A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and Symbicort® pMDI 2 x 80/4.5 μg Bid With Formoterol Turbuhaler®, Budesonide pMDI, the Combination of Formoterol Turbuhaler® and Budesonide pMDI, and Placebo in COPD Patients
A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
2 other identifiers
interventional
1,500
5 countries
212
Brief Summary
The purpose of this study is to compare a combination asthma drug (Symbicort) with its two components, budesonide and formoterol, taken individually or in combination, and with placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease
Started Apr 2005
212 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMarch 27, 2009
March 1, 2009
September 13, 2005
March 26, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
Secondary Outcomes (5)
Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
Health care utilization
Pharmacokinetics (subgroup)
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
- all variables assessed over the 6 months treatment period
Interventions
Eligibility Criteria
You may qualify if:
- A clinical diagnosis of COPD with symptoms for more than 2 years
- Smoking history of 10 or more pack years
- A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before first visit.
You may not qualify if:
- A history of asthma
- Patients taking oral steroids.
- Any significant disease or disorder that may jeopardize the safety of the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (212)
Research Site
Birmingham, Alabama, United States
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Jasper, Alabama, United States
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Mobile, Alabama, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Fort Smith, Arkansas, United States
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Little Rock, Arkansas, United States
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Searcy, Arkansas, United States
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Anaheim, California, United States
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Fullerton, California, United States
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Irvine, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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Orange, California, United States
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Rancho Cordova, California, United States
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Riverside, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Sepulveda, California, United States
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Signal Hill, California, United States
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Stockton, California, United States
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Torrance, California, United States
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Walnut Creek, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Wheat Ridge, Colorado, United States
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Bristol, Connecticut, United States
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Waterbury, Connecticut, United States
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Bay Pines, Florida, United States
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Brandon, Florida, United States
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Largo, Florida, United States
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Miami Beach, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Ormond Beach, Florida, United States
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Panama City, Florida, United States
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Pembroke Pines, Florida, United States
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Port Orange, Florida, United States
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Sarasota, Florida, United States
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Blairsville, Georgia, United States
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Blue Ridge, Georgia, United States
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Marietta, Georgia, United States
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Rome, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Bloomington, Illinois, United States
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Chicago, Illinois, United States
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Hines, Illinois, United States
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Normal, Illinois, United States
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North Chicago, Illinois, United States
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O'Fallon, Illinois, United States
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Evansville, Indiana, United States
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South Bend, Indiana, United States
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Iowa City, Iowa, United States
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Waterloo, Iowa, United States
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Mission, Kansas, United States
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Wichita, Kansas, United States
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Lebanon, Kentucky, United States
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Louisville, Kentucky, United States
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Madisonville, Kentucky, United States
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Paducah, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Lafayette, Louisiana, United States
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Marrero, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Sunset, Louisiana, United States
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Auburn, Maine, United States
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Bangor, Maine, United States
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Baltimore, Maryland, United States
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Taunton, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Plymouth, Minnesota, United States
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Saint Paul, Minnesota, United States
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Chesterfield, Missouri, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Papillion, Nebraska, United States
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Scottsbluff, Nebraska, United States
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Las Vegas, Nevada, United States
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Pahrump, Nevada, United States
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Reno, Nevada, United States
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Cherry Hill, New Jersey, United States
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Skillman, New Jersey, United States
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Springfield, New Jersey, United States
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Albuquerque, New Mexico, United States
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Bay Shore, New York, United States
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Buffalo, New York, United States
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Larchmont, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Mogadore, Ohio, United States
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Sylvania, Ohio, United States
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Zanesville, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Easton, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Ridley Park, Pennsylvania, United States
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Swarthmore, Pennsylvania, United States
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West Chester, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Simpsonville, South Carolina, United States
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Spartanburg, South Carolina, United States
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Austin, Texas, United States
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Barker, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Killeen, Texas, United States
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New Braunfels, Texas, United States
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San Antonio, Texas, United States
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Abingdon, Virginia, United States
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Charlottesville, Virginia, United States
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Richmond, Virginia, United States
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Salem, Virginia, United States
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Virginia Beach, Virginia, United States
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Bellingham, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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La Crosse, Wisconsin, United States
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Prague, CZ, Czechia
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Ústí nad Labem, CZ, Czechia
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Beroun, Czechia
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Cvikov, Czechia
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Jarom¿¿, Czechia
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Karlovy Vary, Czechia
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Kladno, Czechia
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Kutná Hora, Czechia
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Liberec, Czechia
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Lovosice, Czechia
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Neratovice, Czechia
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Olomouc, Czechia
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Ostrava, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Rokycany, Czechia
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Strakonice, Czechia
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Ústí nad Labem, Czechia
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Znojmo, Czechia
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Almelo, Netherlands
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Arnhem, Netherlands
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Breda, Netherlands
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Eindhoven, Netherlands
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Groningen, Netherlands
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Harderwijk, Netherlands
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Heerlen, Netherlands
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Nieuwegein, Netherlands
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Terneuzen, Netherlands
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The Hague, Netherlands
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Tilburg, Netherlands
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Utrecht, Netherlands
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Bia¿ystok, Poland
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Bydgoszcz, Poland
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Bystra ¿l¿ska, Poland
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Chrzanów, Poland
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Ch¿ciny, Poland
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Cz¿stochowa, Poland
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Gidle, Poland
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Gorzów Wlkp, Poland
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I¿awa, Poland
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Karpacz, Poland
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Krakow, Poland
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Lublin, Poland
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Ostrów Wielkopolski, Poland
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Otowck, Poland
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Późna, Poland
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Proszowice, Poland
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Radom, Poland
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Siedlce, Poland
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Sopot, Poland
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Szczecin, Poland
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Tarnów, Poland
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Turek, Poland
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Warsaw, Poland
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Wo¿omin, Poland
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Zabrze, Poland
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Zawadzkie, Poland
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¿om¿a, Poland
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¿ód¿, Poland
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Parow, Cape Province, South Africa
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Lenasia, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Witbank, Gauteng, South Africa
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Cape Town, Western Cape, South Africa
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Cape Town, South Africa
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Durban, South Africa
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eMkhomazi, South Africa
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Lyttelton Manor, South Africa
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Port Elizabeth, South Africa
Related Publications (3)
Bafadhel M, Peterson S, De Blas MA, Calverley PM, Rennard SI, Richter K, Fageras M. Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials. Lancet Respir Med. 2018 Feb;6(2):117-126. doi: 10.1016/S2213-2600(18)30006-7. Epub 2018 Jan 10.
PMID: 29331313DERIVEDMake BJ, Eriksson G, Calverley PM, Jenkins CR, Postma DS, Peterson S, Ostlund O, Anzueto A. A score to predict short-term risk of COPD exacerbations (SCOPEX). Int J Chron Obstruct Pulmon Dis. 2015 Jan 27;10:201-9. doi: 10.2147/COPD.S69589. eCollection 2015.
PMID: 25670896DERIVEDBleecker ER, Meyers DA, Bailey WC, Sims AM, Bujac SR, Goldman M, Martin UJ. ADRB2 polymorphisms and budesonide/formoterol responses in COPD. Chest. 2012 Aug;142(2):320-328. doi: 10.1378/chest.11-1655.
PMID: 22383665DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Symbicort Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
April 1, 2005
Study Completion
December 1, 2006
Last Updated
March 27, 2009
Record last verified: 2009-03