Clinical Trials

Sponsor(s): Novartis Pharmaceuticals

Condition(s):

Chronic Obstructive Pulmonary Disease (COPD)
Lung Disease
Chronic Obstructive Lung Disease
COPD

Purpose: This study will assess efficacy and safety of indacaterol (150 µg once daily [o.d.]) when combined with tiotropium (18 µg o.d.) versus tiotropium (18 µg o.d.) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

Eligibility:

Minimum Age:

40 Years

Accepts Healthy Volunteers:

No

Inclusion Criteria:

- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for
Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and smoking history of at
least 10 pack-years

Exclusion Criteria:

- Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid
treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or
during the run in period

- Patients who have had a respiratory tract infection within 6 weeks prior to screening
or during the run-in period

- Patients with body mass index less than 15 or more than 40 kg/m2

- Patients with concomitant pulmonary disease

- Patients with a history of asthma

- Patients with diabetes Type I or uncontrolled diabetes Type II

- Any patient with lung cancer or a history of lung cancer

- Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply

Other Location(s): Birmingham, Alabama United States,Mobile, Alabama United States,Tucson, Arizona United States,Scottsdale, Arizona United States,Tucson, Arizona United States,Pine Bluff, Arkansas United States,Stockton, California United States,Los Angeles, California United States,Temecula, California United States,Long Beach, California United States,Fountain Valley, California United States,Palmdale, California United States,National City, California United States,Hartford, Connecticut United States,Miami, Florida United States,Miami, Florida United States,Naranja, Florida United States,Clearwater, Florida United States,Sarasota, Florida United States,Ft. Walton Beach, Florida United States,Pensacola, Florida United States,Atlanta, Georgia United States,Conyers, Georgia United States,Normal, Illinois United States,Iowa City, Iowa United States,Lenexa, Kansas United States,Kansas City, Kansas United States,Topeka, Kansas United States,Topeka, Kansas United States,Lafayette, Louisiana United States,Slidell, Louisiana United States,Metaire, Louisiana United States,New Orleans, Louisiana United States,Columbia, Maryland United States,Brockton, Massachusetts United States,Clarkston, Michigan United States,Detroit, Michigan United States,St Charles, Missouri United States,Missoula, Montana United States,Omaha, Nebraska United States,Omaha, Nebraska United States,Boys Town, Nebraska United States,Las Vegas, Nevada United States,Lebanon, New Hampshire United States,Asbury Park, New Jersey United States,Rochester, New York United States,Winston-Salem, North Carolina United States,Mooresville, North Carolina United States,Tulsa, Oklahoma United States,Medford, Oregon United States,Bethlehem, Pennsylvania United States,Cumberland, Rhode Island United States,Spartanburg, South Carolina United States,Greenville, South Carolina United States,Knoxville, Tennessee United States,Houston, Texas United States,New Braunfels, Texas United States,Houston, Texas United States,El Paso, Texas United States,Richmond, Virginia United States,Richmond, Virginia United States,Newport News, Virginia United States,Buenos Aires, Argentina,Mendoza, Argentina,Mendoza, Argentina,Rosario, Argentina,Corrientes, Argentina,Cordoba, Argentina,Glebe, Australia,KOGARAH, Australia,GARRAN, Australia,Box Hill, Australia,Clayton, Australia,Nedlands, Australia,Bogota, Colombia,Barranquilla, Colombia,Bogota, Colombia,Medellin, Colombia,Soeborg, Denmark,Fredericia, Denmark,Vejle, Denmark,Silkeborg, Denmark,Copenhagen, Denmark,Cottbus, Germany,Leipzig, Germany,Berlin, Germany,Straussberg, Germany,Potsdam, Germany,Rostock, Germany,Grosshansdorf, Germany,Hannover, Germany,Neuss, Germany,Wuppertal, Germany,Dortmund, Germany,Mainz, Germany,Frankfurt, Germany,Gelnhausen, Germany,Wiesbaden, Germany,Schwetzingen, Germany,Heidelberg, Germany,Neu-Ulm, Germany,Schwabach, Germany,Donaustauf, Germany,Erfurt, Germany,Guatemala, Guatemala,Guatemala City, Guatemala,Mexico City, Mexico,Guadalajara, Mexico,Zapopan, Mexico,Monterrey, Mexico,Manila, Philippines,Midrand, South Africa,Johannesburg, South Africa,Amanzimtoti, South Africa,Umkomaas, South Africa,Cape Town, South Africa,Alicante, Spain,Granollers, Spain,Barcelona, Spain,Cadiz, Spain,La Coruna, Spain,Jaén, Spain,Leon, Spain,Begonte, Spain,Madrid, Spain,Pamplona, Spain,Vigo, Spain,Torrelavega, Spain,Valencia, Spain,Antalya, Turkey,Canakkale, Turkey,Isparta, Turkey,Istanbul, Turkey,Mecidiyekoy/Istanbul, Turkey,ISTANBUL, Turkey,Kartal, Turkey,Yenisehir/Izmir, Turkey,Kayseri, Turkey,Malatya, Turkey,Manisa, Turkey,Kozlu / Zonguldak, Turkey

Terms: This is an abstract courtesy of ClinicalTrials.gov, a service of the US National Institute of Health Developed by the National Library of Medicine. ClinicalTrials.gov provides regularly updates information about federally and privately supported clinical research in human volunteers.