Chronic Obstructive Pulmonary DiseasePhase 3NCT00206167
A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
A Phase 3 study testing Budesonide/formoterol pMDI and Formoterol Turbuhaler in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 216 sites in 9 countries.
Trial summary
The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and 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 and Formoterol Turbuhaler
- How many people
- 1,600 participants
- Where
- 216 sitesin 9 countries
- Study dates
- Apr 2005to Sep 2007
- 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
216 sites in 9 countries.
216 sites in 9 countries
United States131 sites
Research Site
Abingdon, Virginia
Research Site
Albany, New York
Research Site
Allentown, Pennsylvania
Research Site
Anderson, South Carolina
Research Site
Atlanta, Georgia
Research Site
Auburn, Maine
Research Site
Avon, Indiana
Research Site
Bangor, Maine
Research Site
Bay Pines, Florida
Research Site
Beaver, Pennsylvania
Research Site
Berlin, New Jersey
Research Site
Birmingham, Alabama
Research Site
Blue Ridge, Georgia
Research Site
Bowling Green, Kentucky
Research Site
Cadillac, Michigan
Research Site
Carmichael, California
Research Site
Chardon, Ohio
Research Site
Charleston, South Carolina
Research Site
Cherry Hill, New Jersey
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
Clearwater, Florida
Research Site
Cleveland, Ohio
Research Site
Colorado Springs, Colorado
Research Site
Conyers, Georgia
Research Site
Corsicana, Texas
Research Site
Cortland, New York
Research Site
Council Bluffs, Iowa
Research Site
Dallas, Texas
Research Site
Decatur, Georgia
Research Site
DeLand, Florida
Research Site
Downingtown, Pennsylvania
Research Site
East Providence, Rhode Island
Research Site
Edina, Minnesota
Research Site
El Paso, Texas
Research Site
Elk Grove Village, Illinois
Research Site
Elmira, New York
Research Site
Elverson, Pennsylvania
Research Site
Evansville, Indiana
Research Site
Fort Smith, Arkansas
Research Site
Fort Worth, Texas
Research Site
Gaffney, South Carolina
Research Site
Greenville, South Carolina
Research Site
Greer, South Carolina
Research Site
Hartford, Connecticut
Research Site
Henderson, Nevada
Research Site
High Point, North Carolina
Research Site
Houston, Texas
Research Site
Huntsville, Alabama
Research Site
Indianapolis, Indiana
Research Site
Iowa City, Iowa
Research Site
Ithaca, New York
Research Site
Jasper, Alabama
Research Site
Kenner, Louisiana
Research Site
Knoxville, Tennessee
Research Site
La Jolla, California
Research Site
Lafayette, Louisiana
Research Site
Lakewood, California
Research Site
Largo, Florida
Research Site
Las Vegas, Nevada
Research Site
Lebanon, Kentucky
Research Site
Longwood, Florida
Research Site
Los Angeles, California
Research Site
Louisville, Kentucky
Research Site
Marietta, Georgia
Research Site
McCook, Nebraska
Research Site
Medford, Oregon
Research Site
Mesa, Arizona
Research Site
Miami, Florida
Research Site
Minneapolis, Minnesota
Research Site
Missoula, Montana
Research Site
Mogadore, Ohio
Research Site
Murrieta, California
Research Site
Muscle Shoals, Alabama
Research Site
New Hyde Park, New York
Research Site
New Port Richey, Florida
Research Site
Normal, Illinois
Research Site
North Chicago, Illinois
Research Site
O'Fallon, Illinois
Research Site
Oklahoma City, Oklahoma
Research Site
Omaha, Nebraska
Research Site
Ormond Beach, Florida
Research Site
Pahrump, Nevada
Research Site
Palo Alto, California
Research Site
Panama City, Florida
Research Site
Peninsula, California
Research Site
Peoria, Illinois
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Pismo Beach, California
Research Site
Pittsburgh, Pennsylvania
Research Site
Portage, Michigan
Research Site
Portland, Oregon
Research Site
Providence, Rhode Island
Research Site
Provo, Utah
Research Site
Rancho Mirage, California
Research Site
Richmond, Virginia
Research Site
Riverside, California
Research Site
Rochester, New York
Research Site
Sacramento, California
Research Site
Saginaw, Michigan
Research Site
Saint Charles, Missouri
Research Site
Salt Lake City, Utah
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Santa Ana, California
Research Site
Scottsbluff, Nebraska
Research Site
Shreveport, Louisiana
Research Site
Slidell, Louisiana
Research Site
South Bend, Indiana
Research Site
Spartanburg, South Carolina
Research Site
Spokane, Washington
Research Site
Springfield, Illinois
Research Site
St Louis, Missouri
Research Site
Stockbridge, Georgia
Research Site
Stockton, California
Research Site
Swarthmore, Pennsylvania
Research Site
Tamarac, Florida
Research Site
Tampa, Florida
Research Site
Taunton, Massachusetts
Research Site
Toledo, Ohio
Research Site
Tonawanda, New York
Research Site
Tucson, Arizona
Research Site
Tulsa, Oklahoma
Research Site
Turnersville, New Jersey
Research Site
Union, South Carolina
Research Site
Upland, Pennsylvania
Research Site
Walnut Creek, California
Research Site
Waterloo, Iowa
Research Site
Winston-Salem, North Carolina
Research Site
Youngstown, Ohio
Hungary28 sites
Research Site
Budapest
Research Site
Cegléd
Research Site
Deszk
Research Site
Érd
Research Site
Füzesabony
Research Site
Godolli
Research Site
Gyöngyös
Research Site
Győr
Research Site
Gyula
Research Site
Jászberény
Research Site
Keszthely
Research Site
Kiskunhalas
Research Site
Mosdós
Research Site
Mosonmagyaróvár
Research Site
Nógrádgárdony
Research Site
Pécs
Research Site
Salgótarján
Research Site
Sárvár
Research Site
Siófok
Research Site
Szarvas
Research Site
Százhalombatta
Research Site
Szeged
Research Site
Szombathely
Research Site
Tatabánya
Research Site
Törökbálint
Research Site
Veszprém
Research Site
Zalaegerszeg
Research Site
Zalaegerszeg-Pozva
Germany26 sites
Research Site
Bad Salzungen
Research Site
Bad Segeberg
Research Site
Berlin
Research Site
Bochum
Research Site
Bonn
Research Site
Cologne
Research Site
Cottbus, Brandenburg
Research Site
Dresden, Saxony
Research Site
Düsseldorf, North Rhine-Westphalia
Research Site
Erfurt
Research Site
Frankfurt
Research Site
Freiburg im Breisgau
Research Site
Geesthacht
Research Site
Gelnhausen
Research Site
Gelsenkirchen
Research Site
Grobhansdorf
Research Site
Hanover
Research Site
Jena-Maua, Thuringia
Research Site
Kassel
Research Site
Leipzig
Research Site
Mainz
Research Site
Marburg
Research Site
München
Research Site
Münster, North Rhine-Westphalia
Research Site
Neuruppin
Research Site
Potsdam
Denmark14 sites
Research Site
Aalborg
Research Site
Christiansfeld
Research Site
Frederikshavn
Research Site
Frederikssund
Research Site
Hellerup
Research Site
Kobenhavn K
Research Site
København N
Research Site
København NV
Research Site
København S
Research Site
Silkeborg
Research Site
Skive
Research Site
Svendborg
Research Site
Værløse
Research Site
Viborg
Bulgaria5 sites
Research Site
Pleven
Research Site
Plovdiv
Research Site
Rousse
Research Site
Sofia
Research Site
Varna
Greece4 sites
Research Site
Athens
Research Site
Hraklion- Crete
Research Site
Larissa
Research Site
Thessaloniki
Romania4 sites
Research Site
Brasov
Research Site
Bucharest
Research Site
Deva
Research Site
Iași
Mexico3 sites
Research Site
Guadalajara, Jalisco
Research Site
Mexico City, D.F.
Research Site
Monterrey, Nuevo León
About this study
Official title: A 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Budesonide/formoterol 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
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 12 months treatment period
Secondary outcomes (4)
Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
Health care utilization
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
all variables assessed over the 12 months treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Study completionSep 2007
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
- 1,600 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Symbicort Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206167
- Sponsor's protocol ID
- D5899C00001
- Other IDs
- EurodraCT No: 2004-001 168-28, SUN
- 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 42551404Bafadhel 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 29331313Make 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 25670896Bleecker 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
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 12-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy and Safety Study of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid Compared to Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
- ClinicalTrials.gov ID
- NCT00206167
- Acronym / sponsor ID
- D5899C00001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Sep 2007 (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.
The purpose of this study is to compare Symbicort in a pressurized metered-dose inhaler (pMDI) with formoterol and placebo in the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
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 | – |
| Formoterol Turbuhaler | Drug | – |
Primary outcome
Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period
4 secondary outcomes
Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
Health care utilization
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
all variables assessed over the 12 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
216 sites in 9 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 and Formoterol Turbuhaler in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 216 sites in 9 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 216 sites in United States, Hungary, Germany, Denmark, Bulgaria and 4 more countries. 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 12 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 NCT00206167, 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.