A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Budesonide/formoterol (SYMBICORT) pMDI (Drug); Formoterol Turbuhaler (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Christer Hultquist, MD, Study Director, Affiliation: AstraZeneca

Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-280-7155, Email: information.center@astrazeneca.com

The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.

Official title: A Phase IIIB, 12-Month, Double-Blind, Double-Dummy,Randomised, Parallel-Group, Multicentre Exacerbation Study of SYMBICORT® pMDI 160/4.5 μg x 2 Actuations Twice-Daily and 80/4.5 μg x 2 Actuations Twice-Daily Compared to Formoterol Turbuhaler® 4.5 μg x 2 Inhalations Twice-Daily in COPD Subjects

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary objective of this study is to compare efficacy for preventing exacerbations of SYMBICORT pMDI 160/4.5 μg x 2 actuations bid and 80/4.5 μg x 2 actuations bid compared to formoterol Turbuhaler® 4.5 μg x 2 inhalations bid in COPD subjects.

Secondary outcome: The secondary objective of this study is to demonstrate the safety of both SYMBICORT® pMDI doses compared to that of formoterol Turbuhaler® in subjects with COPD.

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- A current clinical diagnosis of COPD with COPD symptoms for more than 2 years

- Current smoker or smoking history of 10 or more pack years (1 pack year = 20

cigarettes smoked per day for one year)

- A history of at least 1 COPD exacerbations requiring a course of steroids and/or

antibiotics within 1-12 months before the first visit

Exclusion Criteria:

- A history of asthma at or after 18 years of age

- A history of allergic rhinitis at or after 18 years of age

- Subjects taking oral steroids

- Any significant disease or disorder that may jeopardize a subject's safety

AstraZeneca Clinical Study Information, Phone: 800-280-7155, Email: information.center@astrazeneca.com

Research Site, Tucuman, Argentina; Recruiting

Research Site, Buenos Aires, Argentina; Recruiting

Research Site, Chaco, Argentina; Recruiting

Research Site, Cordoba, Argentina; Recruiting

Research Site, Mendoza, Argentina; Recruiting

Research Site, Corrientes, Argentina; Recruiting

Research Site, San Juan, Argentina; Recruiting

Research Site, Rancagua, Chile; Recruiting

Research Site, Santiago, Chile; Recruiting

Research Site, Distrito Federal, Mexico; Not yet recruiting

Research Site, Tygerberg, Cape Town, South Africa; Recruiting

Research Site, Bryanston, Johannesburg, South Africa; Recruiting

Research Site, Berea, Durban, South Africa; Recruiting

Research Site, Kraaifontein, South Africa; Recruiting

Research Site, Bellville, Cape Town, South Africa; Recruiting

Research Site, Worcester, South Africa; Recruiting

Research Site, Pretoria West, South Africa; Recruiting

Research Site, Korsten, Port Elizabeth, South Africa; Recruiting

Research Site, Mowbray, Cape Town, South Africa; Recruiting

Research Site, Gatesville, South Africa; Recruiting

Research Site, Bloemfontein, South Africa; Recruiting

Research Site, Amanzimtoti, South Africa; Recruiting

Research Site, Pretoria, South Africa; Recruiting

Research Site, Groenkloof, Pretoria, South Africa; Recruiting

Research Site, Centurion, South Africa; Recruiting

Research Site, Boksburg, South Africa; Recruiting

Research Site, Thaba Tswane, South Africa; Recruiting

Research Site, Les Marais, Pretoria, South Africa; Recruiting

Research Site, Roodepoort, South Africa; Recruiting

Research Site, Humansdorp, South Africa; Recruiting

Research Site, Chaguarmos, Venezuela; Recruiting

Research Site, Barquisimento, Venezuela; Not yet recruiting

Research Site, Mobile, Alabama, United States; Recruiting

Research Site, Jasper, Alabama, United States; Recruiting

Research Site, Medellin, Antioquia, Colombia; Recruiting

Research Site, Glendale, Arizona, United States; Recruiting

Research Site, Phoenix, Arizona, United States; Not yet recruiting

Research Site, Fort Smith, Arkansas, United States; Recruiting

Research Site, Little Rock, Arkansas, United States; Recruiting

Research Site, Barranquilla, Atlantico, Colombia; Not yet recruiting

Research Site, Capitol Federal, Buenos Aires, Argentina; Recruiting

Research Site, Fortaleza, CE, Brazil; Recruiting

Research Site, Foothill Ranch, California, United States; Recruiting

Research Site, Fresno, California, United States; Not yet recruiting

Research Site, Fullerton, California, United States; Recruiting

Research Site, Long Beach, California, United States; Recruiting

Research Site, Los Angeles, California, United States; Recruiting

Research Site, Rancho Mirage, California, United States; Recruiting

Research Site, Riverside, California, United States; Recruiting

Research Site, Rolling Hills Estates, California, United States; Recruiting

Research Site, San Diego, California, United States; Recruiting

Research Site, Solana Beach, California, United States; Not yet recruiting

Research Site, Torrance, California, United States; Recruiting

Research Site, Sacramento, California, United States; Recruiting

Research Site, Fullerton, California, United States; Not yet recruiting

Research Site, Sepulveda, California, United States; Not yet recruiting

Research Site, Pismo Beach, California, United States; Recruiting

Research Site, Caracas Dtto, Capital, Venezuela; Not yet recruiting

Research Site, Centennial, Colorado, United States; Recruiting

Research Site, Stanford, Connecticut, United States; Recruiting

Research Site, Bogota, Cundinamarca, Colombia; Recruiting

Research Site, Bogota DC, Cundinamarca, Colombia; Recruiting

Research Site, Brasillia, DF, Brazil; Not yet recruiting

Research Site, Deland, Florida, United States; Recruiting

Research Site, Opalocka, Florida, United States; Recruiting

Research Site, Orlando, Florida, United States; Recruiting

Research Site, Panama City, Florida, United States; Recruiting

Research Site, Pensacola, Florida, United States; Recruiting

Research Site, Port Orange, Florida, United States; Recruiting

Research Site, Sarasota, Florida, United States; Recruiting

Research Site, St. Cloud, Florida, United States; Recruiting

Research Site, Andar, Goiania, GO, Brazil; Recruiting

Research Site, Augusta, Georgia, United States; Recruiting

Research Site, Marietta, Georgia, United States; Not yet recruiting

Research Site, Coeur d'Alene, Idaho, United States; Recruiting

Research Site, Valparaiso, Indiana, United States; Recruiting

Research Site, Council Bluffs, Iowa, United States; Recruiting

Research Site, Guadalajara, Jalisco, Mexico; Recruiting

Research Site, Zapopan, Jalisco, Mexico; Recruiting

Research Site, Lima, Lima 01, Peru; Recruiting

Research Site, Jesus Maria, Lima 11, Peru; Recruiting

Research Site, Lima, Lima 27, Peru; Recruiting

Research Site, San Martin de Porres, Lima 31, Peru; Not yet recruiting

Research Site, Surco Lima, Lima 33, Peru; Recruiting

Research Site, San Borja, Lima 41, Peru; Recruiting

Research Site, Marrero, Louisiana, United States; Recruiting

Research Site, Sunset, Louisiana, United States; Recruiting

Research Site, Bangor, Maine, United States; Recruiting

Research Site, Pittsfield, Massachusetts, United States; Recruiting

Research Site, Merida, Merica, Venezuela; Recruiting

Research Site, Chesterfield, Missouri, United States; Not yet recruiting

Research Site, Florissant, Missouri, United States; Recruiting

Research Site, Kansas City, Missouri, United States; Not yet recruiting

Research Site, St. Louis, Missouri, United States; Recruiting

Research Site, Missoula, Montana, United States; Recruiting

Research Site, Omaha, Nebraska, United States; Recruiting

Research Site, Papillion, Nebraska, United States; Recruiting

Research Site, Las Vegas, Nevada, United States; Recruiting

Research Site, Summit, New Jersey, United States; Recruiting

Research Site, Ithaca, New York, United States; Not yet recruiting

Research Site, Larchmont, New York, United States; Recruiting

Research Site, Elmira, New York, United States; Recruiting

Research Site, Charlotte, North Carolina, United States; Recruiting

Research Site, Elizabeth City, North Carolina, United States; Recruiting

Research Site, Hickory, North Carolina, United States; Not yet recruiting

Research Site, Monterey, Nuevo Leon, Mexico; Not yet recruiting

Research Site, Chardon, Ohio, United States; Recruiting

Research Site, Columbus, Ohio, United States; Recruiting

Research Site, Sylvania, Ohio, United States; Recruiting

Research Site, Eugene, Oregon, United States; Not yet recruiting

Research Site, Medford, Oregon, United States; Recruiting

Research Site, Portland, Oregon, United States; Recruiting

Research Site, Tejipio Recife, PE, Brazil; Not yet recruiting

Research Site, Andar, Recife, PE, Brazil; Recruiting

Research Site, Curitiba, PR, Brazil; Recruiting

Research Site, Beaver, Pennsylvania, United States; Recruiting

Research Site, Bensalem, Pennsylvania, United States; Recruiting

Research Site, Downingtown, Pennsylvania, United States; Recruiting

Research Site, Harrisburg, Pennsylvania, United States; Recruiting

Research Site, Lansdale, Pennsylvania, United States; Recruiting

Research Site, Philadelphia, Pennsylvania, United States; Recruiting

Research Site, Pittsburgh, Pennsylvania, United States; Recruiting

Research Site, Warminster, Pennsylvania, United States; Recruiting

Research Site, Yardley, Pennsylvania, United States; Recruiting

Research Site, Rio de Janeiro, RJ, Brazil; Recruiting

Research Site, Porte Alegre, RS, Brazil; Recruiting

Research Site, Pelotas, RS, Brazil; Recruiting

Research Site, Torre Beta, Porto Alegre, RS, Brazil; Recruiting

Research Site, East Providence, Rhode Island, United States; Recruiting

Research Site, Florianopolis, SC, Brazil; Recruiting

Research Site, Santos, SP, Brazil; Not yet recruiting

Research Site, Sao Paulo, SP, Brazil; Recruiting

Research Site, Santo Andre, SP, Brazil; Recruiting

Research Site, Bucaramanga, Santander, Colombia; Not yet recruiting

Research Site, Providencia, Santiago, Chile; Recruiting

Research Site, Charleston, South Carolina, United States; Recruiting

Research Site, Gaffney, South Carolina, United States; Recruiting

Research Site, Greenville, South Carolina, United States; Recruiting

Research Site, Prosperity, South Carolina, United States; Recruiting

Research Site, Spartanburg, South Carolina, United States; Recruiting

Research Site, Union, South Carolina, United States; Recruiting

Research Site, Simpsonville, South Carolina, United States; Recruiting

Research Site, Villahermosa, Tabasco, Mexico; Not yet recruiting

Research Site, Fayetteville, Tennessee, United States; Recruiting

Research Site, Boerne, Texas, United States; Recruiting

Research Site, McKinney, Texas, United States; Recruiting

Research Site, Abingdon, Virginia, United States; Recruiting

Research Site, Tacoma, Washington, United States; Recruiting

Research Site, Merida, Yucatan, Mexico; Not yet recruiting

Research Site, Maracaibo, Zulia, Venezuela; Not yet recruiting

Starting date: January 2007
Last updated: May 5, 2008