Chronic Obstructive Pulmonary DiseasePhase 3NCT00419744

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

A Phase 3 study testing Budesonide/formoterol (SYMBICORT) pMDI and Formoterol Turbuhaler in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 140 sites in 9 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 determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations. 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 (SYMBICORT) pMDI and Formoterol Turbuhaler
How many people: 1,200 participants
Where: 140 sitesin 9 countries
Study dates: Jan 2007to Aug 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 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

Who cannot join

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

Trial locations and contacts

140 sites in 9 countries.

Country

City, postcode or hospital

140 sites in 9 countries

United States92 sites

Research Site
Abingdon, Virginia
Research Site
Anaheim, California
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Augusta, Georgia
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Bangor, Maine
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Beaver, Pennsylvania
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Bensalem, Pennsylvania
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Blue Ridge, Georgia
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Boerne, Texas
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Boise, Idaho
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Bronxville, New York
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Chardon, Ohio
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Charleston, South Carolina
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Charlotte, North Carolina
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Chesterfield, Missouri
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Chicago, Illinois
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Cincinnati, Ohio
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Coeur d'Alene, Idaho
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Columbus, Ohio
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Council Bluffs, Iowa
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DeLand, Florida
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Downingtown, Pennsylvania
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East Providence, Rhode Island
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Elizabeth City, North Carolina
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Elmira, New York
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Englewood, Colorado
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Fayetteville, Tennessee
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Florissant, Missouri
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Foothill Ranch, California
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Fort Smith, Arkansas
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Fullerton, California
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Gaffney, South Carolina
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Greenville, South Carolina
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Harrisburg, Pennsylvania
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Hickory, North Carolina
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Houston, Texas
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Jasper, Alabama
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Kansas City, Missouri
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Landsdale, Pennsylvania
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Larchmont, New York
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Las Vegas, Nevada
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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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Los Banos, California
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Marietta, Georgia
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Marrero, Louisiana
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McKinney, Texas
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Medford, Oregon
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Metairie, Louisiana
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Mission Viejo, California
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Missoula, Montana
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Mobile, Alabama
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Oklahoma City, Oklahoma
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Omaha, Nebraska
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Opa-locka, Florida
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Orange City, Florida
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Orlando, Florida
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Panama City, Florida
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Papillion, Nebraska
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Pensacola, Florida
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Philadelphia, Pennsylvania
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Pismo Beach, California
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Pittsburgh, Pennsylvania
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Pittsfield, Massachusetts
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Portland, Oregon
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Prosperity, South Carolina
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Rancho Cordova, California
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Rancho Mirage, California
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Riverside, California
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Rolling Hills Estates, California
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Sacramento, California
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Saint Cloud, Florida
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San Antonio, Texas
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San Diego, California
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Sarasota, Florida
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Sepulveda, California
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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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Stanford, Connecticut
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Sunset, Louisiana
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Sylvania, Ohio
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Tacoma, Washington
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Torrance, California
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Tucson, Arizona
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Union, South Carolina
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Waltham, Massachusetts
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Warminster, Pennsylvania
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Wheat Ridge, Colorado
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Witchita, Kansas
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Yardley, Pennsylvania

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About this study

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

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.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Budesonide/formoterol (SYMBICORT) pMDI, Formoterol Turbuhaler
Keywords: COPD
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 (SYMBICORT) pMDIDrug
Formoterol TurbuhalerDrug

What is being measured

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

Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.
Measured: 12 months
Rate of Exacerbations Per Subject-year
Rate of exacerbations per subject-year
Measured: 12 months

Secondary outcomes (6)

Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Change in pre-dose FEV1 from baseline to the average of the randomized treatment period, as calculated by averaging treatment period FEV1 values and subtracting the pre-dose value.
Measured: 12 months
Morning Peak Expiratory Flow (PEF)
Change in morning PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline morning PEF value.
Measured: 12 months
Evening PEF
Change in evening PEF from baseline to the average of the randomized treatment period, as calculated by averaging treatment period PEF values and subtracting the baseline evening PEF value.
Measured: 12 months
Dyspnea Symptom Scores
Change from baseline of Dyspnea symptoms evaluated using the breathlessness diary, a 5-point Likert-type scale, ranging from 0 to 4 with higher scores indicating a more severe manifestation of the Dyspnea symptom. Change from baseline was calculated by averaging treatment period Dyspnea scores and subtracting the baseline Dyspnea scores.
Measured: 12 months
Use of Rescue Medication
Change from baseline in the use of beta-2 agonists, as calculated by averaging treatment period inhalations per day and subtracting the baseline number of inhalations per day.
Measured: 12 months
St. George's Respiratory Questionnaire (SGRQ) Score
Change from baseline in the SGRQ overall score, as calculated by averaging treatment period SGRQ scores and subtracting the baseline SGRQ scores. The SGRQ contains 3 domains: Symptoms (distress due to respiratory symptoms, 8 questions), Activity (disturbance of physical activity, 16 questions), and Impacts (overall impact on daily life and well-being, 26 questions). Lower scores are associated with less severe symptoms.
Measured: 12 months

Timeline

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

Jan 2007Aug 2009

First posted9 Jan 2007 (estimated)
Study startJan 2007
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)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: 1,200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00419744
Sponsor's protocol ID: D589CC00003
Status last verified: Aug 2010
First submitted: 5 Jan 2007
Last updated: 16 Sep 2010
Results posted: Yes, on ClinicalTrials.gov

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
Jenkins CR, Postma DS, Anzueto AR, Make BJ, Peterson S, Eriksson G, Calverley PM. Reliever salbutamol use as a measure of exacerbation risk in chronic obstructive pulmonary disease. BMC Pulm Med. 2015 Aug 21;15:97. doi: 10.1186/s12890-015-0077-0.
PubMed 26293575
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
Sharafkhaneh A, Southard JG, Goldman M, Uryniak T, Martin UJ. Effect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized study. Respir Med. 2012 Feb;106(2):257-68. doi: 10.1016/j.rmed.2011.07.020. Epub 2011 Oct 26.
PubMed 22033040

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

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Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00419744
Acronym / sponsor ID: D589CC00003
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,200 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 9 Jan 2007 (estimated)
Results: Posted 16 Sep 2010

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

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 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

Key exclusion criteria (4 listed)

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

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 (SYMBICORT) pMDI	Drug	–
Formoterol Turbuhaler	Drug	–

Primary outcome

Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year
Time frame: 12 months
Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.
Rate of Exacerbations Per Subject-year
Time frame: 12 months
Rate of exacerbations per subject-year

6 secondary outcomes

Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 12 months
Morning Peak Expiratory Flow (PEF)
Time frame: 12 months
Evening PEF
Time frame: 12 months
Dyspnea Symptom Scores
Time frame: 12 months
Use of Rescue Medication
Time frame: 12 months
St. George's Respiratory Questionnaire (SGRQ) Score
Time frame: 12 months

Results and safety

Results posted to the registry on 16 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SYM 160/4.5 X 2 BID	407	290
SYM 80/4.5 X 2 BID	408	290
FOR 4.5 X 2 BID	404	271

Primary outcome: Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year

Time frame: 12 months. Number. Unit: Exacerbations

Measure	SYM 160/4.5 X 2 BID n = 404	SYM 80/4.5 X 2 BID n = 403	FOR 4.5 X 2 BID n = 403
Value	0.75	0.84	1.14

Primary outcome: Rate of Exacerbations Per Subject-year

Time frame: 12 months. Number. Unit: Rate

Measure	SYM 160/4.5 X 2 BID n = 404	SYM 80/4.5 X 2 BID n = 403	FOR 4.5 X 2 BID n = 403
Value	0.639	0.745	1.029

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SYM 160/4.5 X 2 BID	79 of 407 (19.4%)	193 of 407 (47.4%)	Not reported
SYM 80/4.5 X 2 BID	61 of 408 (15%)	177 of 408 (43.4%)	Not reported
FOR 4.5 X 2 BID	73 of 403 (18.1%)	176 of 403 (43.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 26293575Jenkins CR, Postma DS, Anzueto AR, Make BJ, Peterson S, Eriksson G, Calverley PM. Reliever salbutamol use as a measure of exacerbation risk in chronic obstructive pulmonary disease. BMC Pulm Med. 2015 Aug 21;15:97. doi: 10.1186/s12890-015-0077-0.
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 22033040Sharafkhaneh A, Southard JG, Goldman M, Uryniak T, Martin UJ. Effect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized study. Respir Med. 2012 Feb;106(2):257-68. doi: 10.1016/j.rmed.2011.07.020. Epub 2011 Oct 26.

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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.

Christer Hultquist, MD study director

AstraZeneca

140 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 (SYMBICORT) pMDI and Formoterol Turbuhaler in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 140 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 4 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 16 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, South Africa, Argentina, Brazil, Peru 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?

Yes. Results are posted in the registry (first posted 16 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Total Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient-treatment Year (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT00419744, which also lists 5 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 16 Sep 2010.