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.
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
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.
140 sites in 9 countries
United States92 sites
Research Site
Abingdon, Virginia
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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
South Africa16 sites
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Belvilee, Cape Town
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Bloemfontein
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Boksburg
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Cape Town, South Africa
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Centurion
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Durban, South Africa
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eManzimtoti
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Groenkloof, Pretoria
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Humansdorp
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Korsten, Port Elizabeth
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Port Elizabeth, E Cape
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Pretoria
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Pretoria West
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Roodepoort
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Thaba Tswane, Pretoria
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Tygerberg, Cape Town
Argentina10 sites
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Capital Federal, Buenos Aires
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Córdoba, Córdoba Province
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Corrientes, Corrientes Province
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Mar del Plata, Buenos Aires
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Mendoza, Mendoza Province
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Nueve de Julio, Buenos Aires
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Ramos Mejía, Buenos Aires
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San Juan, San Juan Province
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San Miguel de Tucumán, Tucumán Province
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Vicente López, Buenos Aires
Brazil10 sites
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Curitiba, Paraná
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Florian�polis, Santa Catarina
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Fortaleza, Ceará
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Goiânia, Goiás
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Porta Alegre, Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul
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Recife, Pernambuco
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Rio de Janeiro, Rio de Janeiro
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Santo André, São Paulo
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São Paulo, São Paulo
Peru4 sites
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Jesus Maria, Lima region
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Lima, Lima Province
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San Borja, Lima region
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Surco, Lima region
Chile3 sites
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Rancagua, Región del Libertador General Bernardo O’Higgins
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Santiago, RM
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Valparaíso, Valparaiso
Colombia3 sites
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Barranquilla, Atl�ntico
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Bogota Dc, Cundianmarca
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Medillin, Antioquia
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.
- 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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christer Hultquist, MD, Study director, AstraZeneca
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 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 29331313Jenkins 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 26293575Make 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 25670896Sharafkhaneh 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