Chronic Obstructive Pulmonary DiseasePhase 3NCT00206154

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 Phase 3 study testing Budesonide/formoterol pMDI, Budesonide pMDI and Formoterol Turbuhaler in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 212 sites in 5 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

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) Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Budesonide/formoterol pMDI, Budesonide pMDI and Formoterol Turbuhaler
How many people: 1,500 participants
Where: 212 sitesin 5 countries
Study dates: Apr 2005to Dec 2006
Phase: Phase 3
Are there results?: None posted in the registry

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

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.

Who cannot join

A history of asthma
Patients taking oral steroids.
Any significant disease or disorder that may jeopardize the safety of the patient

Trial locations and contacts

212 sites in 5 countries.

Country

City, postcode or hospital

212 sites in 5 countries

United States143 sites

Research Site
Abingdon, Virginia
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Akron, Ohio
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Albuquerque, New Mexico
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Anaheim, California
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Auburn, Maine
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Austin, Texas
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Baltimore, Maryland
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Bangor, Maine
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Barker, Texas
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Baton Rouge, Louisiana
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Bay Pines, Florida
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Bay Shore, New York
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Bellingham, Washington
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Birmingham, Alabama
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Bismarck, North Dakota
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Blairsville, Georgia
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Bloomington, Illinois
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Blue Ridge, Georgia
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Brandon, Florida
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Bristol, Connecticut
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Buffalo, New York
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Butte, Montana
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Chapel Hill, North Carolina
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Charleston, South Carolina
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Charlottesville, Virginia
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Cherry Hill, New Jersey
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Chesterfield, Missouri
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Chicago, Illinois
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Cincinnati, Ohio
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Clearwater, Florida
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Cleveland, Ohio
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Coeur d'Alene, Idaho
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Colorado Springs, Colorado
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Dallas, Texas
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DeLand, Florida
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Denver, Colorado
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East Providence, Rhode Island
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Easton, Pennsylvania
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El Paso, Texas
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Erie, Pennsylvania
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Eugene, Oregon
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Evansville, Indiana
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Fort Smith, Arkansas
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Fort Worth, Texas
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Fullerton, California
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Glendale, Arizona
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Hershey, Pennsylvania
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Hines, Illinois
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Houston, Texas
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Iowa City, Iowa
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Irvine, California
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Jasper, Alabama
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Killeen, Texas
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La Crosse, Wisconsin
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Lafayette, Louisiana
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Larchmont, New York
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Largo, Florida
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Las Vegas, Nevada
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Lebanon, Kentucky
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Little Rock, Arkansas
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Long Beach, California
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Los Angeles, California
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Louisville, Kentucky
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Madisonville, Kentucky
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Marietta, Georgia
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Marrero, Louisiana
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Medford, Oregon
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Mesa, Arizona
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Miami Beach, Florida
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Mineola, New York
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Minneapolis, Minnesota
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Mission, Kansas
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Mission Viejo, California
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Missoula, Montana
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Mobile, Alabama
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Mogadore, Ohio
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Naples, Florida
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New Braunfels, Texas
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New Orleans, Louisiana
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New York, New York
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Normal, Illinois
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North Chicago, Illinois
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O'Fallon, Illinois
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Ocala, Florida
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Oklahoma City, Oklahoma
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Omaha, Nebraska
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Orange, California
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Ormond Beach, Florida
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Paducah, Kentucky
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Pahrump, Nevada
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Panama City, Florida
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Papillion, Nebraska
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Pembroke Pines, Florida
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pittsburgh, Pennsylvania
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Plymouth, Minnesota
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Port Orange, Florida
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Portland, Oregon
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Raleigh, North Carolina
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Rancho Cordova, California
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Reno, Nevada
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Richmond, Virginia
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Ridley Park, Pennsylvania
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Riverside, California
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Rochester, New York
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Rome, Georgia
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Saint Charles, Missouri
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Saint Paul, Minnesota
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Salem, Virginia
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San Antonio, Texas
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San Diego, California
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San Jose, California
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Sarasota, Florida
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Scottsbluff, Nebraska
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Searcy, Arkansas
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Seattle, Washington
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Sepulveda, California
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Shreveport, Louisiana
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Signal Hill, California
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Simpsonville, South Carolina
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Skillman, New Jersey
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South Bend, Indiana
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Spartanburg, South Carolina
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Spokane, Washington
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Springfield, New Jersey
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St Louis, Missouri
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Stockton, California
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Sunset, Louisiana
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Swarthmore, Pennsylvania
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Sylvania, Ohio
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Tacoma, Washington
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Taunton, Massachusetts
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Torrance, California
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Virginia Beach, Virginia
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Walnut Creek, California
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Waterbury, Connecticut
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Waterloo, Iowa
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West Chester, Pennsylvania
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Wheat Ridge, Colorado
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Wichita, Kansas
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Winston-Salem, North Carolina
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Zanesville, Ohio

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Poland28 sites

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¿ód¿
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¿om¿a
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Bia¿ystok
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Bydgoszcz
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Bystra ¿l¿ska
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Ch¿ciny
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Chrzanów
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Cz¿stochowa
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Gidle
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Gorzów Wlkp
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I¿awa
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Karpacz
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Krakow
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Lublin
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Ostrów Wielkopolski
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Otowck
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Późna
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Proszowice
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Radom
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Siedlce
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Sopot
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Szczecin
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Tarnów
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Turek
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Warsaw
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Wo¿omin
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Zabrze
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Czechia19 sites

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Beroun
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Cvikov
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Jarom¿¿
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Karlovy Vary
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Kladno
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Kutná Hora
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Liberec
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Lovosice
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Neratovice
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Olomouc
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Ostrava
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Pilsen
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Prague, CZ
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Prague
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Rokycany
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Strakonice
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Ústí nad Labem, CZ
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Ústí nad Labem
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Znojmo

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Netherlands12 sites

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Almelo
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Arnhem
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Breda
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Eindhoven
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Groningen
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Harderwijk
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Heerlen
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Nieuwegein
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Terneuzen
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The Hague
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Tilburg
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Utrecht

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South Africa10 sites

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Cape Town, Western Cape
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Cape Town
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Durban
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eMkhomazi
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Lenasia, Gauteng
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Lyttelton Manor
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Parow, Cape Province
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Port Elizabeth
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Pretoria, Gauteng
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Witbank, Gauteng

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About this study

Official title: 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

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Budesonide/formoterol pMDI, Budesonide pMDI, Formoterol Turbuhaler
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

Budesonide/formoterol pMDIDrug
Budesonide pMDIDrug
Formoterol TurbuhalerDrug

What is being measured

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

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

Timeline

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

Apr 2005Dec 2006

First posted21 Sep 2005 (estimated)
Study startApr 2005
Study completionDec 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00206154
Sponsor's protocol ID: D5899C00002
Other IDs: EurodraCT No: 2004-001183-41
Status last verified: Mar 2009
First submitted: 13 Sep 2005
Last updated: 27 Mar 2009
Results posted: No

Publications

Spata E, Jauhiainen A, Da Silva CA. Impact of season and geography on COPDCompEx: a composite endpoint for COPD trials. Respir Med Res. 2026 Jul 12;90:101305. doi: 10.1016/j.resmer.2026.101305. Online ahead of print.
PubMed 42551404
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.
PubMed 29331313
Make 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.
PubMed 25670896
Bleecker 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.
PubMed 22383665

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00206154
Acronym / sponsor ID: D5899C00002
Conditions: Chronic Obstructive Pulmonary Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,500 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2005
Study completion: Dec 2006 (actual)
First posted: 21 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

A history of asthma
Patients taking oral steroids.
Any significant disease or disorder that may jeopardize the safety of the patient

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Budesonide/formoterol pMDI	Drug	–
Budesonide pMDI	Drug	–
Formoterol Turbuhaler	Drug	–

Primary outcome

Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period

5 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2009.
Derived from this study: PubMed 42551404Spata E, Jauhiainen A, Da Silva CA. Impact of season and geography on COPDCompEx: a composite endpoint for COPD trials. Respir Med Res. 2026 Jul 12;90:101305. doi: 10.1016/j.resmer.2026.101305. Online ahead of print.
Derived from this study: PubMed 29331313Bafadhel 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.
Derived from this study: PubMed 25670896Make 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.
Derived from this study: PubMed 22383665Bleecker 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.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca Symbicort Medical Science Director, MD study director

AstraZeneca

212 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide/formoterol pMDI, Budesonide pMDI and Formoterol Turbuhaler in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 212 sites in 5 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 3 inclusion and 3 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 27 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 212 sites in United States, Poland, Czechia, Netherlands, South Africa. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period. 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 NCT00206154, which also lists 4 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 27 Mar 2009.