Clinical trial NCT00463567: 26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
COPD
Lung Diseases, Obstructive
Keywords: indacaterol
long acting beta-2 agonist
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 2059
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD


Eligibility criteria: 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

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: The Percentage of "Days of Poor Control" Reported Over the 26 Week Treatment Period
timeFrame: up to 26 weeks
Other outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment
timeFrame: Day 15, After 2 Weeks of treatment in Stage 1
measure: 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
timeFrame: Day 14, After 2 Weeks of treatment in Stage 1
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Homewood
country: United States
facility: Pulmonary Medicine Associates PC
state: Alabama
city: Jasper
country: United States
facility: Jasper Summit Research
state: Alabama
city: Mobile
country: United States
facility: Pulmonary Associate of Mobile, PC
state: Alabama
city: Glendale
country: United States
facility: Pulmonary Associates, PA
state: Arizona
city: Phoenix
country: United States
facility: Pulmonary Associates, PA
state: Arizona
city: Scottsdale
country: United States
facility: Novartis Investigative Center
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Pulmonary Specialists, LTD
state: Arizona
city: Tempe
country: United States
facility: Premiere Pharmaceutical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Canyon Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: SAVAHSC / Pulmonary Section
state: Arizona
city: Pine Bluff
country: United States
facility: Novartis Investigator Site
state: Arkansas
city: Buena Park
country: United States
facility: Novartis Investigator Site
state: California
city: Downey
country: United States
facility: USC Rancho Amigos Medical Center
state: California
city: Encinitas
country: United States
facility: Encompass Clinical Research - North Coast
state: California
city: Fullerton
country: United States
facility: California Research
state: California
city: Huntington Beach
country: United States
facility: Allergy and Asthma Specialists Medical Group and research Center
state: California
city: Los Alamitos
country: United States
facility: Interlink Research Institute
state: California
city: Los Angeles
country: United States
facility: Allergy Research Foundation, Inc
state: California
city: Los Angeles
country: United States
facility: Novartis Investigator Site
state: California
city: Los Angeles
country: United States
facility: Southern California Institute for Respiratory Diseases
state: California
city: Los Angeles
country: United States
facility: David Geffen UCLA School of Medicine
state: California
city: Orange
country: United States
facility: Advance Clinical Research Institute
state: California
city: Palmdale
country: United States
facility: California Allergy & Asthma Medical Group
state: California
city: Riverside
country: United States
facility: Intergrated Research Group
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Res. Center
state: California
city: Sepulveda
country: United States
facility: Greater Los Angeles Healthcare System
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Stockton
country: United States
facility: Bensch Clinical Research Associates
state: California
city: Torrance
country: United States
facility: Peninsula Pulmonary Medical Associates
state: California
city: Vista
country: United States
facility: Progressive Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clinical Research Inc
state: California
city: Boulder
country: United States
facility: Boulder Medical Center
state: Colorado
city: Denver
country: United States
facility: National Jewish Medical & Research Center
state: Colorado
city: Fort Collins
country: United States
facility: Northern Colorado Pulmonary Consultants, PC
state: Colorado
city: Golden
country: United States
facility: New West Physicians Clinical research
state: Colorado
city: Wheat Ridge
country: United States
facility: Rocky Mountain Center for Clinical Research
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research
state: Colorado
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Newark
country: United States
facility: Lung Health & Sleep Enhancement Center
state: Delaware
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
city: Jacksonville
country: United States
facility: Shands Jacksonville Medical Center
state: Florida
city: Largo
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Miami
country: United States
facility: Elite Research Institute
state: Florida
city: Pembroke Pines
country: United States
facility: Novartis Investigator Site
state: Florida
city: Pensacola
country: United States
facility: Emerald Coast Clinical Research, LLC
state: Florida
city: Pensacola
country: United States
facility: Pensacola Research Consultants
state: Florida
city: Pensacola
country: United States
facility: Integrity Research
state: Florida
city: Rockledge
country: United States
facility: Brevard Pulmonary Specialists
state: Florida
city: Sarasota
country: United States
facility: Asthma & Allergy Research Center
state: Florida
city: South Miami
country: United States
facility: South Miami Clinical Research, LLC
state: Florida
city: Tamarac
country: United States
facility: Central Medical Group, PA
state: Florida
city: Tamarac
country: United States
facility: Clireco, Inc
state: Florida
city: Tampa
country: United States
facility: Novartis Investigator Site
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Neutrotrials Research Inc
state: Georgia
city: Austell
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Marietta
country: United States
facility: Marietta Pulmonary Medicine
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates, LLC
state: Illinois
city: O'Fallon
country: United States
facility: Southern Illinois Clinical Research Center
state: Illinois
city: River Forest
country: United States
facility: Novartis Investigator Site
state: Illinois
city: Anderson
country: United States
facility: Community Hospital Anderson
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group LLC
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Iowa City
country: United States
facility: Iowa Clinical Research Corporation
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Shawnee Mission
country: United States
facility: Heart of America Research Institute
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center
state: Kansas
city: Crescent Springs
country: United States
facility: Novartis Investigator Site
state: Kentucky
city: Lexington
country: United States
facility: Kentucky Medical research Center
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Louisville
country: United States
facility: Family Asthma and Allergy Research Associates
state: Kentucky
city: Lafayette
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: Metaire
country: United States
facility: Rx R&D
state: Louisiana
city: New Orleans
country: United States
facility: LSU Health Sciences Center/LSU School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Health Sciences Center
state: Louisiana
city: Slidell
country: United States
facility: Northshore Research Associates
state: Louisiana
city: Bangor
country: United States
facility: Allergy, Asthma, Immunology, Pharmaceutical Studies
state: Maine
city: Biddeford
country: United States
facility: Primecare Physician Associates
state: Maine
city: Baltimore
country: United States
facility: John Hopkins Asthma and Allergy Center
state: Maryland
city: Brockton
country: United States
facility: Miray Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: Fallon Clinic at Worcester Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: ClinSite, Inc
state: Michigan
city: Clarkston
country: United States
facility: Novartis Investigator Site
state: Michigan
city: Detroit
country: United States
facility: Harper University Hospital; Wayne State University
state: Michigan
city: Flint
country: United States
facility: Novartis Investigator Site
state: Michigan
city: Livonia
country: United States
facility: Pulmonary Respiratory Institute of Southwest Michigan
state: Michigan
city: Port Huron
country: United States
facility: Novartis Investigator Site
state: Michigan
city: Saginaw
country: United States
facility: Synergy Medical Education Alliance
state: Michigan
city: Troy
country: United States
facility: Novartis Investigator Site
state: Michigan
city: Edina
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Minneapolis
country: United States
facility: Novartis Investigator Site
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chesterfield
country: United States
facility: St. Luke's Cardio-Pulmonary Research
state: Missouri
city: Columbia
country: United States
facility: University of Missouri - Columbia
state: Missouri
city: Kansas City
country: United States
facility: Kansas City University of Medicine and Biosciences
state: Missouri
city: Kansas City
country: United States
facility: University of Missouri KC/ Truman Medical
state: Missouri
city: St, Louis
country: United States
facility: The Clinical Research Centre
state: Missouri
city: St. Charles
country: United States
facility: Midwest Chest Consultants
state: Missouri
city: St. Louis
country: United States
facility: Washington U School of Medicine, Center for Clinical Studies
state: Missouri
city: Billings
country: United States
facility: Montana Health Research Institute
state: Montana
city: Kalispell
country: United States
facility: Novartis Investigator Site
state: Montana
city: Missoula
country: United States
facility: Novartis Investigator Site
state: Montana
city: Lincoln
country: United States
facility: Somnos Laboratories, Inc
state: Nebraska
city: Omaha
country: United States
facility: Omaha VA Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Midwest Allergy and Asthma Clinic
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Centre for Allergy, Asthma & Immunology
state: Nebraska
city: Omaha
country: United States
facility: Creigton University
state: Nebraska
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center - Pulmonary Research
state: Nebraska
city: Papillion
country: United States
facility: The Asthma & Allergy Center, PC
state: Nebraska
city: Henderson
country: United States
facility: Lovelace Scientific Resources, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Center of NV
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Cherry Hill
country: United States
facility: Delaware Valley Clinical Research
state: New Jersey
city: East Brunswick
country: United States
facility: Pulmonary and Critical Care Associates, PA
state: New Jersey
city: Newark
country: United States
facility: Novartis Investigator Site
state: New Jersey
city: Summit
country: United States
facility: Pulmonary and Allergy Associates, PA
state: New Jersey
city: Albany
country: United States
facility: Pulmonary and Critical Care Services
state: New York
city: Astoria
country: United States
facility: Crescent Medical Associates
state: New York
city: Cortland
country: United States
facility: Asthma and Allergy Associates
state: New York
city: Elmira
country: United States
facility: Asthma and Allergy Associates
state: New York
city: Massapequa
country: United States
facility: Nassau Chest Physicians, PC
state: New York
city: New Hyde Park
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: New York Pulmonary Associates, PC
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: AAIR research Centre
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Sensenbrenner Primary Care
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Shelby
country: United States
facility: Novartis Investigator Site
state: North Carolina
city: Winston Salem
country: United States
facility: Cloverdale Research Facility
state: North Carolina
city: Fargo
country: United States
facility: Merit Care Medical Group
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati VA Hospital
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Centre
state: Ohio
city: Cincinnati
country: United States
facility: Community Research Inc
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Metro Health Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University - Davis Heart and Lung Research Institute
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Marion
country: United States
facility: Novartis Investigator Site
state: Ohio
city: Sylvania
country: United States
facility: John Winder Associates
state: Ohio
city: Thornville
country: United States
facility: Advanced Health Care Specialists
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo
state: Ohio
city: Zanesville
country: United States
facility: Pharmacotherapy Research Associates, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Allergy and Asthma Clinic
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynne Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants, Inc
state: Oklahoma
city: Eugene
country: United States
facility: River Road Medical Group
state: Oregon
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Medford
country: United States
facility: Oregon Clinical Research Associates
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Portland
country: United States
facility: Novartis Investigator Site
state: Oregon
city: Beaver
country: United States
facility: Tri-State Medical Group
state: Pennsylvania
city: Easton
country: United States
facility: Novartis Investigator Site
state: Pennsylvania
city: Erie
country: United States
facility: Chest Diseases of Northwestern PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Asthma Allergy &Pulmonary Associates, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigator Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigator Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pittsburgh Pulmonary Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: South Hills Pulmonary Associates
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research
state: Rhode Island
city: Cumberland
country: United States
facility: Partners in Clinical Research
state: Rhode Island
city: Charleston
country: United States
facility: Low County Lung and Critical Care, PA
state: South Carolina
city: Charleston
country: United States
facility: Hugh D. Durrence, MD, Family Medicine
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Garden City
country: United States
facility: Med Plus South - Strand Family Practice
state: South Carolina
city: Greenville
country: United States
facility: Novartis Investigator Site
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Pharmaceutical Research
state: South Carolina
city: Varnville
country: United States
facility: Palmetto Pulmonary Medicine, PA - Sleep Disorders Lab
state: South Carolina
city: Johnson City
country: United States
facility: MultiSpeciality Clinical Research
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Center
state: Tennessee
city: Nashville
country: United States
facility: Dickson Family Medicine Group, PC
state: Tennessee
city: Nashville
country: United States
facility: Novartis Investigator Site
state: Tennessee
city: New Tazewell
country: United States
facility: Heartland Medical, P.C
state: Tennessee
city: Amarillo
country: United States
facility: PharmaTex Research LLC
state: Texas
city: Corsicana
country: United States
facility: Trinity Clinic - Corsicana
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting, Inc
state: Texas
city: Dallas
country: United States
facility: Asthma & Allergy Research Associates
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Ft. Worth
country: United States
facility: Texas Pulmonary & Critical Care
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Houston
country: United States
facility: *Private Practice*
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houstons Veteran's Medical Center
state: Texas
city: Katy
country: United States
facility: West Houston Allergy and Asthma, PA
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Quality Assurance Research Centre
state: Texas
city: San Antonio
country: United States
facility: Audie L. Murphy VA Hospital
state: Texas
city: San Antonio
country: United States
facility: Allergy and Asthma Research Center, PA
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: San Antonio
country: United States
facility: Wellmed Clinical Research
state: Texas
city: Colchester
country: United States
facility: Vermont Lung Center
state: Vermont
city: Abingdon
country: United States
facility: Johnston Memorial Hospital Pulmonary Research
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg Pulmonary Associates
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigator Site
state: Virginia
city: Bellingham
country: United States
facility: Madrona Medical Group - Clinical Research Dept.
state: Washington
city: Spokane
country: United States
facility: Pulmonary and Research Associates
state: Washington
city: Spokane
country: United States
facility: William L. Gray Research
state: Washington
city: Tacoma
country: United States
facility: Pulmonary Consultants, PLLC
state: Washington
city: Tacoma
country: United States
facility: Madigan Army medical Center / Dept. of Army
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Milwaukee
country: United States
facility: Novartis Investigator Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Novartis Investigator Site
city: Buenos Aires
country: Argentina
facility: Novartis
city: Capital Federal
country: Argentina
facility: Novartis Investigator Site
city: Santa Fe
country: Argentina
facility: Novartis Investigator Site
city: Ajax
country: Canada
facility: Novartis Investigator Site
city: Calgary
country: Canada
facility: Novartis Investigator Site
city: Chatham
country: Canada
facility: Novartis Investigator Site
city: Gatineau
country: Canada
facility: Novartis Investigator Site
city: Moncton
country: Canada
facility: Novartis Investigator Site
city: Montreal
country: Canada
facility: Novartis Investigator Site
city: Niagara Falls
country: Canada
facility: Novartis Investigator Site
city: Ottawa
country: Canada
facility: Novartis Investigator Site
city: Quebec
country: Canada
facility: Novartis
city: Saskatoon
country: Canada
facility: Novartis Investigator Site
city: Sherbrooke
country: Canada
facility: Novartis Investigator Site
city: St John's
country: Canada
facility: Novartis Investigator Site
city: St John
country: Canada
facility: Novartis Investigator Site
city: St Romuald
country: Canada
facility: Novartis Investigator Site
city: Ste-Foy
country: Canada
facility: Novartis Investigator Site
city: Toronto
country: Canada
facility: Novartis Investigator Site
city: Trois-Rivieres
country: Canada
facility: Novartis Investigator Site
city: Vancouver
country: Canada
facility: Novartis Investigator Site
city: Waterloo
country: Canada
facility: Novartis Investigator Site
city: Windsor
country: Canada
facility: Novartis Investigator Site
city: Winnipeg
country: Canada
facility: Novartis Investigator Site
city: Augsburg
country: Germany
facility: Novartis Investigator Site
city: Bad Segeberg
country: Germany
facility: Novartis Investigator Site
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Bielefeld
country: Germany
facility: Novartis Investigator Site
city: Bonn
country: Germany
facility: Novartis Investigator Site
city: Bruhl
country: Germany
facility: Novartis Investigator Site
city: Dachau
country: Germany
facility: Novartis Investigator Site
city: Fuerth
country: Germany
facility: Novartis
city: Hamburg
country: Germany
facility: Novartis Investigator Site
city: Hoyerswerda
country: Germany
facility: Novartis Investigator Site
city: Kaufbeuren
country: Germany
facility: Novartis Investigator Site
city: Landsberg
country: Germany
facility: Novartis Investigator Site
city: Leipzig
country: Germany
facility: Novartis Investigator Site
city: Mainz
country: Germany
facility: Novartis Investigator Site
city: Muenchen
country: Germany
facility: Novartis Investigator Site
city: Oranienburg
country: Germany
facility: Novartis Investigator Site
city: Oschersleben
country: Germany
facility: Novartis Investigator Site
city: Potsdam
country: Germany
facility: Novartis Investigator Site
city: Ratingen
country: Germany
facility: Novartis Investigator Site
city: Steinfurt
country: Germany
facility: Novartis Investigator Site
city: Wuppertal
country: Germany
facility: Novartis Investigator Site
city: Bangalore
country: India
facility: Novartis Investigator Site
city: Banglore
country: India
facility: Novartis Investigator Site
city: Caranazalem
country: India
facility: Novartis Investigator Site
city: Chennai
country: India
facility: Novartis Investigator Site
city: Coimbatore
country: India
facility: Novartis Investigator Site
city: Hyderabaad
country: India
facility: Novartis Investigator Site
city: Indore
country: India
facility: Novartis Investigator Site
city: Jaipur
country: India
facility: Novartis Investigator Site
city: Kolkatta
country: India
facility: Novartis Investigator Site
city: Ludhiana
country: India
facility: Novartis Investigator Site
city: Mumbai
country: India
facility: Novartis Investigator Site
city: Trivandrum
country: India
facility: Novartis Investigator Site
city: Bologna
country: Italy
facility: Novartis Investigator Site
city: Busto Arsizio
country: Italy
facility: Novartis Investigator Site
city: Catania
country: Italy
facility: Novartis Investigator Site
city: Catanzaro
country: Italy
facility: Novartis Investigator Site
city: Chioggia
country: Italy
facility: Novartis Investigator Site
city: Crema
country: Italy
facility: Novartis Investigator Site
city: Ferrara
country: Italy
facility: Novartis Investigator Site
city: Firenze
country: Italy
facility: Novartis Investigator Site
city: Genova
country: Italy
facility: Novartis Investigator Site
city: Messina
country: Italy
facility: Novartis Investigator Site
city: Milano
country: Italy
facility: Novartis Investigator Site
city: Milano
country: Italy
facility: Novartis
city: Pisa
country: Italy
facility: Novartis Investigator Site
city: Roma
country: Italy
facility: Novartis Investigator Site
city: Rozzano
country: Italy
facility: Novartis Investigator Site
city: Siena
country: Italy
facility: Novartis Investigator Site
city: Bucheon
country: Korea, Republic of
facility: Novartis Investigator Site
city: Busan
country: Korea, Republic of
facility: Novartis Investigator Site
city: Chuncheon
country: Korea, Republic of
facility: Novartis Investigator Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigator Site
city: Kwangju
country: Korea, Republic of
facility: Novartis Investigator Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigator Site
city: Seoul
country: Korea, Republic of
facility: Novartis
city: Suwon
country: Korea, Republic of
facility: Novartis Investigator Site
city: Wonju
country: Korea, Republic of
facility: Novartis Investigator Site
city: Ponce
country: Puerto Rico
facility: Novartis Investigator Site
city: Alicante
country: Spain
facility: Novartis Investigator Site
city: Barcelona
country: Spain
facility: Novartis Investigator Site
city: Barcelona
country: Spain
facility: Novartis
city: Burgos
country: Spain
facility: Novartis Investigator Site
city: Cadiz
country: Spain
facility: Novartis Investigator Site
city: Calde Lugo
country: Spain
facility: Novartis Investigator Site
city: Galdakano
country: Spain
facility: Novartis Investigator Site
city: Gerona
country: Spain
facility: Novartis Investigator Site
city: Gran Canaria
country: Spain
facility: Novartis Investigator Site
city: La Coruna
country: Spain
facility: Novartis Investigator Site
city: Madrid
country: Spain
facility: Novartis Investigator Site
city: Malaga
country: Spain
facility: Novartis Investigator Site
city: Orense
country: Spain
facility: Novartis Investigator Site
city: Oviedo
country: Spain
facility: Novartis Investigator Site
city: Palma de Mallorca
country: Spain
facility: Novartis Investigator Site
city: Ponferrada
country: Spain
facility: Novartis Investigator Site
city: Pontevedra
country: Spain
facility: Novartis Investigator Site
city: Puerto de Sagunto
country: Spain
facility: Novartis Investigator Site
city: Sevilla
country: Spain
facility: Novartis Investigator Site
city: Valencia
country: Spain
facility: Novartis Investigator Site
city: Vic
country: Spain
facility: Novartis Investigator Site
city: Vila-Real
country: Spain
facility: Novartis Investigator Site
city: Zaragoza
country: Spain
facility: Novartis Investigator Site
city: Goteborg
country: Sweden
facility: Novartis
city: Jonkoping
country: Sweden
facility: Novartis Investigator Site
city: Lidingo
country: Sweden
facility: Novartis Investigator Site
city: Lulea
country: Sweden
facility: Novartis Investigator Site
city: Lund
country: Sweden
facility: Novartis Investigator Site
city: Chiayi
country: Taiwan
facility: Novartis Investigator Site
city: LinKou
country: Taiwan
facility: Novartis Investigator Site
city: Taichung
country: Taiwan
facility: Novartis Investigator Site
city: Taipei
country: Taiwan
facility: Novartis Investigator Site
city: Taipei
country: Taiwan
facility: Novartis
city: Anakara
country: Turkey
facility: Novartis Investigator Site
city: Istanbul
country: Turkey
facility: Novartis
city: Izmir
country: Turkey
facility: Novartis Investigator Site
city: Konya
country: Turkey
facility: Novartis Investigator Site
city: Manisa
country: Turkey
facility: Novartis Investigator Site
city: Mersin
country: Turkey
facility: Novartis Investigator Site
city: Yenisehir
country: Turkey
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.