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

NCT ID: NCT00206167

Last Updated: 2009-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Budesonide/formoterol pMDI

Intervention Type DRUG

Formoterol Turbuhaler

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Symbicort Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Fort Smith, Arkansas, United States

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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 Springs, Colorado, United States

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Hartford, Connecticut, United States

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Bay Pines, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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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

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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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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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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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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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Council Bluffs, Iowa, United States

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Iowa City, Iowa, United States

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Waterloo, Iowa, United States

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Bowling Green, Kentucky, United States

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Lebanon, Kentucky, United States

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Louisville, Kentucky, United States

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Kenner, Louisiana, United States

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Lafayette, Louisiana, United States

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Shreveport, Louisiana, United States

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Slidell, Louisiana, United States

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Auburn, Maine, United States

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Bangor, Maine, United States

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Taunton, Massachusetts, United States

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Cadillac, Michigan, United States

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Portage, Michigan, United States

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Saginaw, Michigan, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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McCook, Nebraska, United States

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Omaha, Nebraska, United States

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Scottsbluff, Nebraska, United States

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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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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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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

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New Hyde Park, New York, United States

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Rochester, New York, United States

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Tonawanda, New York, United States

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High Point, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Chardon, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Mogadore, Ohio, United States

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Toledo, Ohio, United States

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Youngstown, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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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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East Providence, Rhode Island, United States

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Providence, Rhode Island, United States

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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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Knoxville, Tennessee, United States

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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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Provo, Utah, United States

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Salt Lake City, Utah, United States

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Abingdon, Virginia, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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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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København N, , Denmark

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København NV, , Denmark

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København S, , Denmark

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Silkeborg, , Denmark

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Skive, , Denmark

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Svendborg, , Denmark

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Viborg, , Denmark

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Værløse, , Denmark

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Cottbus, Brandenburg, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Münster, North Rhine-Westphalia, Germany

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Dresden, Saxony, Germany

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Jena-Maua, Thuringia, Germany

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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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Cologne, , Germany

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Erfurt, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , 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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Hanover, , Germany

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Kassel, , 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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Athens, , Greece

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Hraklion- Crete, , Greece

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Larissa, , Greece

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Thessaloniki, , Greece

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Budapest, , Hungary

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Cegléd, , Hungary

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Deszk, , Hungary

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Érd, , Hungary

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Füzesabony, , Hungary

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Godolli, , Hungary

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Gyöngyös, , Hungary

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Győr, , Hungary

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Gyula, , Hungary

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Jászberény, , Hungary

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Keszthely, , Hungary

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Kiskunhalas, , Hungary

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Mosdós, , Hungary

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Mosonmagyaróvár, , Hungary

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Nógrádgárdony, , Hungary

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Pécs, , Hungary

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Salgótarján, , Hungary

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Sárvár, , Hungary

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Siófok, , Hungary

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Szarvas, , Hungary

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Százhalombatta, , Hungary

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Szeged, , Hungary

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Szombathely, , Hungary

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Tatabánya, , Hungary

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Törökbálint, , Hungary

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Veszprém, , Hungary

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Zalaegerszeg, , Hungary

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Zalaegerszeg-Pozva, , Hungary

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Reykjavik, , Iceland

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Mexico City, D.F., Mexico

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Brasov, , Romania

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Bucharest, , Romania

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Deva, , Romania

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Iași, , Romania

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Countries

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United States Bulgaria Denmark Germany Greece Hungary Iceland Mexico Romania

References

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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.

Reference Type DERIVED
PMID: 29331313 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25670896 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22383665 (View on PubMed)

Other Identifiers

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EurodraCT No: 2004-001 168-28

Identifier Type: -

Identifier Source: secondary_id

SUN

Identifier Type: -

Identifier Source: secondary_id

D5899C00001

Identifier Type: -

Identifier Source: org_study_id

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