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 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

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)

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Budesonide/formoterol pMDI; Drug: Budesonide pMDI; Drug: Formoterol Turbuhaler

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czech Republic
  • Beroun, Czech Republic
    • Research Site
  • Cvikov, Czech Republic
    • Research Site
  • Jarom¿¿, Czech Republic
    • Research Site
  • Karlovy Vary, Czech Republic
    • Research Site
  • Kladno, Czech Republic
    • Research Site
  • Kutná Hora, Czech Republic
    • Research Site
  • Liberec, Czech Republic
    • Research Site
  • Lovosice, Czech Republic
    • Research Site
  • Neratovice, Czech Republic
    • Research Site
  • Olomouc, Czech Republic
    • Research Site
  • Ostrava 1, Czech Republic
    • Research Site
  • Plzen, Czech Republic
    • Research Site
  • Praha 1, Czech Republic
    • Research Site
  • Praha 2, Czech Republic
    • Research Site
  • Praha 5, Czech Republic
    • Research Site
  • Praha 8, Czech Republic
    • Research Site
  • Rokycany, Czech Republic
    • Research Site
  • Strakonice, Czech Republic
    • Research Site
  • Znojmo, Czech Republic
    • Research Site
  • Ústí nad Labem, Czech Republic
    • Research Site
  • CZ
    • Praha 8, CZ, Czech Republic
      • Research Site
    • Ústí nad Labem, CZ, Czech Republic
      • Research Site
• Netherlands
  • Almelo, Netherlands
    • Research Site
  • Arnhem, Netherlands
    • Research Site
  • Breda, Netherlands
    • Research Site
  • Den Haag, Netherlands
    • Research Site
  • Eindhoven, Netherlands
    • Research Site
  • Groningen, Netherlands
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  • Harderwijk, Netherlands
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  • Heerlen, Netherlands
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  • Nieuwegein, Netherlands
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  • Terneuzen, Netherlands
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  • Tilburg, Netherlands
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  • Utrecht, Netherlands
    • Research Site
• Poland
  • Bia¿ystok, Poland
    • Research Site
  • Bydgoszcz, Poland
    • Research Site
  • Bystra ¿l¿ska, Poland
    • Research Site
  • Chrzanów, Poland
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  • Ch¿ciny, Poland
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  • Cz¿stochowa, Poland
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  • Gidle, Poland
    • Research Site
  • Gorzów Wlkp, Poland
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  • I¿awa, Poland
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  • Karpacz, Poland
    • Research Site
  • Kraków, Poland
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  • Lublin, Poland
    • Research Site
  • Ostrów Wielkopolski, Poland
    • Research Site
  • Otowck, Poland
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  • Pozna¿, Poland
    • Research Site
  • Proszowice, Poland
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  • Radom, Poland
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  • Siedlce, Poland
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  • Sopot, Poland
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  • Szczecin, Poland
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  • Tarnów, Poland
    • Research Site
  • Turek, Poland
    • Research Site
  • Warszawa, Poland
    • Research Site
  • Wo¿omin, Poland
    • Research Site
  • Zabrze, Poland
    • Research Site
  • Zawadzkie, Poland
    • Research Site
  • ¿om¿a, Poland
    • Research Site
  • ¿ód¿, Poland
    • Research Site
• South Africa
  • Cape Town, South Africa
    • Research Site
  • Durban, South Africa
    • Research Site
  • Lyttelton Manor, South Africa
    • Research Site
  • Port Elizabeth, South Africa
    • Research Site
  • Umkomaas, South Africa
    • Research Site
  • Cape Province
    • Parow, Cape Province, South Africa
      • Research Site
  • Gauteng
    • Lenasia, Gauteng, South Africa
      • Research Site
    • Pretoria, Gauteng, South Africa
      • Research Site
    • Witbank, Gauteng, South Africa
      • Research Site
  • Western Cape
    • Cape Town, Western Cape, South Africa
      • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Research Site
    • Jasper, Alabama, United States
      • Research Site
    • Mobile, Alabama, United States
      • Research Site
  • Arizona
    • Glendale, Arizona, United States
      • Research Site
    • Mesa, Arizona, United States
      • Research Site
    • Phoenix, Arizona, United States
      • Research Site
  • Arkansas
    • Fort Smith, Arkansas, United States
      • Research Site
    • Little Rock, Arkansas, United States
      • Research Site
    • Searcy, Arkansas, United States
      • Research Site
  • California
    • Anaheim, California, United States
      • Research Site
    • Fullerton, California, United States
      • Research Site
    • Irvine, California, United States
      • Research Site
    • Long Beach, California, United States
      • Research Site
    • Los Angeles, California, United States
      • Research Site
    • Mission Viejo, California, United States
      • Research Site
    • Orange, California, United States
      • Research Site
    • Rancho Cordova, California, United States
      • Research Site
    • Riverside, California, United States
      • Research Site
    • San Diego, California, United States
      • Research Site
    • San Jose, California, United States
      • Research Site
    • Sepulveda, California, United States
      • Research Site
    • Signal Hill, California, United States
      • Research Site
    • Stockton, California, United States
      • Research Site
    • Torrance, California, United States
      • Research Site
    • Walnut Creek, California, United States
      • Research Site
  • Colorado
    • Colorado Springs, Colorado, United States
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    • Denver, Colorado, United States
      • Research Site
    • Wheat Ridge, Colorado, United States
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  • Connecticut
    • Bristol, Connecticut, United States
      • Research Site
    • Waterbury, Connecticut, United States
      • Research Site
  • Florida
    • Bay Pines, Florida, United States
      • Research Site
    • Brandon, Florida, United States
      • Research Site
    • Clearwater, Florida, United States
      • Research Site
    • DeLand, Florida, United States
      • Research Site
    • Largo, Florida, United States
      • Research Site
    • Miami Beach, Florida, United States
      • Research Site
    • Naples, Florida, United States
      • Research Site
    • Ocala, Florida, United States
      • Research Site
    • Ormond Beach, Florida, United States
      • Research Site
    • Panama City, Florida, United States
      • Research Site
    • Pembroke Pines, Florida, United States
      • Research Site
    • Port Orange, Florida, United States
      • Research Site
    • Sarasota, Florida, United States
      • Research Site
  • Georgia
    • Blairsville, Georgia, United States
      • Research Site
    • Blue Ridge, Georgia, United States
      • Research Site
    • Marietta, Georgia, United States
      • Research Site
    • Rome, Georgia, United States
      • Research Site
  • Idaho
    • Coeur d'Alene, Idaho, United States
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  • Illinois
    • Bloomington, Illinois, United States
      • Research Site
    • Chicago, Illinois, United States
      • Research Site
    • Hines, Illinois, United States
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    • Normal, Illinois, United States
      • Research Site
    • North Chicago, Illinois, United States
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    • O'Fallon, Illinois, United States
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  • Indiana
    • Evansville, Indiana, United States
      • Research Site
    • South Bend, Indiana, United States
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  • Iowa
    • Iowa City, Iowa, United States
      • Research Site
    • Waterloo, Iowa, United States
      • Research Site
  • Kansas
    • Mission, Kansas, United States
      • Research Site
    • Wichita, Kansas, United States
      • Research Site
  • Kentucky
    • Lebanon, Kentucky, United States
      • Research Site
    • Louisville, Kentucky, United States
      • Research Site
    • Madisonville, Kentucky, United States
      • Research Site
    • Paducah, Kentucky, United States
      • Research Site
  • Louisiana
    • Baton Rouge, Louisiana, United States
      • Research Site
    • Lafayette, Louisiana, United States
      • Research Site
    • Marrero, Louisiana, United States
      • Research Site
    • New Orleans, Louisiana, United States
      • Research Site
    • Shreveport, Louisiana, United States
      • Research Site
    • Sunset, Louisiana, United States
      • Research Site
  • Maine
    • Auburn, Maine, United States
      • Research Site
    • Bangor, Maine, United States
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States
      • Research Site
  • Massachusetts
    • Taunton, Massachusetts, United States
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States
      • Research Site
    • Plymouth, Minnesota, United States
      • Research Site
    • St Paul, Minnesota, United States
      • Research Site
  • Missouri
    • Chesterfield, Missouri, United States
      • Research Site
    • St. Charles, Missouri, United States
      • Research Site
    • St. Louis, Missouri, United States
      • Research Site
  • Montana
    • Butte, Montana, United States
      • Research Site
    • Missoula, Montana, United States
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States
      • Research Site
    • Papillion, Nebraska, United States
      • Research Site
    • Scottsbluff, Nebraska, United States
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States
      • Research Site
    • Pahrump, Nevada, United States
      • Research Site
    • Reno, Nevada, United States
      • Research Site
  • New Jersey
    • Cherry Hill, New Jersey, United States
      • Research Site
    • Skillman, New Jersey, United States
      • Research Site
    • Springfield, New Jersey, United States
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Research Site
  • New York
    • Bay Shore, New York, United States
      • Research Site
    • Buffalo, New York, United States
      • Research Site
    • Larchmont, New York, United States
      • Research Site
    • Mineola, New York, United States
      • Research Site
    • New York, New York, United States
      • Research Site
    • Rochester, New York, United States
      • Research Site
  • North Carolina
    • Chapel Hill, North Carolina, United States
      • Research Site
    • Raleigh, North Carolina, United States
      • Research Site
    • Winston-Salem, North Carolina, United States
      • Research Site
  • North Dakota
    • Bismarck, North Dakota, United States
      • Research Site
  • Ohio
    • Akron, Ohio, United States
      • Research Site
    • Cincinnati, Ohio, United States
      • Research Site
    • Cleveland, Ohio, United States
      • Research Site
    • Mogadore, Ohio, United States
      • Research Site
    • Sylvania, Ohio, United States
      • Research Site
    • Zanesville, Ohio, United States
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Research Site
  • Oregon
    • Eugene, Oregon, United States
      • Research Site
    • Medford, Oregon, United States
      • Research Site
    • Portland, Oregon, United States
      • Research Site
  • Pennsylvania
    • Easton, Pennsylvania, United States
      • Research Site
    • Erie, Pennsylvania, United States
      • Research Site
    • Hershey, Pennsylvania, United States
      • Research Site
    • Philadelphia, Pennsylvania, United States
      • Research Site
    • Pittsburgh, Pennsylvania, United States
      • Research Site
    • Ridley Park, Pennsylvania, United States
      • Research Site
    • Swarthmore, Pennsylvania, United States
      • Research Site
    • West Chester, Pennsylvania, United States
      • Research Site
  • Rhode Island
    • East Providence, Rhode Island, United States
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States
      • Research Site
    • Simpsonville, South Carolina, United States
      • Research Site
    • Spartanburg, South Carolina, United States
      • Research Site
  • Texas
    • Austin, Texas, United States
      • Research Site
    • Barker, Texas, United States
      • Research Site
    • Dallas, Texas, United States
      • Research Site
    • El Paso, Texas, United States
      • Research Site
    • Fort Worth, Texas, United States
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    • Houston, Texas, United States
      • Research Site
    • Killeen, Texas, United States
      • Research Site
    • New Braunfels, Texas, United States
      • Research Site
    • San Antonio, Texas, United States
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  • Virginia
    • Abingdon, Virginia, United States
      • Research Site
    • Charlottesville, Virginia, United States
      • Research Site
    • Richmond, Virginia, United States
      • Research Site
    • Salem, Virginia, United States
      • Research Site
    • Virginia Beach, Virginia, United States
      • Research Site
  • Washington
    • Bellingham, Washington, United States
      • Research Site
    • Seattle, Washington, United States
      • Research Site
    • Spokane, Washington, United States
      • Research Site
    • Tacoma, Washington, United States
      • Research Site
  • Wisconsin
    • La Crosse, Wisconsin, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
- all variables assessed over the 6 months treatment period
Health care utilization
Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
Pharmacokinetics (subgroup)
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): March 27, 2009
• Last Update Submitted That Met QC Criteria: March 26, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate
• Other Study ID Numbers: D5899C00002; EurodraCT No: 2004-001183-41