Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
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
| Verified date | March 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 1600 |
| Est. completion date | September 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Research Site | Pleven | |
| Bulgaria | Research Site | Plovdiv | |
| Bulgaria | Research Site | Rousse | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Varna | |
| Denmark | 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 | Kobenhavn N | |
| Denmark | Research Site | Kobenhavn NV | |
| Denmark | Research Site | Kobenhavn S. | |
| Denmark | Research Site | Silkeborg | |
| Denmark | Research Site | Skive | |
| Denmark | Research Site | Svendborg | |
| Denmark | Research Site | Vaerlose | |
| Denmark | Research Site | Viborg | |
| 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 | Cottbus | Brandenburg |
| Germany | Research Site | Dresden | Sachsen |
| Germany | Research Site | Dusseldorf | Nordrhein-Westfalen |
| Germany | Research Site | Erfurt | |
| Germany | Research Site | Frankfurt | |
| Germany | Research Site | Freiburg | |
| Germany | Research Site | Geesthacht | |
| Germany | Research Site | Gelnhausen | |
| Germany | Research Site | Gelsenkirchen | |
| Germany | Research Site | Grobhansdorf | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Jena-Maua | Thüringen |
| Germany | Research Site | Kassel | |
| Germany | Research Site | Koln | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Mainz | |
| Germany | Research Site | Marburg | |
| Germany | Research Site | München | |
| Germany | Research Site | Münster | Nordrhein-Westfalen |
| Germany | Research Site | Neuruppin | |
| Germany | Research Site | Potsdam | |
| Greece | Research Site | Athens | |
| Greece | Research Site | Hraklion- Crete | |
| Greece | Research Site | Larisa | |
| Greece | Research Site | Thessaloniki | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Cegled | |
| Hungary | Research Site | Deszk | |
| Hungary | Research Site | Erd | |
| Hungary | Research Site | Fuzesabony | |
| Hungary | Research Site | Godolli | |
| Hungary | Research Site | Gyöngyös | |
| Hungary | Research Site | Gyor | |
| Hungary | Research Site | Gyula | |
| Hungary | Research Site | Jaszbereny | |
| Hungary | Research Site | Keszthely | |
| Hungary | Research Site | Kiskunhalas | |
| Hungary | Research Site | Mosdos | |
| Hungary | Research Site | Mosonmagyarovar | |
| Hungary | Research Site | Nógrádgárdony | |
| Hungary | Research Site | Pecs | |
| Hungary | Research Site | Salgótarján | |
| Hungary | Research Site | Sárvár | |
| Hungary | Research Site | Siofok | |
| Hungary | Research Site | Szarvas | |
| Hungary | Research Site | Szazhalombatta | |
| Hungary | Research Site | Szeged | |
| Hungary | Research Site | Szombathely | |
| Hungary | Research Site | Tatabanya | |
| Hungary | Research Site | Törökbálint | |
| Hungary | Research Site | Veszprem | |
| Hungary | Research Site | Zalaegerszeg | |
| Hungary | Research Site | Zalaegerszeg-Pozva | |
| Iceland | Research Site | Reykjavik | |
| Mexico | Research Site | Guadalajara | Jalisco |
| Mexico | Research Site | Mexico City | D.f. |
| Mexico | Research Site | Monterrey | Nuevo León |
| Romania | Research Site | Brasov | |
| Romania | Research Site | Bucharest | |
| Romania | Research Site | Deva | |
| Romania | Research Site | Iasi | |
| United States | Research Site | Abingdon | Virginia |
| United States | Research Site | Albany | New York |
| United States | Research Site | Allentown | Pennsylvania |
| United States | Research Site | Anderson | South Carolina |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Auburn | Maine |
| United States | Research Site | Avon | Indiana |
| United States | Research Site | Bangor | Maine |
| United States | Research Site | Bay Pines | Florida |
| United States | Research Site | Beaver | Pennsylvania |
| United States | Research Site | Berlin | New Jersey |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Blue Ridge | Georgia |
| United States | Research Site | Bowling Green | Kentucky |
| United States | Research Site | Cadillac | Michigan |
| United States | Research Site | Carmichael | California |
| United States | Research Site | Chardon | Ohio |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Cherry Hill | New Jersey |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Conyers | Georgia |
| United States | Research Site | Corsicana | Texas |
| United States | Research Site | Cortland | New York |
| United States | Research Site | Council Bluffs | Iowa |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Decatur | Georgia |
| United States | Research Site | Deland | Florida |
| United States | Research Site | Downingtown | Pennsylvania |
| United States | Research Site | East Providence | Rhode Island |
| United States | Research Site | Edina | Minnesota |
| United States | Research Site | El Paso | Texas |
| United States | Research Site | Elk Grove Village | Illinois |
| United States | Research Site | Elmira | New York |
| United States | Research Site | Elverson | Pennsylvania |
| United States | Research Site | Evansville | Indiana |
| United States | Research Site | Fort Smith | Arkansas |
| United States | Research Site | Fort Worth | Texas |
| 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 | Hartford | Connecticut |
| United States | Research Site | Henderson | Nevada |
| United States | Research Site | High Point | North Carolina |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Ithaca | New York |
| United States | Research Site | Jasper | Alabama |
| United States | Research Site | Kenner | Louisiana |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | La Jolla | California |
| United States | Research Site | Lafayette | Louisiana |
| United States | Research Site | Lakewood | California |
| United States | Research Site | Largo | Florida |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lebanon | Kentucky |
| United States | Research Site | Longwood | Florida |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Marietta | Georgia |
| United States | Research Site | McCook | Nebraska |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Mesa | Arizona |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Missoula | Montana |
| United States | Research Site | Mogadore | Ohio |
| United States | Research Site | Murrieta | California |
| United States | Research Site | Muscle Shoals | Alabama |
| United States | Research Site | New Hyde Park | New York |
| United States | Research Site | New Port Richey | Florida |
| United States | Research Site | Normal | Illinois |
| United States | Research Site | North Chicago | Illinois |
| United States | Research Site | O'Fallon | Illinois |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Ormond Beach | Florida |
| United States | Research Site | Pahrump | Nevada |
| United States | Research Site | Palo Alto | California |
| United States | Research Site | Panama City | Florida |
| United States | Research Site | Peninsula | California |
| United States | Research Site | Peoria | Illinois |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Pismo Beach | California |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Portage | Michigan |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Providence | Rhode Island |
| United States | Research Site | Provo | Utah |
| United States | Research Site | Rancho Mirage | California |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Riverside | California |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Sacramento | California |
| United States | Research Site | Saginaw | Michigan |
| United States | Research Site | Salt Lake City | Utah |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Santa Ana | California |
| United States | Research Site | Scottsbluff | Nebraska |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Slidell | Louisiana |
| United States | Research Site | South Bend | Indiana |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Springfield | Illinois |
| United States | Research Site | St. Charles | Missouri |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | Stockbridge | Georgia |
| United States | Research Site | Stockton | California |
| United States | Research Site | Swarthmore | Pennsylvania |
| United States | Research Site | Tamarac | Florida |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Taunton | Massachusetts |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Tonawanda | New York |
| United States | Research Site | Tucson | Arizona |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Turnersville | New Jersey |
| United States | Research Site | Union | South Carolina |
| United States | Research Site | Upland | Pennsylvania |
| United States | Research Site | Walnut Creek | California |
| United States | Research Site | Waterloo | Iowa |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Bulgaria, Denmark, Germany, Greece, Hungary, Iceland, Mexico, Romania,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period | |||
| Secondary | Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries | |||
| Secondary | Health care utilization | |||
| Secondary | Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry. | |||
| Secondary | all variables assessed over the 12 months treatment period |
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