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| ID | Type | Description | Link |
|---|---|---|---|
| EurodraCT No: 2004-001183-41 |
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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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol pMDI | Drug | |||
| Budesonide pMDI | Drug | |||
| Formoterol Turbuhaler | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries | ||
| Health care utilization | ||
| Pharmacokinetics (subgroup) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Symbicort Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29331313 | Derived | 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. | |
| 25670896 |
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| Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry. |
| - all variables assessed over the 6 months treatment period |
| Jasper |
| Alabama |
| United States |
| Research Site | Mobile | Alabama | United States |
| Research Site | Glendale | Arizona | United States |
| Research Site | Mesa | Arizona | United States |
| Research Site | Phoenix | Arizona | United States |
| Research Site | Fort Smith | Arkansas | United States |
| Research Site | Little Rock | Arkansas | United States |
| Research Site | Searcy | Arkansas | United States |
| Research Site | 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 Springs | Colorado | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Wheat Ridge | Colorado | United States |
| Research Site | Bristol | Connecticut | United States |
| Research Site | Waterbury | Connecticut | United States |
| Research Site | 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 | 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 | Coeur d'Alene | Idaho | United States |
| Research Site | Bloomington | Illinois | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Hines | Illinois | United States |
| Research Site | Normal | Illinois | United States |
| Research Site | North Chicago | Illinois | United States |
| Research Site | O'Fallon | Illinois | United States |
| Research Site | Evansville | Indiana | United States |
| Research Site | South Bend | Indiana | United States |
| Research Site | Iowa City | Iowa | United States |
| Research Site | Waterloo | Iowa | United States |
| Research Site | Mission | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Lebanon | Kentucky | United States |
| Research Site | Louisville | Kentucky | United States |
| Research Site | Madisonville | Kentucky | United States |
| Research Site | Paducah | Kentucky | United States |
| Research Site | 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 | Auburn | Maine | United States |
| Research Site | Bangor | Maine | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Taunton | Massachusetts | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | Plymouth | Minnesota | United States |
| Research Site | Saint Paul | Minnesota | United States |
| Research Site | Chesterfield | Missouri | United States |
| Research Site | Saint Charles | Missouri | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Butte | Montana | United States |
| Research Site | Missoula | Montana | United States |
| Research Site | Omaha | Nebraska | United States |
| Research Site | Papillion | Nebraska | United States |
| Research Site | Scottsbluff | Nebraska | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Pahrump | Nevada | United States |
| Research Site | Reno | Nevada | United States |
| Research Site | Cherry Hill | New Jersey | United States |
| Research Site | Skillman | New Jersey | United States |
| Research Site | Springfield | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | 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 | Chapel Hill | North Carolina | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Bismarck | North Dakota | United States |
| Research Site | 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 City | Oklahoma | United States |
| Research Site | Eugene | Oregon | United States |
| Research Site | Medford | Oregon | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | 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 | East Providence | Rhode Island | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Simpsonville | South Carolina | United States |
| Research Site | Spartanburg | South Carolina | United States |
| Research Site | 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 |
| Research Site | Houston | Texas | United States |
| Research Site | Killeen | Texas | United States |
| Research Site | New Braunfels | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | 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 | Bellingham | Washington | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Spokane | Washington | United States |
| Research Site | Tacoma | Washington | United States |
| Research Site | La Crosse | Wisconsin | United States |
| Research Site | Prague | CZ | Czechia |
| Research Site | Ústí nad Labem | CZ | Czechia |
| Research Site | Beroun | Czechia |
| Research Site | Cvikov | Czechia |
| Research Site | Jarom¿¿ | Czechia |
| Research Site | Karlovy Vary | Czechia |
| Research Site | Kladno | Czechia |
| Research Site | Kutná Hora | Czechia |
| Research Site | Liberec | Czechia |
| Research Site | Lovosice | Czechia |
| Research Site | Neratovice | Czechia |
| Research Site | Olomouc | Czechia |
| Research Site | Ostrava | Czechia |
| Research Site | Pilsen | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Rokycany | Czechia |
| Research Site | Strakonice | Czechia |
| Research Site | Ústí nad Labem | Czechia |
| Research Site | Znojmo | Czechia |
| Research Site | Almelo | Netherlands |
| Research Site | Arnhem | Netherlands |
| Research Site | Breda | Netherlands |
| Research Site | Eindhoven | Netherlands |
| Research Site | Groningen | Netherlands |
| Research Site | Harderwijk | Netherlands |
| Research Site | Heerlen | Netherlands |
| Research Site | Nieuwegein | Netherlands |
| Research Site | Terneuzen | Netherlands |
| Research Site | The Hague | Netherlands |
| Research Site | Tilburg | Netherlands |
| Research Site | Utrecht | Netherlands |
| Research Site | Bia¿ystok | Poland |
| Research Site | Bydgoszcz | Poland |
| Research Site | Bystra ¿l¿ska | Poland |
| Research Site | Chrzanów | Poland |
| Research Site | Ch¿ciny | Poland |
| Research Site | Cz¿stochowa | Poland |
| Research Site | Gidle | Poland |
| Research Site | Gorzów Wlkp | Poland |
| Research Site | I¿awa | Poland |
| Research Site | Karpacz | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lublin | Poland |
| Research Site | Ostrów Wielkopolski | Poland |
| Research Site | Otowck | Poland |
| Research Site | Późna | Poland |
| Research Site | Proszowice | Poland |
| Research Site | Radom | Poland |
| Research Site | Siedlce | Poland |
| Research Site | Sopot | Poland |
| Research Site | Szczecin | Poland |
| Research Site | Tarnów | Poland |
| Research Site | Turek | Poland |
| Research Site | Warsaw | 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 | Parow | Cape Province | South Africa |
| Research Site | Lenasia | Gauteng | South Africa |
| Research Site | Pretoria | Gauteng | South Africa |
| Research Site | Witbank | Gauteng | South Africa |
| Research Site | Cape Town | Western Cape | South Africa |
| Research Site | Cape Town | South Africa |
| Research Site | Durban | South Africa |
| Research Site | eMkhomazi | South Africa |
| Research Site | Lyttelton Manor | South Africa |
| Research Site | Port Elizabeth | South Africa |
| 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. |
| 22383665 | Derived | 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. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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