Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EurodraCT No: 2004-001 168-28 | |||
| SUN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol pMDI | Drug | |||
| Formoterol Turbuhaler | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries | ||
| Health care utilization | ||
| Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| all variables assessed over the 12 months treatment period |
| Huntsville |
| Alabama |
| United States |
| Research Site | Jasper | Alabama | United States |
| Research Site | Muscle Shoals | Alabama | United States |
| Research Site | Mesa | Arizona | United States |
| Research Site | Phoenix | Arizona | United States |
| Research Site | Tucson | Arizona | United States |
| Research Site | Fort Smith | Arkansas | United States |
| Research Site | Carmichael | California | United States |
| Research Site | La Jolla | California | United States |
| Research Site | Lakewood | California | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Murrieta | California | United States |
| Research Site | Palo Alto | California | United States |
| Research Site | Peninsula | California | United States |
| Research Site | Pismo Beach | California | United States |
| Research Site | Rancho Mirage | California | United States |
| Research Site | Riverside | California | United States |
| Research Site | Sacramento | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Santa Ana | California | United States |
| Research Site | Stockton | California | United States |
| Research Site | Walnut Creek | California | United States |
| Research Site | Colorado Springs | Colorado | United States |
| Research Site | Hartford | Connecticut | United States |
| Research Site | Bay Pines | Florida | United States |
| Research Site | Clearwater | Florida | United States |
| Research Site | DeLand | Florida | United States |
| Research Site | Largo | Florida | United States |
| Research Site | Longwood | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | New Port Richey | Florida | United States |
| Research Site | Ormond Beach | Florida | United States |
| Research Site | Panama City | Florida | United States |
| Research Site | Tamarac | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Blue Ridge | Georgia | United States |
| Research Site | Conyers | Georgia | United States |
| Research Site | Decatur | Georgia | United States |
| Research Site | Marietta | Georgia | United States |
| Research Site | Stockbridge | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Elk Grove Village | 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 | Peoria | Illinois | United States |
| Research Site | Springfield | Illinois | United States |
| Research Site | Avon | Indiana | United States |
| Research Site | Evansville | Indiana | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | South Bend | Indiana | United States |
| Research Site | Council Bluffs | Iowa | United States |
| Research Site | Iowa City | Iowa | United States |
| Research Site | Waterloo | Iowa | United States |
| Research Site | Bowling Green | Kentucky | United States |
| Research Site | Lebanon | Kentucky | United States |
| Research Site | Louisville | Kentucky | United States |
| Research Site | Kenner | Louisiana | United States |
| Research Site | Lafayette | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Slidell | Louisiana | United States |
| Research Site | Auburn | Maine | United States |
| Research Site | Bangor | Maine | United States |
| Research Site | Taunton | Massachusetts | United States |
| Research Site | Cadillac | Michigan | United States |
| Research Site | Portage | Michigan | United States |
| Research Site | Saginaw | Michigan | United States |
| Research Site | Edina | Minnesota | United States |
| Research Site | Minneapolis | Minnesota | United States |
| Research Site | Saint Charles | Missouri | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Missoula | Montana | United States |
| Research Site | McCook | Nebraska | United States |
| Research Site | Omaha | Nebraska | United States |
| Research Site | Scottsbluff | Nebraska | United States |
| Research Site | Henderson | Nevada | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Pahrump | Nevada | United States |
| Research Site | Berlin | New Jersey | United States |
| Research Site | Cherry Hill | New Jersey | United States |
| Research Site | Turnersville | New Jersey | United States |
| Research Site | Albany | New York | United States |
| Research Site | Cortland | New York | United States |
| Research Site | Elmira | New York | United States |
| Research Site | 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 | High Point | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | 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 |
| Research Site | Youngstown | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Tulsa | Oklahoma | United States |
| Research Site | Medford | Oregon | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Allentown | Pennsylvania | United States |
| Research Site | Beaver | Pennsylvania | United States |
| Research Site | Downingtown | Pennsylvania | United States |
| Research Site | Elverson | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Pittsburgh | Pennsylvania | United States |
| Research Site | Swarthmore | Pennsylvania | United States |
| Research Site | Upland | Pennsylvania | United States |
| Research Site | East Providence | Rhode Island | United States |
| Research Site | Providence | Rhode Island | United States |
| Research Site | Anderson | South Carolina | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Gaffney | South Carolina | United States |
| Research Site | Greenville | South Carolina | United States |
| Research Site | Greer | South Carolina | United States |
| Research Site | Spartanburg | South Carolina | United States |
| Research Site | Union | South Carolina | United States |
| Research Site | Knoxville | Tennessee | United States |
| Research Site | Corsicana | 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 | San Antonio | Texas | United States |
| Research Site | Provo | Utah | United States |
| Research Site | Salt Lake City | Utah | United States |
| Research Site | Abingdon | Virginia | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Spokane | Washington | United States |
| Research Site | Pleven | Bulgaria |
| Research Site | Plovdiv | Bulgaria |
| Research Site | Rousse | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Varna | Bulgaria |
| Research Site | Aalborg | Denmark |
| Research Site | Christiansfeld | Denmark |
| Research Site | Frederikshavn | Denmark |
| Research Site | Frederikssund | Denmark |
| Research Site | Hellerup | Denmark |
| Research Site | Kobenhavn K | Denmark |
| Research Site | København N | Denmark |
| Research Site | København NV | Denmark |
| Research Site | København S | Denmark |
| Research Site | Silkeborg | Denmark |
| Research Site | Skive | Denmark |
| Research Site | Svendborg | Denmark |
| Research Site | Viborg | Denmark |
| Research Site | Værløse | Denmark |
| Research Site | Cottbus | Brandenburg | Germany |
| Research Site | Düsseldorf | North Rhine-Westphalia | Germany |
| Research Site | Münster | North Rhine-Westphalia | Germany |
| Research Site | Dresden | Saxony | Germany |
| Research Site | Jena-Maua | Thuringia | Germany |
| Research Site | Bad Salzungen | Germany |
| Research Site | Bad Segeberg | Germany |
| Research Site | Berlin | Germany |
| Research Site | Bochum | Germany |
| Research Site | Bonn | Germany |
| Research Site | Cologne | Germany |
| Research Site | Erfurt | Germany |
| Research Site | Frankfurt | Germany |
| Research Site | Freiburg im Breisgau | Germany |
| Research Site | Geesthacht | Germany |
| Research Site | Gelnhausen | Germany |
| Research Site | Gelsenkirchen | Germany |
| Research Site | Grobhansdorf | Germany |
| Research Site | Hanover | Germany |
| Research Site | Kassel | Germany |
| Research Site | Leipzig | Germany |
| Research Site | Mainz | Germany |
| Research Site | Marburg | Germany |
| Research Site | München | Germany |
| Research Site | Neuruppin | Germany |
| Research Site | Potsdam | Germany |
| Research Site | Athens | Greece |
| Research Site | Hraklion- Crete | Greece |
| Research Site | Larissa | Greece |
| Research Site | Thessaloniki | Greece |
| Research Site | Budapest | Hungary |
| Research Site | Cegléd | Hungary |
| Research Site | Deszk | Hungary |
| Research Site | Érd | Hungary |
| Research Site | Füzesabony | Hungary |
| Research Site | Godolli | Hungary |
| Research Site | Gyöngyös | Hungary |
| Research Site | Győr | Hungary |
| Research Site | Gyula | Hungary |
| Research Site | Jászberény | Hungary |
| Research Site | Keszthely | Hungary |
| Research Site | Kiskunhalas | Hungary |
| Research Site | Mosdós | Hungary |
| Research Site | Mosonmagyaróvár | Hungary |
| Research Site | Nógrádgárdony | Hungary |
| Research Site | Pécs | Hungary |
| Research Site | Salgótarján | Hungary |
| Research Site | Sárvár | Hungary |
| Research Site | Siófok | Hungary |
| Research Site | Szarvas | Hungary |
| Research Site | Százhalombatta | Hungary |
| Research Site | Szeged | Hungary |
| Research Site | Szombathely | Hungary |
| Research Site | Tatabánya | Hungary |
| Research Site | Törökbálint | Hungary |
| Research Site | Veszprém | Hungary |
| Research Site | Zalaegerszeg | Hungary |
| Research Site | Zalaegerszeg-Pozva | Hungary |
| Research Site | Reykjavik | Iceland |
| Research Site | Mexico City | D.F. | Mexico |
| Research Site | Guadalajara | Jalisco | Mexico |
| Research Site | Monterrey | Nuevo León | Mexico |
| Research Site | Brasov | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Deva | Romania |
| Research Site | Iași | Romania |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided