United States, 29651
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Seneca, South Carolina, United States, 29678
United States, Tennessee
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Johnson City, Tennessee, United States, 37601
United States, Texas
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Corsicana, Texas, United States, 75110
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Fort Worth, Texas, United States, 76109
United States, Utah
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Salt Lake City, Utah, United States, 84107
United States, Virginia
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Abingdon, Virginia, United States, 24210
Novartis Investigative Site
Newport News, Virginia, United States, 23606
United States, Washington
Novartis Investigator Site
Tacoma, Washington, United States, 98405
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: NCT01072448     History of Changes
Other Study ID Numbers: CQAB149B2354
Study First Received: February 19, 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, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014