Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease

This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Placebo to indacaterol; Drug: Indacaterol 150 μg

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Lanaken, Belgium
    • Novartis Investigative Site
• New Zealand
  • Tauranga, New Zealand
    • Novartis Investigator Site
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207-5710
      • Novartis Investigative Site
    • Birmingham, Alabama, United States, 35209-6870
      • Novartis Investigative Site
    • Jasper, Alabama, United States, 35501
      • Novartis Investigative Site
    • Mobile, Alabama, United States, 36608-6705
      • Novartis Investigative Site
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Novartis Investigator Site
    • Phoenix, Arizona, United States, 85006-2611
      • Novartis Investigative Site
    • Phoenix, Arizona, United States, 85013-4232
      • Novartis Investigative Site
    • Tucson, Arizona, United States, 85723
      • Novartis Investigative Site
    • Tucson, Arizona, United States, 85712
      • Novartis Investigative Site
  • Arkansas
    • Pine Bluff, Arkansas, United States, 71603
      • Novartis Investigative Site
  • California
    • Buena Park, California, United States, 90620
      • Novartis Investigative Site
    • Encinitas, California, United States, 92024-1332
      • Novartis Investigative Site
    • Fresno, California, United States, 93710
      • Novartis Investigative Site
    • Fullerton, California, United States, 92835
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90048
      • Novartis Investigative Site
    • Orange, California, United States, 92869
      • Novartis Investigative Site
    • Palmdale, California, United States, 93551-1411
      • Novartis Investigative Site
    • Riverside, California, United States, 92506
      • Novartis Investigative Site
    • San Jose, California, United States, 95117
      • Novartis Investigative Site
    • San Mateo, California, United States, 94401
      • Novartis Investigative Site
    • Stockton, California, United States, 95207
      • Novartis Investigative Site
    • Torrance, California, United States, 90503
      • Novartis Investigative Site
    • Vista, California, United States, 92083
      • Novartis Investigative Site
    • Walnut Creek, California, United States, 94598
      • Novartis Investigative Site
  • Colorado
    • Fort Collins, Colorado, United States, 80528-3400
      • Novartis Investigative Site
    • Golden, Colorado, United States, 80401
      • Novartis Investigative Site
    • Wheat Ridge, Colorado, United States, 80033-4300
      • Novartis Investigator Site
  • Delaware
    • Newark, Delaware, United States, 19713
      • Novartis Investigative Site
  • Florida
    • Clearwater, Florida, United States, 33765
      • Novartis Investigative Site
    • Largo, Florida, United States, 33770-2335
      • Novartis Investigative Site
    • Ocala, Florida, United States, 34471
      • Novartis Investigative Site
    • Pensacola, Florida, United States, 32503
      • Novartis Investigative Site
    • Pensacola, Florida, United States, 32504
      • Novartis Investigative Site
    • Pensacola, Florida, United States, 32504-8756
      • Novartis Investigative Site
    • Rockledge, Florida, United States, 32955
      • Novartis Investigative Site
    • Sarasota, Florida, United States, 34233-1272
      • Novartis Investigator Site
    • South Miami, Florida, United States, 33143
      • Novartis Investigative Site
    • Tamarac, Florida, United States, 33321
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33603
      • Novartis Investigative Site
    • Zephyrhills, Florida, United States, 33542-7505
      • Novartis Investigative Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Novartis Investigative Site
    • Austell, Georgia, United States, 30106-1110
      • Novartis Investigative Site
  • Illinois
    • Normal, Illinois, United States, 61761
      • Novartis Investigative Site
    • O fallon, Illinois, United States, 62269
      • Novartis Investigative Site
    • River Forest, Illinois, United States, 60305
      • Novartis Investigative Site
  • Indiana
    • Indianapolis, Indiana, United States, 46285
      • Novartis Investigative Site
  • Iowa
    • Ames, Iowa, United States, 50010
      • Novartis Investigative Site
    • Iowa City, Iowa, United States, 52240
      • Novartis Investigative Site
  • Kansas
    • Shawnee, Kansas, United States, 66216-1800
      • Novartis Investigative Site
  • Kentucky
    • Crescent springs, Kentucky, United States, 41017
      • Novartis Investigative Site
    • Lexington, Kentucky, United States, 40504
      • Novartis Investigative Site
    • Madisonville, Kentucky, United States, 42431
      • Novartis Investigative Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006-4225
      • Novartis Investigative Site
    • Opelousas, Louisiana, United States, 70570
      • Novartis Investigative Site
    • Slidell, Louisiana, United States, 70458
      • Novartis Investigative Site
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Novartis Investigative Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48105-9755
      • Novartis Investigative Site
    • Clarkston, Michigan, United States, 48346
      • Novartis Investigative Site
    • Flint, Michigan, United States, 58532
      • Novartis Investigative Site
    • Livonia, Michigan, United States, 48152
      • Novartis Investigative Site
    • Troy, Michigan, United States, 48085
      • Novartis Investigative Site
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Novartis Investigator Site
    • Minneapolis, Minnesota, United States, 55407
      • Novartis Investigative Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Novartis Investigator Site
    • St Charles, Missouri, United States, 63301-2847
      • Novartis Investigative Site
  • Montana
    • Kalispell, Montana, United States, 59901
      • Novartis Investigative Site
    • Missoula, Montana, United States, 59808
      • Novartis Investigative Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Novartis Investigative Site
    • Omaha, Nebraska, United States, 68134
      • Novartis Investigative Site
    • Omaha, Nebraska, United States, 68114-3570
      • Novartis Investigative Site
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Novartis Investigative Site
    • Las Vegas, Nevada, United States, 89102-4508
      • Novartis Investigative Site
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • Novartis Investigative Site
    • Summit, New Jersey, United States, 07901
      • Novartis Investigative Site
  • New York
    • Cortland, New York, United States, 13045
      • Novartis Investigative Site
    • Rochester, New York, United States, 14618
      • Novartis Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Novartis Investigative Site
    • Charlotte, North Carolina, United States, 28277
      • Novartis Investigative Site
    • High Point, North Carolina, United States, 27262-4320
      • Novartis Investigative Site
    • Shelby, North Carolina, United States, 28150
      • Novartis Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Novartis Investigative Site
    • Cincinnati, Ohio, United States, 45242
      • Novartis Investigator Site
    • Cincinnati, Ohio, United States, 45227
      • Novartis Investigative Site
    • Columbus, Ohio, United States, 43215
      • Novartis Investigative Site
    • Columbus, Ohio, United States, 43213
      • Novartis Investigative Site
    • Marion, Ohio, United States, 43302
      • Novartis Investigative Site
    • Thornville, Ohio, United States, 43076-8010
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Novartis Investigative Site
    • Tulsa, Oklahoma, United States, 74135-2920
      • Novartis Investigative Site
  • Oregon
    • Eugene, Oregon, United States, 97404
      • Novartis Investigative Site
    • Medford, Oregon, United States, 97504-9741
      • Novartis Investigative Site
    • Portland, Oregon, United States, 97213
      • Novartis Investigative Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 15608
      • Novartis Investigative Site
    • Homestead, Pennsylvania, United States, 15120
      • Novartis Investigative Site
    • Pittsburgh, Pennsylvania, United States, 15243-1800
      • Novartis Investigative Site
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Novartis Investigative Site
    • Gaffney, South Carolina, United States, 29340
      • Novartis Investigative Site
    • Greenville, South Carolina, United States, 29615
      • Novartis Investigative Site
    • N. Charleston, South Carolina, United States, 29406-9167
      • Novartis Investigative Site
    • Spartanburg, South Carolina, United States, 29303
      • Novartis Investigative Site
    • Union, South Carolina, United States, 29379
      • Novartis Investigative Site
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • Novartis Investigative Site
  • Texas
    • Amarillo, Texas, United States, 79106
      • Novartis Investigative Site
    • El Paso, Texas, United States, 79902-5107
      • Novartis Investigative Site
    • Ft. Worth, Texas, United States, 76104-4185
      • Novartis Investigative Site
    • New braunfels, Texas, United States, 78130-6113
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78229
      • Novartis Investigative Site
  • Utah
    • Payson, Utah, United States, 84651
      • Novartis Investigative Site
  • Virginia
    • Abingdon, Virginia, United States, 24210-2921
      • Novartis Investigative Site
    • Lynchburg, Virginia, United States, 24501
      • Novartis Investigative Site
    • Richmond, Virginia, United States, 23229
      • Novartis Investigative Site
    • Richmond, Virginia, United States, 23298
      • Novartis Investigative Site
  • Washington
    • Spokane, Washington, United States, 99201
      • Novartis Investigative Site
    • Spokane Valley, Washington, United States, 99216-1092
      • Novartis Investigative Site
    • Tacoma, Washington, United States, 98405
      • Novartis Investigative Site
  • West Virginia
    • Morgantown, West Virginia, United States, 26505-2713
      • Novartis Investigative Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Novartis Investigative Site

Participation Criteria

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:

• Male or female patients aged 40 years or over with moderate to severe chronic obstructive pulmonary disease (COPD) plus

• 20 pack-year smoking history
• Signed informed consent
• Post-bronchodilator forced expiratory volume in 1 second )FEV1) ≥ 30% and < 80% predicted FEV1/FVC (forced vital capacity) < 70%

Exclusion Criteria include:

• History of asthma
• Prior exposure to indacaterol
• Active cancer or history of cancer
• Patients with concomitant pulmonary disease
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
• Patients unable to successfully use a dry-powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Experimental: Indacaterol 150 μg; Patients inhaled indacaterol 150 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 150 μg; 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)	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 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour 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
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2	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 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.	24 hours post-dose on Day 2

Collaborators and Investigators

• Sponsor: Novartis

Publications and helpful links

General Publications

• Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.
• Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.
• Feldman G, Siler T, Prasad N, Jack D, Piggott S, Owen R, Higgins M, Kramer B; INLIGHT 1 study group. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double-blind, randomised, 12-week study. BMC Pulm Med. 2010 Mar 8;10:11. doi: 10.1186/1471-2466-10-11.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: February 15, 2008
• First Submitted That Met QC Criteria: February 15, 2008
• First Posted (Estimate): February 27, 2008

Study Record Updates

• Last Update Posted (Estimate): August 18, 2011
• Last Update Submitted That Met QC Criteria: July 22, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: COPD; indacaterol; chronic obstructive pulmonary disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CQAB149B2346; EUDRACT Number: 2008-000301-11