AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 2/3NCT00463567

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

A Phase 2/3 study testing Indacaterol, Formoterol (12 µg b.i.d.) and Tiotropium (18 µg o.d.) in people with Pulmonary Disease, Chronic Obstructive and COPD, run by Novartis at 344 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Indacaterol, Formoterol (12 µg b.i.d.) and Tiotropium (18 µg o.d.)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,059 participants
Where
344 sitesin 12 countries
Study dates
Apr 2007to Aug 2008
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

344 sites in 12 countries.

344 sites in 12 countries

United States221 sites

  • Johnston Memorial Hospital Pulmonary Research

    Abingdon, Virginia, 24210

  • Pulmonary and Critical Care Services

    Albany, New York, 12205

  • PharmaTex Research LLC

    Amarillo, Texas, 79106

  • Community Hospital Anderson

    Anderson, Indiana, 46011

  • ClinSite, Inc

    Ann Arbor, Michigan, 48106-0525

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • Crescent Medical Associates

    Astoria, New York, 11102

  • Neutrotrials Research Inc

    Atlanta, Georgia, 30342

  • Georgia Clinical Research

    Austell, Georgia, 30106

  • John Hopkins Asthma and Allergy Center

    Baltimore, Maryland, 21224

  • Allergy, Asthma, Immunology, Pharmaceutical Studies

    Bangor, Maine, 04401

  • Tri-State Medical Group

    Beaver, Pennsylvania, 15009 - 1957

  • Madrona Medical Group - Clinical Research Dept.

    Bellingham, Washington, 98226

  • Primecare Physician Associates

    Biddeford, Maine, 04005

  • Montana Health Research Institute

    Billings, Montana, 59102

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Boulder Medical Center

    Boulder, Colorado, 80304

  • Miray Medical Center

    Brockton, Massachusetts, 02302

  • Novartis Investigator Site

    Buena Park, California, 90620

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Low County Lung and Critical Care, PA

    Charleston, South Carolina, 29406-7108

  • Hugh D. Durrence, MD, Family Medicine

    Charleston, South Carolina, 29412

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Charleston Area Medical Center

    Charleston, West Virginia, 26304

  • Sensenbrenner Primary Care

    Charlotte, North Carolina, 28277

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Delaware Valley Clinical Research

    Cherry Hill, New Jersey, 08003

  • St. Luke's Cardio-Pulmonary Research

    Chesterfield, Missouri, 63017

  • University of Chicago Hospital

    Chicago, Illinois, 60637

  • Cincinnati VA Hospital

    Cincinnati, Ohio, 45220

  • New Horizons Clinical Research

    Cincinnati, Ohio, 452242

  • Bernstein Clinical Research Centre

    Cincinnati, Ohio, 45231

  • Community Research Inc

    Cincinnati, Ohio, 45245

  • Novartis Investigator Site

    Clarkston, Michigan, 48346

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Metro Health Medical Center

    Cleveland, Ohio, 44109-1998

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Vermont Lung Center

    Colchester, Vermont, 05446

  • University of Missouri - Columbia

    Columbia, Missouri, 65212

  • Ohio State University - Davis Heart and Lung Research Institute

    Columbus, Ohio, 43210

  • Novartis Investigator Site

    Columbus, Ohio, 43213

  • Remington-Davis Clinical Research

    Columbus, Ohio, 43215

  • Novartis Investigator Site

    Columbus, Ohio, 43235

  • Trinity Clinic - Corsicana

    Corsicana, Texas, 75110

  • Asthma and Allergy Associates

    Cortland, New York, 13045

  • New England Center for Clinical Research

    Cranston, Rhode Island, 02920

  • Novartis Investigator Site

    Crescent Springs, Kentucky, 41017

  • Partners in Clinical Research

    Cumberland, Rhode Island, 02864

  • Pharmaceutical Research & Consulting, Inc

    Dallas, Texas, 75231-4307

  • Asthma & Allergy Research Associates

    Dallas, Texas, 75231

  • National Jewish Medical & Research Center

    Denver, Colorado, 80206

  • Harper University Hospital; Wayne State University

    Detroit, Michigan, 48201

  • USC Rancho Amigos Medical Center

    Downey, California, 90242

  • Pulmonary and Critical Care Associates, PA

    East Brunswick, New Jersey, 08816

  • Novartis Investigator Site

    Easton, Pennsylvania, 18045

  • Minnesota Lung Center

    Edina, Minnesota, 55435

  • Western Sky Medical Research

    El Paso, Texas, 79902

  • Asthma and Allergy Associates

    Elmira, New York, 14905

  • Encompass Clinical Research - North Coast

    Encinitas, California, 92024

  • Chest Diseases of Northwestern PA

    Erie, Pennsylvania, 16506

  • River Road Medical Group

    Eugene, Oregon, 97404

  • Merit Care Medical Group

    Fargo, North Dakota, 58122

  • Novartis Investigator Site

    Flint, Michigan, 48532

  • Northern Colorado Pulmonary Consultants, PC

    Fort Collins, Colorado, 80528

  • Texas Pulmonary & Critical Care

    Fort Worth, Texas, 76104

  • California Research

    Fullerton, California, 92835

  • University of Florida Shands Hospital

    Gainesville, Florida, 32610 - 0277

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555 - 0561

  • Med Plus South - Strand Family Practice

    Garden City, South Carolina, 29576

  • Pulmonary Associates, PA

    Glendale, Arizona, 85306

  • New West Physicians Clinical research

    Golden, Colorado, 80401

  • Novartis Investigator Site

    Greenville, South Carolina, 29615

  • Lovelace Scientific Resources, Inc.

    Henderson, Nevada, 89014

  • Pulmonary Medicine Associates PC

    Homewood, Alabama, 35209

  • *Private Practice*

    Houston, Texas, 77024

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houstons Veteran's Medical Center

    Houston, Texas, 77030

  • Allergy and Asthma Specialists Medical Group and research Center

    Huntington Beach, California, 92647

  • Dawes Fretzin Clinical Research Group LLC

    Indianapolis, Indiana, 46256

  • Iowa Clinical Research Corporation

    Iowa City, Iowa, 52240

  • University of Iowa

    Iowa City, Iowa, 52242

  • Shands Jacksonville Medical Center

    Jacksonville, Florida, 32209

  • Jasper Summit Research

    Jasper, Alabama, 35501

  • MultiSpeciality Clinical Research

    Johnson City, Tennessee, 37601

  • Novartis Investigator Site

    Kalispell, Montana, 59901

  • Kansas City University of Medicine and Biosciences

    Kansas City, Missouri, 64106 - 1453

  • University of Missouri KC/ Truman Medical

    Kansas City, Missouri, 64108-2677

  • West Houston Allergy and Asthma, PA

    Katy, Texas, 77450

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Volunteer Research Center

    Knoxville, Tennessee, 37920

  • Gulf Coast Research, LLC

    Lafayette, Louisiana, 70503

  • Innovative Research of West Florida

    Largo, Florida, 33770

  • Clinical Research Center of NV

    Las Vegas, Nevada, 89131

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Kentucky Medical research Center

    Lexington, Kentucky, 40504

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • Somnos Laboratories, Inc

    Lincoln, Nebraska, 68510

  • Pulmonary Respiratory Institute of Southwest Michigan

    Livonia, Michigan, 48152

  • Interlink Research Institute

    Los Alamitos, California, 90720

  • Allergy Research Foundation, Inc

    Los Angeles, California, 90025

  • Novartis Investigator Site

    Los Angeles, California, 90033

  • Southern California Institute for Respiratory Diseases

    Los Angeles, California, 90048

  • David Geffen UCLA School of Medicine

    Los Angeles, California, 90095

  • Family Asthma and Allergy Research Associates

    Louisville, Kentucky, 40215

  • Lynchburg Pulmonary Associates

    Lynchburg, Virginia, 24501

  • Marietta Pulmonary Medicine

    Marietta, Georgia, 30060

  • Novartis Investigator Site

    Marion, Ohio, 43302

  • Nassau Chest Physicians, PC

    Massapequa, New York, 11758

  • Clinical Research Institute of Southern Oregon, PC

    Medford, Oregon, 97504

  • Oregon Clinical Research Associates

    Medford, Oregon, 97504

  • Rx R&D

    Metaire, Louisiana, 70002

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Elite Research Institute

    Miami, Florida, 33169

  • Novartis Investigator Site

    Milwaukee, Wisconsin, 53209

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Novartis Investigator Site

    Minneapolis, Minnesota, 55402

  • Minnesota Lung Center

    Minneapolis, Minnesota, 55407

  • Novartis Investigator Site

    Missoula, Montana, 59808

  • Pulmonary Associate of Mobile, PC

    Mobile, Alabama, 36608

  • Dickson Family Medicine Group, PC

    Nashville, Tennessee, 37203

  • Novartis Investigator Site

    Nashville, Tennessee, 37208-3599

  • Central Texas Health Research

    New Braunfels, Texas, 78130

  • North Shore University Hospital

    New Hyde Park, New York, 11040

  • LSU Health Sciences Center/LSU School of Medicine

    New Orleans, Louisiana, 70112

  • New Orleans Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Heartland Medical, P.C

    New Tazewell, Tennessee, 37825-1409

  • New York Pulmonary Associates, PC

    New York, New York, 10016

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Lung Health & Sleep Enhancement Center

    Newark, Delaware, 19713

  • Novartis Investigator Site

    Newark, New Jersey, 7101

  • Sneeze, Wheeze & Itch Associates, LLC

    Normal, Illinois, 61761

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Southern Illinois Clinical Research Center

    O'Fallon, Illinois, 62269

  • Oklahoma Allergy and Asthma Clinic

    Oklahoma City, Oklahoma, 73104

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

  • Lynne Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Omaha VA Medical Center

    Omaha, Nebraska, 68105

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Midwest Allergy and Asthma Clinic

    Omaha, Nebraska, 68130

  • Creighton University Centre for Allergy, Asthma & Immunology

    Omaha, Nebraska, 68131

  • Creigton University

    Omaha, Nebraska, 68131

  • Heartland Clinical Research, Inc

    Omaha, Nebraska, 68134

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • University of Nebraska Medical Center - Pulmonary Research

    Omaha, Nebraska, 68198 - 5885

  • Advance Clinical Research Institute

    Orange, California, 92869

  • California Allergy & Asthma Medical Group

    Palmdale, California, 93551

  • The Asthma & Allergy Center, PC

    Papillion, Nebraska, 68046

  • Novartis Investigator Site

    Pembroke Pines, Florida, 33029

  • Emerald Coast Clinical Research, LLC

    Pensacola, Florida, 32504

  • Pensacola Research Consultants

    Pensacola, Florida, 32504

  • Integrity Research

    Pensacola, Florida, 32514

  • Asthma Allergy &Pulmonary Associates, PC

    Philadelphia, Pennsylvania, 19107

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19107

  • Novartis Investigator Site

    Philadelphia, Pennsylvania, 19140

  • Novartis Investigator Site

    Philadelphia, Pennsylvania, 19141

  • Pulmonary Associates, PA

    Phoenix, Arizona, 85006

  • Novartis Investigator Site

    Pine Bluff, Arkansas, 71603

  • Pittsburgh Pulmonary Associates

    Pittsburgh, Pennsylvania, 15025

  • South Hills Pulmonary Associates

    Pittsburgh, Pennsylvania, 15243

  • Novartis Investigator Site

    Port Huron, Michigan, 48060

  • Allergy Associates Research Center

    Portland, Oregon, 97213

  • Novartis Investigator Site

    Portland, Oregon, 97227-1110

  • North Carolina Clinical Research

    Raleigh, North Carolina, 27607

  • Novartis Investigator Site

    Richmond, Virginia, 23249

  • Novartis Investigator Site

    River Forest, Illinois, 60305

  • Intergrated Research Group

    Riverside, California, 92506

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • AAIR research Centre

    Rochester, New York, 14618

  • Brevard Pulmonary Specialists

    Rockledge, Florida, 32955

  • Synergy Medical Education Alliance

    Saginaw, Michigan, 48602 - 5303

  • Midwest Chest Consultants

    Saint Charles, Missouri, 63301

  • Quality Assurance Research Centre

    San Antonio, Texas, 78205

  • Audie L. Murphy VA Hospital

    San Antonio, Texas, 78229 - 4404

  • Allergy and Asthma Research Center, PA

    San Antonio, Texas, 78229

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Wellmed Clinical Research

    San Antonio, Texas, 78229

  • Allergy & Asthma Associates of Santa Clara Res. Center

    San Jose, California, 95117

  • Asthma & Allergy Research Center

    Sarasota, Florida, 34233

  • Novartis Investigative Center

    Scottsdale, Arizona, 85255

  • Arizona Pulmonary Specialists, LTD

    Scottsdale, Arizona, 85258

  • Greater Los Angeles Healthcare System

    Sepulveda, California, 91343

  • Heart of America Research Institute

    Shawnee Mission, Kansas, 66216

  • Novartis Investigator Site

    Shelby, North Carolina, 28150

  • Louisiana Health Sciences Center

    Shreveport, Louisiana, 71103

  • Northshore Research Associates

    Slidell, Louisiana, 70461

  • South Bend Clinic

    South Bend, Indiana, 46617

  • South Miami Clinical Research, LLC

    South Miami, Florida, 33143

  • Spartanburg Pharmaceutical Research

    Spartanburg, South Carolina, 29303

  • Pulmonary and Research Associates

    Spokane, Washington, 99204

  • William L. Gray Research

    Spokane, Washington, 99216

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Washington U School of Medicine, Center for Clinical Studies

    St Louis, Missouri, 63110

  • The Clinical Research Centre

    St Louis, Missouri, 63141

  • Bensch Clinical Research Associates

    Stockton, California, 95207

  • Pulmonary and Allergy Associates, PA

    Summit, New Jersey, 07901

  • John Winder Associates

    Sylvania, Ohio, 43650

  • Pulmonary Consultants, PLLC

    Tacoma, Washington, 98405

  • Madigan Army medical Center / Dept. of Army

    Tacoma, Washington, 98431

  • Central Medical Group, PA

    Tamarac, Florida, 33321

  • Clireco, Inc

    Tamarac, Florida, 33321

  • Novartis Investigator Site

    Tampa, Florida, 33603

  • University of South Florida

    Tampa, Florida, 33613

  • Premiere Pharmaceutical Research, LLC

    Tempe, Arizona, 85282

  • Advanced Health Care Specialists

    Thornville, Ohio, 43076

  • The University of Toledo

    Toledo, Ohio, 43614

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Peninsula Pulmonary Medical Associates

    Torrance, California, 90505

  • Novartis Investigator Site

    Troy, Michigan, 48085

  • Canyon Clinical Research, LLC

    Tucson, Arizona, 85712

  • SAVAHSC / Pulmonary Section

    Tucson, Arizona, 85723

  • Healthcare Research Consultants, Inc

    Tulsa, Oklahoma, 74135

  • Palmetto Pulmonary Medicine, PA - Sleep Disorders Lab

    Varnville, South Carolina, 29944

  • Progressive Clinical Research

    Vista, California, 92083

  • Allergy and Asthma Clinical Research Inc

    Walnut Creek, California, 94598

  • Rocky Mountain Center for Clinical Research

    Wheat Ridge, Colorado, 80033

  • Western States Clinical Research

    Wheat Ridge, Colorado, 80033

  • Cloverdale Research Facility

    Winston-Salem, North Carolina, 27103

  • Fallon Clinic at Worcester Medical Center

    Worcester, Massachusetts, 01604

  • Pharmacotherapy Research Associates, Inc

    Zanesville, Ohio, 43701

Other trials in United States

Spain23 sites

  • Novartis Investigator Site

    A Coruña

  • Novartis Investigator Site

    Alicante

  • Novartis Investigator Site

    Barcelona

  • Novartis

    Barcelona

  • Novartis Investigator Site

    Burgos

  • Novartis Investigator Site

    Cadiz

  • Novartis Investigator Site

    Calde Lugo

  • Novartis Investigator Site

    Galdakano

  • Novartis Investigator Site

    Girona

  • Novartis Investigator Site

    Gran Canaria

  • Novartis Investigator Site

    Madrid

  • Novartis Investigator Site

    Málaga

  • Novartis Investigator Site

    Ourense

  • Novartis Investigator Site

    Oviedo

  • Novartis Investigator Site

    Palma de Mallorca

  • Novartis Investigator Site

    Ponferrada

  • Novartis Investigator Site

    Pontevedra

  • Novartis Investigator Site

    Port de Sagunt

  • Novartis Investigator Site

    Seville

  • Novartis Investigator Site

    Valencia

  • Novartis Investigator Site

    Vic

  • Novartis Investigator Site

    Vila-real

  • Novartis Investigator Site

    Zaragoza

Other trials in Spain

Germany21 sites

  • Novartis Investigator Site

    Augsburg

  • Novartis Investigator Site

    Bad Segeberg

  • Novartis Investigator Site

    Berlin

  • Novartis Investigator Site

    Bielefeld

  • Novartis Investigator Site

    Bonn

  • Novartis Investigator Site

    Brühl

  • Novartis Investigator Site

    Dachau

  • Novartis

    Fürth

  • Novartis Investigator Site

    Hamburg

  • Novartis Investigator Site

    Hoyerswerda

  • Novartis Investigator Site

    Kaufbeuren

  • Novartis Investigator Site

    Landsberg

  • Novartis Investigator Site

    Leipzig

  • Novartis Investigator Site

    Mainz

  • Novartis Investigator Site

    München

  • Novartis Investigator Site

    Oranienburg

  • Novartis Investigator Site

    Oschersleben

  • Novartis Investigator Site

    Potsdam

  • Novartis Investigator Site

    Ratingen

  • Novartis Investigator Site

    Steinfurt

  • Novartis Investigator Site

    Wuppertal

Other trials in Germany

Canada20 sites

  • Novartis Investigator Site

    Ajax

  • Novartis Investigator Site

    Calgary

  • Novartis Investigator Site

    Chatham

  • Novartis Investigator Site

    Gatineau

  • Novartis Investigator Site

    Moncton

  • Novartis Investigator Site

    Montreal

  • Novartis Investigator Site

    Niagara Falls

  • Novartis Investigator Site

    Ottawa

  • Novartis

    Québec

  • Novartis Investigator Site

    Saint Romuald

  • Novartis Investigator Site

    Saskatoon

  • Novartis Investigator Site

    Sherbrooke

  • Novartis Investigator Site

    St. John's

  • Novartis Investigator Site

    Ste-Foy

  • Novartis Investigator Site

    Toronto

  • Novartis Investigator Site

    Trois-Rivières

  • Novartis Investigator Site

    Vancouver

  • Novartis Investigator Site

    Waterloo

  • Novartis Investigator Site

    Windsor

  • Novartis Investigator Site

    Winnipeg

Other trials in Canada

Italy16 sites

  • Novartis Investigator Site

    Bologna

  • Novartis Investigator Site

    Busto Arsizio

  • Novartis Investigator Site

    Catania

  • Novartis Investigator Site

    Catanzaro

  • Novartis Investigator Site

    Chioggia

  • Novartis Investigator Site

    Crema

  • Novartis Investigator Site

    Ferrara

  • Novartis Investigator Site

    Florence

  • Novartis Investigator Site

    Genova

  • Novartis Investigator Site

    Messina

  • Novartis Investigator Site

    Milan

  • Novartis

    Milan

  • Novartis Investigator Site

    Pisa

  • Novartis Investigator Site

    Roma

  • Novartis Investigator Site

    Rozzano

  • Novartis Investigator Site

    Siena

Other trials in Italy

India12 sites

  • Novartis Investigator Site

    Bangalore

  • Novartis Investigator Site

    Banglore

  • Novartis Investigator Site

    Caranazalem

  • Novartis Investigator Site

    Chennai

  • Novartis Investigator Site

    Coimbatore

  • Novartis Investigator Site

    Hyderabaad

  • Novartis Investigator Site

    Indore

  • Novartis Investigator Site

    Jaipur

  • Novartis Investigator Site

    Kolkata

  • Novartis Investigator Site

    Ludhiana

  • Novartis Investigator Site

    Mumbai

  • Novartis Investigator Site

    Trivandrum

Other trials in India

South Korea9 sites

  • Novartis Investigator Site

    Bucheon-si

  • Novartis Investigator Site

    Busan

  • Novartis Investigator Site

    Chuncheon

  • Novartis Investigator Site

    Daegu

  • Novartis Investigator Site

    Kwangju

  • Novartis Investigator Site

    Seoul

  • Novartis

    Seoul

  • Novartis Investigator Site

    Suwon

  • Novartis Investigator Site

    Wŏnju

Other trials in South Korea

Turkey (Türkiye)7 sites

  • Novartis Investigator Site

    Ankara

  • Novartis

    Istanbul

  • Novartis Investigator Site

    Izmir

  • Novartis Investigator Site

    Konya

  • Novartis Investigator Site

    Manisa

  • Novartis Investigator Site

    Mersin

  • Novartis Investigator Site

    Yenişehir

Other trials in Turkey (Türkiye)

Sweden5 sites

  • Novartis

    Gothenburg

  • Novartis Investigator Site

    Jönköping

  • Novartis Investigator Site

    Lidingö

  • Novartis Investigator Site

    Luleå

  • Novartis Investigator Site

    Lund

Other trials in Sweden

Taiwan5 sites

  • Novartis Investigator Site

    Chiayi City

  • Novartis Investigator Site

    Linkou District

  • Novartis Investigator Site

    Taichung

  • Novartis Investigator Site

    Taipei

  • Novartis

    Taipei

Other trials in Taiwan

Argentina4 sites

  • Novartis Investigator Site

    Buenos Aires

  • Novartis

    Buenos Aires

  • Novartis Investigator Site

    Capital Federal

  • Novartis Investigator Site

    Santa Fe

Other trials in Argentina

Puerto Rico1 site

  • Novartis Investigator Site

    Ponce, 716

Other trials in Puerto Rico

About this study

Official title: 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

Being tested
Indacaterol, Formoterol (12 µg b.i.d.), Tiotropium (18 µg o.d.), Placebo to Indacaterol, Placebo to Formoterol
Keywords
indacaterol, long acting beta-2 agonist
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IndacaterolDrug

    In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).

  • Formoterol (12 µg b.i.d.)Drug

    Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.

  • Tiotropium (18 µg o.d.)Drug

    Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.

  • Placebo to IndacaterolDrug

    In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).

  • Placebo to FormoterolDrug

    In the morning and in the evening, placebo to formoterol delivered via Aerolizer.

Study groups in NCT00463567
Study groupRoleWhat they receive
Indacaterol 150 µg (Continued Into Stage 2)ExperimentalIn 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.
Receives: Drug: Indacaterol; Drug: Placebo to Indacaterol; Drug: Placebo to Formoterol
Indacaterol 300 µg (Continued Into Stage 2)ExperimentalIn 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.
Receives: Drug: Indacaterol; Drug: Placebo to Indacaterol; Drug: Placebo to Formoterol
Tiotropium 18 µg (Continued Into Stage 2)Active comparatorTiotropium 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.
Receives: Drug: Tiotropium (18 µg o.d.)
Placebo (Continued Into Stage 2)Placebo comparatorIn 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.
Receives: Drug: Placebo to Indacaterol; Drug: Placebo to Formoterol
Indacaterol 75 µg (Not Continued into Stage 2)ExperimentalIn 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.
Receives: Drug: Indacaterol; Drug: Placebo to Indacaterol; Drug: Placebo to Formoterol
Indacaterol 600 µg (Not Continued Into Stage 2)ExperimentalIn 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.
Receives: Drug: Indacaterol; Drug: Placebo to Formoterol
Formoterol 12 µg (Not Continued Into Stage 2)Active comparatorIn 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.
Receives: Drug: Formoterol (12 µg b.i.d.); Drug: Placebo to Indacaterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: after 12 weeks of treatment

Secondary outcomes (1)

  1. 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.

    Measured: up to 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionAug 2008
  4. Study completionAug 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,059 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00463567
Sponsor's protocol ID
CQAB149B2335S
Status last verified
Jul 2011
First submitted
19 Apr 2007
Last updated
18 Aug 2011

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.

    PubMed 22206353

  • 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.

    PubMed 22158330

  • 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.

    PubMed 21397482

  • 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.

    PubMed 21227674

  • 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.

    PubMed 20463178

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Indacaterol, Formoterol (12 µg b.i.d.) and Tiotropium (18 µg o.d.) in people with Pulmonary Disease, Chronic Obstructive and COPD, run by Novartis at 344 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 344 sites in United States, Spain, Germany, Canada, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment (time frame: after 12 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00463567, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2011.

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