Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A 6-Month Double-Blind, Double-Dummy, Randomized, Parallel Group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg Bid Compared to Formoterol TBH, Budesonide pMDI (& the Combination) & Placebo in COPD Patients
| 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 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)
| Status | Completed |
| Enrollment | 1500 |
| Est. completion date | December 2006 |
| 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 |
|---|---|---|---|
| Czech Republic | Research Site | Beroun | |
| Czech Republic | Research Site | Cvikov | |
| Czech Republic | Research Site | Jarom¿¿ | |
| Czech Republic | Research Site | Karlovy Vary | |
| Czech Republic | Research Site | Kladno | |
| Czech Republic | Research Site | Kutná Hora | |
| Czech Republic | Research Site | Liberec | |
| Czech Republic | Research Site | Lovosice | |
| Czech Republic | Research Site | Neratovice | |
| Czech Republic | Research Site | Olomouc | |
| Czech Republic | Research Site | Ostrava 1 | |
| Czech Republic | Research Site | Plzen | |
| Czech Republic | Research Site | Praha 1 | |
| Czech Republic | Research Site | Praha 2 | |
| Czech Republic | Research Site | Praha 5 | |
| Czech Republic | Research Site | Praha 8 | |
| Czech Republic | Research Site | Praha 8 | CZ |
| Czech Republic | Research Site | Rokycany | |
| Czech Republic | Research Site | Strakonice | |
| Czech Republic | Research Site | Ústí nad Labem | CZ |
| Czech Republic | Research Site | Ústí nad Labem | |
| Czech Republic | Research Site | Znojmo | |
| Netherlands | Research Site | Almelo | |
| Netherlands | Research Site | Arnhem | |
| Netherlands | Research Site | Breda | |
| Netherlands | Research Site | Den Haag | |
| 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 | Tilburg | |
| Netherlands | Research Site | Utrecht | |
| Poland | Research Site | ¿ód¿ | |
| Poland | Research Site | ¿om¿a | |
| Poland | Research Site | Bia¿ystok | |
| Poland | Research Site | Bydgoszcz | |
| Poland | Research Site | Bystra ¿l¿ska | |
| Poland | Research Site | Ch¿ciny | |
| Poland | Research Site | Chrzanów | |
| 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 | Kraków | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Ostrów Wielkopolski | |
| Poland | Research Site | Otowck | |
| Poland | Research Site | Pozna¿ | |
| 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 | Warszawa | |
| Poland | Research Site | Wo¿omin | |
| Poland | Research Site | Zabrze | |
| Poland | Research Site | Zawadzkie | |
| South Africa | Research Site | Cape Town | Western Cape |
| South Africa | Research Site | Cape Town | |
| South Africa | Research Site | Durban | |
| South Africa | Research Site | Lenasia | Gauteng |
| South Africa | Research Site | Lyttelton Manor | |
| South Africa | Research Site | Parow | Cape Province |
| South Africa | Research Site | Port Elizabeth | |
| South Africa | Research Site | Pretoria | Gauteng |
| South Africa | Research Site | Umkomaas | |
| South Africa | Research Site | Witbank | Gauteng |
| United States | Research Site | Abingdon | Virginia |
| United States | Research Site | Akron | Ohio |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Auburn | Maine |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Bangor | Maine |
| United States | Research Site | Barker | Texas |
| United States | Research Site | Baton Rouge | Louisiana |
| United States | Research Site | Bay Pines | Florida |
| United States | Research Site | Bay Shore | New York |
| United States | Research Site | Bellingham | Washington |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Bismarck | North Dakota |
| United States | Research Site | Blairsville | Georgia |
| United States | Research Site | Bloomington | Illinois |
| United States | Research Site | Blue Ridge | Georgia |
| United States | Research Site | Brandon | Florida |
| United States | Research Site | Bristol | Connecticut |
| United States | Research Site | Buffalo | New York |
| United States | Research Site | Butte | Montana |
| United States | Research Site | Chapel Hill | North Carolina |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Charlottesville | Virginia |
| United States | Research Site | Cherry Hill | New Jersey |
| United States | Research Site | Chesterfield | Missouri |
| 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 | Coeur d'Alene | Idaho |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | DeLand | Florida |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | East Providence | Rhode Island |
| United States | Research Site | Easton | Pennsylvania |
| United States | Research Site | El Paso | Texas |
| United States | Research Site | Erie | Pennsylvania |
| United States | Research Site | Eugene | Oregon |
| United States | Research Site | Evansville | Indiana |
| United States | Research Site | Fort Smith | Arkansas |
| United States | Research Site | Fort Worth | Texas |
| United States | Research Site | Fullerton | California |
| United States | Research Site | Glendale | Arizona |
| United States | Research Site | Hershey | Pennsylvania |
| United States | Research Site | Hines | Illinois |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Irvine | California |
| United States | Research Site | Jasper | Alabama |
| United States | Research Site | Killeen | Texas |
| United States | Research Site | La Crosse | Wisconsin |
| United States | Research Site | Lafayette | Louisiana |
| United States | Research Site | Larchmont | New York |
| United States | Research Site | Largo | Florida |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lebanon | Kentucky |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Madisonville | Kentucky |
| United States | Research Site | Marietta | Georgia |
| United States | Research Site | Marrero | Louisiana |
| United States | Research Site | Medford | Oregon |
| United States | Research Site | Mesa | Arizona |
| United States | Research Site | Miami Beach | Florida |
| United States | Research Site | Mineola | New York |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Mission | Kansas |
| United States | Research Site | Mission Viejo | California |
| United States | Research Site | Missoula | Montana |
| United States | Research Site | Mobile | Alabama |
| United States | Research Site | Mogadore | Ohio |
| United States | Research Site | Naples | Florida |
| United States | Research Site | New Braunfels | Texas |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New York | New York |
| United States | Research Site | Normal | Illinois |
| United States | Research Site | North Chicago | Illinois |
| United States | Research Site | O'Fallon | Illinois |
| United States | Research Site | Ocala | Florida |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Orange | California |
| United States | Research Site | Ormond Beach | Florida |
| United States | Research Site | Paducah | Kentucky |
| United States | Research Site | Pahrump | Nevada |
| United States | Research Site | Panama City | Florida |
| United States | Research Site | Papillion | Nebraska |
| United States | Research Site | Pembroke Pines | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Plymouth | Minnesota |
| United States | Research Site | Port Orange | Florida |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Rancho Cordova | California |
| United States | Research Site | Reno | Nevada |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Ridley Park | Pennsylvania |
| United States | Research Site | Riverside | California |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Rome | Georgia |
| United States | Research Site | Salem | Virginia |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Jose | California |
| United States | Research Site | Sarasota | Florida |
| United States | Research Site | Scottsbluff | Nebraska |
| United States | Research Site | Searcy | Arkansas |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Sepulveda | California |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Signal Hill | California |
| United States | Research Site | Simpsonville | South Carolina |
| United States | Research Site | Skillman | New Jersey |
| 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 | New Jersey |
| United States | Research Site | St Paul | Minnesota |
| United States | Research Site | St. Charles | Missouri |
| United States | Research Site | St. Louis | Missouri |
| United States | Research Site | Stockton | California |
| United States | Research Site | Sunset | Louisiana |
| United States | Research Site | Swarthmore | Pennsylvania |
| United States | Research Site | Sylvania | Ohio |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Taunton | Massachusetts |
| United States | Research Site | Torrance | California |
| United States | Research Site | Virginia Beach | Virginia |
| United States | Research Site | Walnut Creek | California |
| United States | Research Site | Waterbury | Connecticut |
| United States | Research Site | Waterloo | Iowa |
| United States | Research Site | West Chester | Pennsylvania |
| United States | Research Site | Wheat Ridge | Colorado |
| United States | Research Site | Wichita | Kansas |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Czech Republic, Netherlands, Poland, South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period | |||
| Secondary | Patient-reported outcome variables regarding disease status (incl. PEF), collected via questionnaires and diaries | |||
| Secondary | Health care utilization | |||
| Secondary | Pharmacokinetics (subgroup) | |||
| Secondary | Safety variables, including adverse events, vital signs, ECG, physical examination, hematology, and clinical chemistry. | |||
| Secondary | - all variables assessed over the 6 months treatment period |
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