A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
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
1 other identifier
interventional
1,200
9 countries
140
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease
Started Jan 2007
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 5, 2007
CompletedFirst Posted
Study publicly available on registry
January 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
September 16, 2010
CompletedSeptember 16, 2010
August 1, 2010
2.6 years
January 5, 2007
August 18, 2010
August 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
12 months
Rate of Exacerbations Per Subject-year
Rate of exacerbations per subject-year
12 months
Secondary Outcomes (6)
Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
12 months
Morning Peak Expiratory Flow (PEF)
12 months
Evening PEF
12 months
Dyspnea Symptom Scores
12 months
Use of Rescue Medication
12 months
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (140)
Research Site
Jasper, Alabama, United States
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Mobile, Alabama, United States
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Tucson, Arizona, United States
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Fort Smith, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Foothill Ranch, California, United States
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Fullerton, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Banos, California, United States
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Mission Viejo, California, United States
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Pismo Beach, California, United States
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Rancho Cordova, California, United States
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Rancho Mirage, California, United States
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Riverside, California, United States
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Rolling Hills Estates, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Sepulveda, California, United States
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Torrance, California, United States
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Englewood, Colorado, United States
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Wheat Ridge, Colorado, United States
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Stanford, Connecticut, United States
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DeLand, Florida, United States
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Opa-locka, Florida, United States
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Orange City, Florida, United States
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Orlando, Florida, United States
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Panama City, Florida, United States
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Pensacola, Florida, United States
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Saint Cloud, Florida, United States
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Sarasota, Florida, United States
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Augusta, Georgia, United States
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Blue Ridge, Georgia, United States
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Marietta, Georgia, United States
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Boise, Idaho, United States
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Coeur d'Alene, Idaho, United States
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Chicago, Illinois, United States
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Council Bluffs, Iowa, United States
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Witchita, Kansas, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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Sunset, Louisiana, United States
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Bangor, Maine, United States
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Pittsfield, Massachusetts, United States
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Waltham, Massachusetts, United States
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Chesterfield, Missouri, United States
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Florissant, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Papillion, Nebraska, United States
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Las Vegas, Nevada, United States
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Springfield, New Jersey, United States
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Bronxville, New York, United States
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Elmira, New York, United States
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Larchmont, New York, United States
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Charlotte, North Carolina, United States
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Elizabeth City, North Carolina, United States
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Hickory, North Carolina, United States
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Chardon, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Sylvania, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Beaver, Pennsylvania, United States
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Bensalem, Pennsylvania, United States
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Downingtown, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Landsdale, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Warminster, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Gaffney, South Carolina, United States
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Greenville, South Carolina, United States
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Prosperity, South Carolina, United States
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Spartanburg, South Carolina, United States
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Union, South Carolina, United States
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Fayetteville, Tennessee, United States
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Boerne, Texas, United States
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Houston, Texas, United States
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McKinney, Texas, United States
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San Antonio, Texas, United States
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Abingdon, Virginia, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Capital Federal, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Nueve de Julio, Buenos Aires, Argentina
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Ramos Mejía, Buenos Aires, Argentina
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Vicente López, Buenos Aires, Argentina
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Corrientes, Corrientes Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Mendoza, Mendoza Province, Argentina
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San Juan, San Juan Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Fortaleza, Ceará, Brazil
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Recife, Pernambuco, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porta Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Florian�polis, Santa Catarina, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Valparaíso, Región de Valparaíso, Chile
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Rancagua, Región del Libertador General Bernardo O’Higgins, Chile
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Santiago, RM, Chile
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Medillin, Antioquia, Colombia
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Barranquilla, Atl�ntico, Colombia
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Bogota Dc, Cundianmarca, Colombia
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Guadalajara, Jalisco, Mexico
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Lima, Lima Province, Peru
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Jesus Maria, Lima region, Peru
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San Borja, Lima region, Peru
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Surco, Lima region, Peru
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Belvilee, Cape Town, South Africa
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Tygerberg, Cape Town, South Africa
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Port Elizabeth, E Cape, South Africa
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Korsten, Port Elizabeth, South Africa
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Groenkloof, Pretoria, South Africa
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Thaba Tswane, Pretoria, South Africa
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Cape Town, South Africa, South Africa
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Durban, South Africa, South Africa
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Bloemfontein, South Africa
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Boksburg, South Africa
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Centurion, South Africa
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eManzimtoti, South Africa
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Humansdorp, South Africa
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Pretoria, South Africa
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Pretoria West, South Africa
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Roodepoort, South Africa
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Distrito Capital, Miranda, Venezuela
Related Publications (4)
Bafadhel M, Peterson S, De Blas MA, Calverley PM, Rennard SI, Richter K, Fageras M. Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials. Lancet Respir Med. 2018 Feb;6(2):117-126. doi: 10.1016/S2213-2600(18)30006-7. Epub 2018 Jan 10.
PMID: 29331313DERIVEDJenkins 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.
PMID: 26293575DERIVEDMake BJ, Eriksson G, Calverley PM, Jenkins CR, Postma DS, Peterson S, Ostlund O, Anzueto A. A score to predict short-term risk of COPD exacerbations (SCOPEX). Int J Chron Obstruct Pulmon Dis. 2015 Jan 27;10:201-9. doi: 10.2147/COPD.S69589. eCollection 2015.
PMID: 25670896DERIVEDSharafkhaneh 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.
PMID: 22033040DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Christer Hultquist, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 5, 2007
First Posted
January 9, 2007
Study Start
January 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
September 16, 2010
Results First Posted
September 16, 2010
Record last verified: 2010-08