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 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).

Study Overview

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

• Study Type: Interventional
• Enrollment: 1600
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria
    • Research Site
  • Plovdiv, Bulgaria
    • Research Site
  • Rousse, Bulgaria
    • Research Site
  • Sofia, Bulgaria
    • Research Site
  • Varna, Bulgaria
    • Research Site
• Denmark
  • Aalborg, Denmark
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  • Christiansfeld, Denmark
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  • Frederikshavn, Denmark
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  • Frederikssund, Denmark
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  • Hellerup, Denmark
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  • Kobenhavn K, Denmark
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  • Kobenhavn N, Denmark
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  • Kobenhavn NV, Denmark
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  • Kobenhavn S., Denmark
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  • Silkeborg, Denmark
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  • Skive, Denmark
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  • Svendborg, Denmark
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  • Vaerlose, Denmark
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  • Viborg, Denmark
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• Germany
  • Bad Salzungen, Germany
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  • Bad Segeberg, Germany
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  • Berlin, Germany
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  • Bochum, Germany
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  • Bonn, Germany
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  • Erfurt, Germany
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  • Frankfurt, Germany
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  • Freiburg, Germany
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  • Geesthacht, Germany
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  • Gelnhausen, Germany
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  • Gelsenkirchen, Germany
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  • Grobhansdorf, Germany
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  • Hannover, Germany
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  • Kassel, Germany
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  • Koln, Germany
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  • Leipzig, Germany
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  • Mainz, Germany
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  • Marburg, Germany
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  • München, Germany
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  • Neuruppin, Germany
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  • Potsdam, Germany
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  • Brandenburg
    • Cottbus, Brandenburg, Germany
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  • Nordrhein-Westfalen
    • Dusseldorf, Nordrhein-Westfalen, Germany
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    • Münster, Nordrhein-Westfalen, Germany
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  • Sachsen
    • Dresden, Sachsen, Germany
      • Research Site
  • Thüringen
    • Jena-Maua, Thüringen, Germany
      • Research Site
• Greece
  • Athens, Greece
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  • Hraklion- Crete, Greece
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  • Larisa, Greece
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  • Thessaloniki, Greece
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• Hungary
  • Budapest, Hungary
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  • Cegled, Hungary
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  • Deszk, Hungary
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  • Erd, Hungary
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  • Fuzesabony, Hungary
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  • Godolli, Hungary
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  • Gyor, Hungary
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  • Gyula, Hungary
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  • Gyöngyös, Hungary
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  • Jaszbereny, Hungary
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  • Keszthely, Hungary
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  • Kiskunhalas, Hungary
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  • Mosdos, Hungary
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  • Mosonmagyarovar, Hungary
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  • Nógrádgárdony, Hungary
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  • Pecs, Hungary
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  • Salgótarján, Hungary
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  • Siofok, Hungary
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  • Szarvas, Hungary
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  • Szazhalombatta, Hungary
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  • Szeged, Hungary
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  • Szombathely, Hungary
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  • Sárvár, Hungary
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  • Tatabanya, Hungary
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  • Törökbálint, Hungary
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  • Veszprem, Hungary
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  • Zalaegerszeg, Hungary
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  • Zalaegerszeg-Pozva, Hungary
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• Iceland
  • Reykjavik, Iceland
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• Mexico
  • D.f.
    • Mexico City, D.f., Mexico
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  • Jalisco
    • Guadalajara, Jalisco, Mexico
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  • Nuevo León
    • Monterrey, Nuevo León, Mexico
      • Research Site
• Romania
  • Brasov, Romania
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  • Bucharest, Romania
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  • Deva, Romania
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  • Iasi, Romania
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• United States
  • Alabama
    • Birmingham, Alabama, United States
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    • Huntsville, Alabama, United States
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    • Jasper, Alabama, United States
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    • Muscle Shoals, Alabama, United States
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  • Arizona
    • Mesa, Arizona, United States
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    • Phoenix, Arizona, United States
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    • Tucson, Arizona, United States
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  • Arkansas
    • Fort Smith, Arkansas, United States
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  • California
    • Carmichael, California, United States
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    • La Jolla, California, United States
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    • Lakewood, California, United States
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    • Los Angeles, California, United States
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    • Murrieta, California, United States
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    • Palo Alto, California, United States
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    • Peninsula, California, United States
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    • Pismo Beach, California, United States
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    • Rancho Mirage, California, United States
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    • Riverside, California, United States
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    • Sacramento, California, United States
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    • San Diego, California, United States
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    • Santa Ana, California, United States
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    • Stockton, California, United States
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    • Walnut Creek, California, United States
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  • Colorado
    • Colorado Springs, Colorado, United States
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  • Connecticut
    • Hartford, Connecticut, United States
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  • Florida
    • Bay Pines, Florida, United States
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    • Clearwater, Florida, United States
      • Research Site
    • Deland, Florida, United States
      • Research Site
    • Largo, Florida, United States
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    • Longwood, Florida, United States
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    • Miami, Florida, United States
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    • New Port Richey, Florida, United States
      • Research Site
    • Ormond Beach, Florida, United States
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    • Panama City, Florida, United States
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    • Tamarac, Florida, United States
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    • Tampa, Florida, United States
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  • Georgia
    • Atlanta, Georgia, United States
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    • Blue Ridge, Georgia, United States
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    • Conyers, Georgia, United States
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    • Decatur, Georgia, United States
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    • Marietta, Georgia, United States
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    • Stockbridge, Georgia, United States
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  • Illinois
    • Chicago, Illinois, United States
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    • Elk Grove Village, Illinois, United States
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    • Normal, Illinois, United States
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    • North Chicago, Illinois, United States
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    • O'Fallon, Illinois, United States
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    • Peoria, Illinois, United States
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    • Springfield, Illinois, United States
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  • Indiana
    • Avon, Indiana, United States
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    • Evansville, Indiana, United States
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    • Indianapolis, Indiana, United States
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    • South Bend, Indiana, United States
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  • Iowa
    • Council Bluffs, Iowa, United States
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    • Iowa City, Iowa, United States
      • Research Site
    • Waterloo, Iowa, United States
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  • Kentucky
    • Bowling Green, Kentucky, United States
      • Research Site
    • Lebanon, Kentucky, United States
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    • Louisville, Kentucky, United States
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  • Louisiana
    • Kenner, Louisiana, United States
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    • Lafayette, Louisiana, United States
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    • Shreveport, Louisiana, United States
      • Research Site
    • Slidell, Louisiana, United States
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  • Maine
    • Auburn, Maine, United States
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    • Bangor, Maine, United States
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  • Massachusetts
    • Taunton, Massachusetts, United States
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  • Michigan
    • Cadillac, Michigan, United States
      • Research Site
    • Portage, Michigan, United States
      • Research Site
    • Saginaw, Michigan, United States
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  • Minnesota
    • Edina, Minnesota, United States
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    • Minneapolis, Minnesota, United States
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  • Missouri
    • St. Charles, Missouri, United States
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    • St. Louis, Missouri, United States
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  • Montana
    • Missoula, Montana, United States
      • Research Site
  • Nebraska
    • McCook, Nebraska, United States
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    • Omaha, Nebraska, United States
      • Research Site
    • Scottsbluff, Nebraska, United States
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  • Nevada
    • Henderson, Nevada, United States
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    • Las Vegas, Nevada, United States
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    • Pahrump, Nevada, United States
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  • New Jersey
    • Berlin, New Jersey, United States
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    • Cherry Hill, New Jersey, United States
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    • Turnersville, New Jersey, United States
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  • New York
    • Albany, New York, United States
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    • Cortland, New York, United States
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    • Elmira, New York, United States
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    • Ithaca, New York, United States
      • Research Site
    • New Hyde Park, New York, United States
      • Research Site
    • Rochester, New York, United States
      • Research Site
    • Tonawanda, New York, United States
      • Research Site
  • North Carolina
    • High Point, North Carolina, United States
      • Research Site
    • Winston-Salem, North Carolina, United States
      • Research Site
  • Ohio
    • Chardon, Ohio, United States
      • Research Site
    • Cincinnati, Ohio, United States
      • Research Site
    • Cleveland, Ohio, United States
      • Research Site
    • Mogadore, Ohio, United States
      • Research Site
    • Toledo, Ohio, United States
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    • Youngstown, Ohio, United States
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States
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    • Tulsa, Oklahoma, United States
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  • Oregon
    • Medford, Oregon, United States
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    • Portland, Oregon, United States
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  • Pennsylvania
    • Allentown, Pennsylvania, United States
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    • Beaver, Pennsylvania, United States
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    • Downingtown, Pennsylvania, United States
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    • Elverson, Pennsylvania, United States
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    • Philadelphia, Pennsylvania, United States
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    • Pittsburgh, Pennsylvania, United States
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    • Swarthmore, Pennsylvania, United States
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    • Upland, Pennsylvania, United States
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  • Rhode Island
    • East Providence, Rhode Island, United States
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    • Providence, Rhode Island, United States
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  • South Carolina
    • Anderson, South Carolina, 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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    • Greer, 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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  • Tennessee
    • Knoxville, Tennessee, United States
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  • Texas
    • Corsicana, Texas, United States
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    • Dallas, Texas, United States
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    • El Paso, Texas, United States
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    • Fort Worth, Texas, United States
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    • Houston, Texas, United States
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    • San Antonio, Texas, United States
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  • Utah
    • Provo, Utah, United States
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    • Salt Lake City, Utah, United States
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  • Virginia
    • Abingdon, Virginia, United States
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    • Richmond, Virginia, United States
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  • Washington
    • Spokane, Washington, United States
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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 12 months treatment period

Secondary Outcome Measures

Outcome Measure
Health care utilization
Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries
Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry.
all variables assessed over the 12 months treatment period

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): September 1, 2007

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: D5899C00001; EurodraCT No: 2004-001 168-28; SUN