26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease Using Blinded Formoterol (12 µg b.i.d.) and Open Label Tiotropium (18 µg o.d.) as Active Controls

Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 & 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

Study Overview

• Status: Completed
• Conditions: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; COPD
• Intervention / Treatment: Drug: Indacaterol; Drug: Placebo to Indacaterol; Drug: Placebo to Formoterol; Drug: Tiotropium (18 µg o.d.); Drug: Formoterol (12 µg b.i.d.)

• Study Type: Interventional
• Enrollment (Actual): 2059
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Novartis
  • Buenos Aires, Argentina
    • Novartis Investigator Site
  • Capital Federal, Argentina
    • Novartis Investigator Site
  • Santa Fe, Argentina
    • Novartis Investigator Site
• Canada
  • Ajax, Canada
    • Novartis Investigator Site
  • Calgary, Canada
    • Novartis Investigator Site
  • Chatham, Canada
    • Novartis Investigator Site
  • Gatineau, Canada
    • Novartis Investigator Site
  • Moncton, Canada
    • Novartis Investigator Site
  • Montreal, Canada
    • Novartis Investigator Site
  • Niagara Falls, Canada
    • Novartis Investigator Site
  • Ottawa, Canada
    • Novartis Investigator Site
  • Quebec, Canada
    • Novartis
  • Saskatoon, Canada
    • Novartis Investigator Site
  • Sherbrooke, Canada
    • Novartis Investigator Site
  • St John, Canada
    • Novartis Investigator Site
  • St John's, Canada
    • Novartis Investigator Site
  • St Romuald, Canada
    • Novartis Investigator Site
  • Ste-Foy, Canada
    • Novartis Investigator Site
  • Toronto, Canada
    • Novartis Investigator Site
  • Trois-Rivieres, Canada
    • Novartis Investigator Site
  • Vancouver, Canada
    • Novartis Investigator Site
  • Waterloo, Canada
    • Novartis Investigator Site
  • Windsor, Canada
    • Novartis Investigator Site
  • Winnipeg, Canada
    • Novartis Investigator Site
• Germany
  • Augsburg, Germany
    • Novartis Investigator Site
  • Bad Segeberg, Germany
    • Novartis Investigator Site
  • Berlin, Germany
    • Novartis Investigator Site
  • Bielefeld, Germany
    • Novartis Investigator Site
  • Bonn, Germany
    • Novartis Investigator Site
  • Bruhl, Germany
    • Novartis Investigator Site
  • Dachau, Germany
    • Novartis Investigator Site
  • Fuerth, Germany
    • Novartis
  • Hamburg, Germany
    • Novartis Investigator Site
  • Hoyerswerda, Germany
    • Novartis Investigator Site
  • Kaufbeuren, Germany
    • Novartis Investigator Site
  • Landsberg, Germany
    • Novartis Investigator Site
  • Leipzig, Germany
    • Novartis Investigator Site
  • Mainz, Germany
    • Novartis Investigator Site
  • Muenchen, Germany
    • Novartis Investigator Site
  • Oranienburg, Germany
    • Novartis Investigator Site
  • Oschersleben, Germany
    • Novartis Investigator Site
  • Potsdam, Germany
    • Novartis Investigator Site
  • Ratingen, Germany
    • Novartis Investigator Site
  • Steinfurt, Germany
    • Novartis Investigator Site
  • Wuppertal, Germany
    • Novartis Investigator Site
• India
  • Bangalore, India
    • Novartis Investigator Site
  • Banglore, India
    • Novartis Investigator Site
  • Caranazalem, India
    • Novartis Investigator Site
  • Chennai, India
    • Novartis Investigator Site
  • Coimbatore, India
    • Novartis Investigator Site
  • Hyderabaad, India
    • Novartis Investigator Site
  • Indore, India
    • Novartis Investigator Site
  • Jaipur, India
    • Novartis Investigator Site
  • Kolkatta, India
    • Novartis Investigator Site
  • Ludhiana, India
    • Novartis Investigator Site
  • Mumbai, India
    • Novartis Investigator Site
  • Trivandrum, India
    • Novartis Investigator Site
• Italy
  • Bologna, Italy
    • Novartis Investigator Site
  • Busto Arsizio, Italy
    • Novartis Investigator Site
  • Catania, Italy
    • Novartis Investigator Site
  • Catanzaro, Italy
    • Novartis Investigator Site
  • Chioggia, Italy
    • Novartis Investigator Site
  • Crema, Italy
    • Novartis Investigator Site
  • Ferrara, Italy
    • Novartis Investigator Site
  • Firenze, Italy
    • Novartis Investigator Site
  • Genova, Italy
    • Novartis Investigator Site
  • Messina, Italy
    • Novartis Investigator Site
  • Milano, Italy
    • Novartis Investigator Site
  • Milano, Italy
    • Novartis
  • Pisa, Italy
    • Novartis Investigator Site
  • Roma, Italy
    • Novartis Investigator Site
  • Rozzano, Italy
    • Novartis Investigator Site
  • Siena, Italy
    • Novartis Investigator Site
• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Novartis Investigator Site
  • Busan, Korea, Republic of
    • Novartis Investigator Site
  • Chuncheon, Korea, Republic of
    • Novartis Investigator Site
  • Daegu, Korea, Republic of
    • Novartis Investigator Site
  • Kwangju, Korea, Republic of
    • Novartis Investigator Site
  • Seoul, Korea, Republic of
    • Novartis Investigator Site
  • Seoul, Korea, Republic of
    • Novartis
  • Suwon, Korea, Republic of
    • Novartis Investigator Site
  • Wonju, Korea, Republic of
    • Novartis Investigator Site
• Puerto Rico
  • Ponce, Puerto Rico, 716
    • Novartis Investigator Site
• Spain
  • Alicante, Spain
    • Novartis Investigator Site
  • Barcelona, Spain
    • Novartis Investigator Site
  • Barcelona, Spain
    • Novartis
  • Burgos, Spain
    • Novartis Investigator Site
  • Cadiz, Spain
    • Novartis Investigator Site
  • Calde Lugo, Spain
    • Novartis Investigator Site
  • Galdakano, Spain
    • Novartis Investigator Site
  • Gerona, Spain
    • Novartis Investigator Site
  • Gran Canaria, Spain
    • Novartis Investigator Site
  • La Coruna, Spain
    • Novartis Investigator Site
  • Madrid, Spain
    • Novartis Investigator Site
  • Malaga, Spain
    • Novartis Investigator Site
  • Orense, Spain
    • Novartis Investigator Site
  • Oviedo, Spain
    • Novartis Investigator Site
  • Palma de Mallorca, Spain
    • Novartis Investigator Site
  • Ponferrada, Spain
    • Novartis Investigator Site
  • Pontevedra, Spain
    • Novartis Investigator Site
  • Puerto de Sagunto, Spain
    • Novartis Investigator Site
  • Sevilla, Spain
    • Novartis Investigator Site
  • Valencia, Spain
    • Novartis Investigator Site
  • Vic, Spain
    • Novartis Investigator Site
  • Vila-Real, Spain
    • Novartis Investigator Site
  • Zaragoza, Spain
    • Novartis Investigator Site
• Sweden
  • Goteborg, Sweden
    • Novartis
  • Jonkoping, Sweden
    • Novartis Investigator Site
  • Lidingo, Sweden
    • Novartis Investigator Site
  • Lulea, Sweden
    • Novartis Investigator Site
  • Lund, Sweden
    • Novartis Investigator Site
• Taiwan
  • Chiayi, Taiwan
    • Novartis Investigator Site
  • LinKou, Taiwan
    • Novartis Investigator Site
  • Taichung, Taiwan
    • Novartis Investigator Site
  • Taipei, Taiwan
    • Novartis Investigator Site
  • Taipei, Taiwan
    • Novartis
• Turkey
  • Anakara, Turkey
    • Novartis Investigator Site
  • Istanbul, Turkey
    • Novartis
  • Izmir, Turkey
    • Novartis Investigator Site
  • Konya, Turkey
    • Novartis Investigator Site
  • Manisa, Turkey
    • Novartis Investigator Site
  • Mersin, Turkey
    • Novartis Investigator Site
  • Yenisehir, Turkey
    • Novartis Investigator Site
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group, LLC
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
    • Homewood, Alabama, United States, 35209
      • Pulmonary Medicine Associates PC
    • Jasper, Alabama, United States, 35501
      • Jasper Summit Research
    • Mobile, Alabama, United States, 36608
      • Pulmonary Associate of Mobile, PC
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Pulmonary Associates, PA
    • Phoenix, Arizona, United States, 85006
      • Pulmonary Associates, PA
    • Scottsdale, Arizona, United States, 85258
      • Arizona Pulmonary Specialists, Ltd
    • Scottsdale, Arizona, United States, 85255
      • Novartis Investigative Center
    • Tempe, Arizona, United States, 85282
      • Premiere Pharmaceutical Research, LLC
    • Tucson, Arizona, United States, 85712
      • Canyon Clinical Research, LLC
    • Tucson, Arizona, United States, 85723
      • SAVAHSC / Pulmonary Section
  • Arkansas
    • Pine Bluff, Arkansas, United States, 71603
      • Novartis Investigator Site
  • California
    • Buena Park, California, United States, 90620
      • Novartis Investigator Site
    • Downey, California, United States, 90242
      • USC Rancho Amigos Medical Center
    • Encinitas, California, United States, 92024
      • Encompass Clinical Research - North Coast
    • Fullerton, California, United States, 92835
      • California Research
    • Huntington Beach, California, United States, 92647
      • Allergy and Asthma Specialists Medical Group and Research Center
    • Los Alamitos, California, United States, 90720
      • Interlink Research Institute
    • Los Angeles, California, United States, 90048
      • Southern California Institute for Respiratory Diseases
    • Los Angeles, California, United States, 90025
      • Allergy Research Foundation, Inc
    • Los Angeles, California, United States, 90033
      • Novartis Investigator Site
    • Los Angeles, California, United States, 90095
      • David Geffen UCLA School of Medicine
    • Orange, California, United States, 92869
      • Advance Clinical Research Institute
    • Palmdale, California, United States, 93551
      • California Allergy & Asthma Medical Group
    • Riverside, California, United States, 92506
      • Intergrated Research Group
    • San Jose, California, United States, 95117
      • Allergy & Asthma Associates of Santa Clara Res. Center
    • Sepulveda, California, United States, 91343
      • Greater Los Angeles Healthcare System
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Stockton, California, United States, 95207
      • Bensch Clinical Research Associates
    • Torrance, California, United States, 90505
      • Peninsula Pulmonary Medical Associates
    • Vista, California, United States, 92083
      • Progressive Clinical Research
    • Walnut Creek, California, United States, 94598
      • Allergy and Asthma Clinical Research Inc
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Boulder Medical Center
    • Denver, Colorado, United States, 80206
      • National Jewish Medical & Research Center
    • Fort Collins, Colorado, United States, 80528
      • Northern Colorado Pulmonary Consultants, PC
    • Golden, Colorado, United States, 80401
      • New West Physicians Clinical Research
    • Wheat Ridge, Colorado, United States, 80033
      • Rocky Mountain Center for Clinical Research
    • Wheat Ridge, Colorado, United States, 80033
      • Western States Clinical Research
  • Connecticut
    • Norwalk, Connecticut, United States, 06856
      • Norwalk Hospital
  • Delaware
    • Newark, Delaware, United States, 19713
      • Lung Health & Sleep Enhancement Center
  • Florida
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • Gainesville, Florida, United States, 32610 - 0277
      • University of Florida Shands Hospital
    • Jacksonville, Florida, United States, 32209
      • Shands Jacksonville Medical Center
    • Largo, Florida, United States, 33770
      • Innovative Research of West Florida
    • Miami, Florida, United States, 33136
      • University of Miami School of Medicine
    • Miami, Florida, United States, 33169
      • Elite Research Institute
    • Pembroke Pines, Florida, United States, 33029
      • Novartis Investigator Site
    • Pensacola, Florida, United States, 32504
      • Pensacola Research Consultants
    • Pensacola, Florida, United States, 32504
      • Emerald Coast Clinical Research, LLC
    • Pensacola, Florida, United States, 32514
      • Integrity Research
    • Rockledge, Florida, United States, 32955
      • Brevard Pulmonary Specialists
    • Sarasota, Florida, United States, 34233
      • Asthma & Allergy Research Center
    • South Miami, Florida, United States, 33143
      • South Miami Clinical Research, LLC
    • Tamarac, Florida, United States, 33321
      • Central Medical Group, PA
    • Tamarac, Florida, United States, 33321
      • Clireco, Inc
    • Tampa, Florida, United States, 33613
      • University of South Florida
    • Tampa, Florida, United States, 33603
      • Novartis Investigator Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Neutrotrials Research Inc
    • Austell, Georgia, United States, 30106
      • Georgia Clinical Research
    • Marietta, Georgia, United States, 30060
      • Marietta Pulmonary Medicine
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Hospital
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze & Itch Associates, LLC
    • O'Fallon, Illinois, United States, 62269
      • Southern Illinois Clinical Research Center
    • River Forest, Illinois, United States, 60305
      • Novartis Investigator Site
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Community Hospital Anderson
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group LLC
    • South Bend, Indiana, United States, 46617
      • South Bend Clinic
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
    • Iowa City, Iowa, United States, 52240
      • Iowa Clinical Research Corporation
  • Kansas
    • Shawnee Mission, Kansas, United States, 66216
      • Heart of America Research Institute
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center
  • Kentucky
    • Crescent Springs, Kentucky, United States, 41017
      • Novartis Investigator Site
    • Lexington, Kentucky, United States, 40504
      • Kentucky Medical Research Center
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center
    • Louisville, Kentucky, United States, 40215
      • Family Asthma and Allergy Research Associates
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Gulf Coast Research, LLC
    • Metaire, Louisiana, United States, 70002
      • Rx R&D
    • New Orleans, Louisiana, United States, 70119
      • New Orleans Center for Clinical Research
    • New Orleans, Louisiana, United States, 70112
      • LSU Health Sciences Center/LSU School of Medicine
    • Shreveport, Louisiana, United States, 71103
      • Louisiana Health Sciences Center
    • Slidell, Louisiana, United States, 70461
      • Northshore Research Associates
  • Maine
    • Bangor, Maine, United States, 04401
      • Allergy, Asthma, Immunology, Pharmaceutical Studies
    • Biddeford, Maine, United States, 04005
      • Primecare Physician Associates
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • John Hopkins Asthma and Allergy Center
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Miray Medical Center
    • Worcester, Massachusetts, United States, 01604
      • Fallon Clinic at Worcester Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48106-0525
      • ClinSite, Inc
    • Clarkston, Michigan, United States, 48346
      • Novartis Investigator Site
    • Detroit, Michigan, United States, 48201
      • Harper University Hospital; Wayne State University
    • Flint, Michigan, United States, 48532
      • Novartis Investigator Site
    • Livonia, Michigan, United States, 48152
      • Pulmonary Respiratory Institute of Southwest Michigan
    • Port Huron, Michigan, United States, 48060
      • Novartis Investigator Site
    • Saginaw, Michigan, United States, 48602 - 5303
      • Synergy Medical Education Alliance
    • Troy, Michigan, United States, 48085
      • Novartis Investigator Site
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Minnesota Lung Center
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
    • Minneapolis, Minnesota, United States, 55402
      • Novartis Investigator Site
    • Minneapolis, Minnesota, United States, 55407
      • Minnesota Lung Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Luke's Cardio-Pulmonary Research
    • Columbia, Missouri, United States, 65212
      • University of Missouri - Columbia
    • Kansas City, Missouri, United States, 64106 - 1453
      • Kansas City University Of Medicine And Biosciences
    • Kansas City, Missouri, United States, 64108-2677
      • University of Missouri KC/ Truman Medical
    • St, Louis, Missouri, United States, 63141
      • The Clinical Research Centre
    • St. Charles, Missouri, United States, 63301
      • Midwest Chest Consultants
    • St. Louis, Missouri, United States, 63110
      • Washington U School of Medicine, Center for Clinical Studies
  • Montana
    • Billings, Montana, United States, 59102
      • Montana Health Research Institute
    • Kalispell, Montana, United States, 59901
      • Novartis Investigator Site
    • Missoula, Montana, United States, 59808
      • Novartis Investigator Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Somnos Laboratories, Inc
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC
    • Omaha, Nebraska, United States, 68105
      • Omaha VA Medical Center
    • Omaha, Nebraska, United States, 68134
      • Heartland Clinical Research, Inc
    • Omaha, Nebraska, United States, 68130
      • Midwest Allergy and Asthma Clinic
    • Omaha, Nebraska, United States, 68131
      • Creighton University Centre for Allergy, Asthma & Immunology
    • Omaha, Nebraska, United States, 68131
      • Creigton University
    • Omaha, Nebraska, United States, 68198 - 5885
      • University of Nebraska Medical Center - Pulmonary Research
    • Papillion, Nebraska, United States, 68046
      • The Asthma & Allergy Center, PC
  • Nevada
    • Henderson, Nevada, United States, 89014
      • Lovelace Scientific Resources, Inc.
    • Las Vegas, Nevada, United States, 89131
      • Clinical Research Center of NV
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • Delaware Valley Clinical Research
    • East Brunswick, New Jersey, United States, 08816
      • Pulmonary and Critical Care Associates, PA
    • Newark, New Jersey, United States, 7101
      • Novartis Investigator Site
    • Summit, New Jersey, United States, 07901
      • Pulmonary and Allergy Associates, PA
  • New York
    • Albany, New York, United States, 12205
      • Pulmonary and Critical Care Services
    • Astoria, New York, United States, 11102
      • Crescent Medical Associates
    • Cortland, New York, United States, 13045
      • Asthma and Allergy Associates
    • Elmira, New York, United States, 14905
      • Asthma and Allergy Associates
    • Massapequa, New York, United States, 11758
      • Nassau Chest Physicians, PC
    • New Hyde Park, New York, United States, 11040
      • North Shore University Hospital
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • New York, New York, United States, 10021
      • Weill Medical College of Cornell University
    • New York, New York, United States, 10016
      • New York Pulmonary Associates, PC
    • Rochester, New York, United States, 14618
      • AAIR research Centre
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Sensenbrenner Primary Care
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
    • Shelby, North Carolina, United States, 28150
      • Novartis Investigator Site
    • Winston Salem, North Carolina, United States, 27103
      • Cloverdale Research Facility
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Merit Care Medical Group
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati VA Hospital
    • Cincinnati, Ohio, United States, 452242
      • New Horizons Clinical Research
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Centre
    • Cincinnati, Ohio, United States, 45245
      • Community Research Inc
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Of Cleveland
    • Cleveland, Ohio, United States, 44109-1998
      • Metro Health Medical Center
    • Columbus, Ohio, United States, 43215
      • Remington-Davis Clinical Research
    • Columbus, Ohio, United States, 43213
      • Novartis Investigator Site
    • Columbus, Ohio, United States, 43210
      • Ohio State University - Davis Heart and Lung Research Institute
    • Columbus, Ohio, United States, 43235
      • Novartis Investigator Site
    • Marion, Ohio, United States, 43302
      • Novartis Investigator Site
    • Sylvania, Ohio, United States, 43650
      • John Winder Associates
    • Thornville, Ohio, United States, 43076
      • Advanced Health Care Specialists
    • Toledo, Ohio, United States, 43614
      • The University of Toledo
    • Zanesville, Ohio, United States, 43701
      • Pharmacotherapy Research Associates, Inc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Science Center
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Allergy and Asthma Clinic
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynne Health Science Institute
    • Tulsa, Oklahoma, United States, 74135
      • Healthcare Research Consultants, Inc
  • Oregon
    • Eugene, Oregon, United States, 97404
      • River Road Medical Group
    • Medford, Oregon, United States, 97504
      • Clinical Research Institute of Southern Oregon, PC
    • Medford, Oregon, United States, 97504
      • Oregon Clinical Research Associates
    • Portland, Oregon, United States, 97213
      • Allergy Associates Research Center
    • Portland, Oregon, United States, 97227-1110
      • Novartis Investigator Site
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009 - 1957
      • Tri-State Medical Group
    • Easton, Pennsylvania, United States, 18045
      • Novartis Investigator Site
    • Erie, Pennsylvania, United States, 16506
      • Chest Diseases of Northwestern PA
    • Philadelphia, Pennsylvania, United States, 19107
      • Drexel University College of Medicine
    • Philadelphia, Pennsylvania, United States, 19107
      • Asthma Allergy &Pulmonary Associates, PC
    • Philadelphia, Pennsylvania, United States, 19140
      • Novartis Investigator Site
    • Philadelphia, Pennsylvania, United States, 19141
      • Novartis Investigator Site
    • Pittsburgh, Pennsylvania, United States, 15025
      • Pittsburgh Pulmonary Associates
    • Pittsburgh, Pennsylvania, United States, 15243
      • South Hills Pulmonary Associates
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • New England Center for Clinical Research
    • Cumberland, Rhode Island, United States, 02864
      • Partners in Clinical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29406-7108
      • Low County Lung and Critical Care, PA
    • Charleston, South Carolina, United States, 29412
      • Hugh D. Durrence, MD, Family Medicine
    • Garden City, South Carolina, United States, 29576
      • Med Plus South - Strand Family Practice
    • Greenville, South Carolina, United States, 29615
      • Novartis Investigator Site
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Pharmaceutical Research
    • Varnville, South Carolina, United States, 29944
      • Palmetto Pulmonary Medicine, PA - Sleep Disorders Lab
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • MultiSpeciality Clinical Research
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
    • Knoxville, Tennessee, United States, 37920
      • Volunteer Research Center
    • Nashville, Tennessee, United States, 37203
      • Dickson Family Medicine Group, PC
    • Nashville, Tennessee, United States, 37208-3599
      • Novartis Investigator Site
    • New Tazewell, Tennessee, United States, 37825-1409
      • Heartland Medical, P.C
  • Texas
    • Amarillo, Texas, United States, 79106
      • PharmaTex Research LLC
    • Corsicana, Texas, United States, 75110
      • Trinity Clinic - Corsicana
    • Dallas, Texas, United States, 75231-4307
      • Pharmaceutical Research & Consulting, Inc
    • Dallas, Texas, United States, 75231
      • Asthma & Allergy Research Associates
    • El Paso, Texas, United States, 79902
      • Western Sky Medical Research
    • Ft. Worth, Texas, United States, 76104
      • Texas Pulmonary & Critical Care
    • Galveston, Texas, United States, 77555 - 0561
      • University of Texas Medical Branch at Galveston
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77024
      • *Private Practice*
    • Houston, Texas, United States, 77030
      • Houstons Veteran's Medical Center
    • Katy, Texas, United States, 77450
      • West Houston Allergy and Asthma, PA
    • New Braunfels, Texas, United States, 78130
      • Central Texas Health Research
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • San Antonio, Texas, United States, 78229
      • Wellmed Clinical Research
    • San Antonio, Texas, United States, 78229
      • Allergy and Asthma Research Center, PA
    • San Antonio, Texas, United States, 78205
      • Quality Assurance Research Centre
    • San Antonio, Texas, United States, 78229 - 4404
      • Audie L. Murphy VA Hospital
  • Vermont
    • Colchester, Vermont, United States, 05446
      • Vermont Lung Center
  • Virginia
    • Abingdon, Virginia, United States, 24210
      • Johnston Memorial Hospital Pulmonary Research
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Lynchburg, Virginia, United States, 24501
      • Lynchburg Pulmonary Associates
    • Richmond, Virginia, United States, 23249
      • Novartis Investigator Site
  • Washington
    • Bellingham, Washington, United States, 98226
      • Madrona Medical Group - Clinical Research Dept.
    • Spokane, Washington, United States, 99204
      • Pulmonary and Research Associates
    • Spokane, Washington, United States, 99216
      • William L. Gray Research
    • Tacoma, Washington, United States, 98405
      • Pulmonary Consultants, PLLC
    • Tacoma, Washington, United States, 98431
      • Madigan Army medical Center / Dept. of Army
  • West Virginia
    • Charleston, West Virginia, United States, 26304
      • Charleston Area Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Novartis Investigator 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 and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure

• Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:

  • Smoking history of at least 20 pack years
  • Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value.
  • Post-bronchodilator FEV1/FVC < 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)

Exclusion Criteria:

• Pregnant or lactating females
• Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
• Patients requiring long term oxygen therapy (> 15 h a day)
• Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)
• Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
• Patients with a history of asthma (with further criteria)
• Patients with Type I or uncontrolled Type II diabetes
• Patients with contraindications for tiotropium
• Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
• Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
• Patients with a history of long QT syndrome or whose QTc interval is prolonged
• Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures
• Patients who have had treatment with the investigational drug (with further criteria)
• Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period
• Patients with known history of non compliance to medication
• Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indacaterol 150 µg (Continued Into Stage 2); In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.	Drug: Indacaterol; In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).; Drug: Placebo to Indacaterol; In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).; Drug: Placebo to Formoterol; In the morning and in the evening, placebo to formoterol delivered via Aerolizer.
Experimental: Indacaterol 300 µg (Continued Into Stage 2); In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.	Drug: Indacaterol; In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).; Drug: Placebo to Indacaterol; In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).; Drug: Placebo to Formoterol; In the morning and in the evening, placebo to formoterol delivered via Aerolizer.
Active Comparator: Tiotropium 18 µg (Continued Into Stage 2); Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.	Drug: Tiotropium (18 µg o.d.); Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.
Placebo Comparator: Placebo (Continued Into Stage 2); In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.	Drug: Placebo to Indacaterol; In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).; Drug: Placebo to Formoterol; In the morning and in the evening, placebo to formoterol delivered via Aerolizer.
Experimental: Indacaterol 75 µg (Not Continued into Stage 2); In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.	Drug: Indacaterol; In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).; Drug: Placebo to Indacaterol; In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).; Drug: Placebo to Formoterol; In the morning and in the evening, placebo to formoterol delivered via Aerolizer.
Experimental: Indacaterol 600 µg (Not Continued Into Stage 2); In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.	Drug: Indacaterol; In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).; Drug: Placebo to Formoterol; In the morning and in the evening, placebo to formoterol delivered via Aerolizer.
Active Comparator: Formoterol 12 µg (Not Continued Into Stage 2); In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.	Drug: Placebo to Indacaterol; In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).; Drug: Formoterol (12 µg b.i.d.); Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.	after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of "Days of Poor Control" Reported Over the 26 Week Treatment Period	A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participant's diary with a score ≥2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of "days of poor control" as well as FEV1 reversibility components as covariates.	up to 26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment	Interim Analysis: Stage 1. Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.	Day 15, After 2 Weeks of treatment in Stage 1
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 1 Hour to 4 Hour Post Morning Dose After 2 Weeks of Treatment	Interim Analysis: Stage 1. Spirometry was conducted according to internationally accepted standards. Standardized with respect to time (AUC 1h-4h) for FEV1 measurements taken from 1 hour to 4 hour post morning dose on Day 14. Standardized FEV1 AUC was calculated by the trapezoidal rule. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.	Day 14, After 2 Weeks of treatment in Stage 1

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.
• Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.
• Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.
• Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13.
• Donohue JF, Fogarty C, Lotvall J, Mahler DA, Worth H, Yorgancioglu A, Iqbal A, Swales J, Owen R, Higgins M, Kramer B; INHANCE Study Investigators. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med. 2010 Jul 15;182(2):155-62. doi: 10.1164/rccm.200910-1500OC. Epub 2010 May 12.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: April 19, 2007
• First Submitted That Met QC Criteria: April 19, 2007
• First Posted (Estimate): April 20, 2007

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: indacaterol; long acting beta-2 agonist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tiotropium Bromide; Formoterol Fumarate
• Other Study ID Numbers: CQAB149B2335S