Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study
| Verified date | June 2011 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The aim of the study is to compare the effect of roflumilast on exacerbation rate and
pulmonary function in patients with chronic obstructive pulmonary disease (COPD).
Roflumilast will be administered orally once daily in the morning at one dose level. The
study duration will be up to 56 weeks. The study will provide further data on safety and
tolerability of roflumilast.
For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673
(toll free).
| Status | Completed |
| Enrollment | 1568 |
| Est. completion date | August 2008 |
| Est. primary completion date | April 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Main Inclusion Criteria: - COPD patients having at least one exacerbation within last year - FEV1/FVC ratio (post-bronchodilator) = 70% - FEV1 (post-bronchodilator) = 50% of predicted Main Exclusion Criteria: - COPD exacerbation not resolved at first baseline visit - Diagnosis of asthma and/or other relevant lung disease |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Altana Pharma/Nycomed Investigational Site | Antigonish | |
| Canada | Altana Pharma/Nycomed Investigational Site | Bridgewater | |
| Canada | Altana Pharma/Nycomed Investigational Site | Burnaby | British Columbia |
| Canada | Altana Pharma/Nycomed Investigational Site | Calgary | Alberta |
| Canada | Altana Pharma/Nycomed Investigational Site | Calgary | Alberta |
| Canada | Altana Pharma/Nycomed Investigational Site | Calgary | |
| Canada | Altana Pharma/Nycomed Investigational Site | Chatham | Ontario |
| Canada | Altana Pharma/Nycomed Investigational Site | Corunna | |
| Canada | Altana Pharma/Nycomed Investigational Site | Edmonton | |
| Canada | Altana Pharma/Nycomed Investigational Site | Edmonton | Alberta |
| Canada | Altana Pharma/Nycomed Investigational Site | Fort Erie | |
| Canada | Altana Pharma/Nycomed Investigational Site | Grimsby | |
| Canada | Altana Pharma/Nycomed Investigational Site | Hamilton | |
| Canada | Altana Pharma/Nycomed Investigational Site | Hamilton | Ontario |
| Canada | Altana Pharma/Nycomed Investigational Site | London | Ontario |
| Canada | Altana Pharma/Nycomed Investigational Site | Longueuil | |
| Canada | Altana Pharma/Nycomed Investigational Site | Mississauga | Ontario |
| Canada | Altana Pharma/Nycomed Investigational Site | Montreal | |
| Canada | Altana Pharma/Nycomed Investigational Site | Montreal | Quebec |
| Canada | Altana Pharma/Nycomed Investigational Site | Montreal | Quebec |
| Canada | Altana Pharma/Nycomed Investigational Site | Ontario | |
| Canada | Altana Pharma/Nycomed Investigational Site | Ottawa | Ontario |
| Canada | Altana Pharma/Nycomed Investigational Site | Penticton | British Columbia |
| Canada | Altana Pharma/Nycomed Investigational Site | Richmond Hill | |
| Canada | Altana Pharma/Nycomed Investigational Site | Saint John | |
| Canada | Altana Pharma/Nycomed Investigational Site | Sainte-Foy | Quebec |
| Canada | Altana Pharma/Nycomed Investigational Site | Sarnia | Ontario |
| Canada | Altana Pharma/Nycomed Investigational Site | Scarborough | Ontario |
| Canada | Altana Pharma/Nycomed Investigational Site | Sherbrooke | Quebec |
| Canada | Altana Pharma/Nycomed Investigational Site | Sherbrooke | |
| Canada | Altana Pharma/Nycomed Investigational Site | Spruce Grove | Alberta |
| Canada | Altana Pharma/Nycomed Investigational Site | St Jerome | |
| Canada | Altana Pharma/Nycomed Investigational Site | St Leonard | |
| Canada | Altana Pharma/Nycomed Investigational Site | St. Romuald | Quebec |
| Canada | Altana Pharma/Nycomed Investigational Site | Ste-Foy | Quebec |
| Canada | Altana Pharma/Nycomed Investigational Site | Toronto | |
| Canada | Altana Pharma/Nycomed Investigational Site | Toronto | Ontario |
| Canada | Altana Pharma/Nycomed Investigational Site | Truro | Nova Scotia |
| Canada | Altana Pharma/Nycomed Investigational Site | Vancouver | British Columbia |
| Canada | Altana Pharma/Nycomed Investigational Site | Winnipeg | |
| Germany | Altana Pharma/Nycomed Investigational Site | Berlin | |
| Germany | Altana Pharma/Nycomed Investigational Site | Berlin | |
| Germany | Altana Pharma/Nycomed Investigational Site | Berlin | |
| Germany | Altana Pharma/Nycomed Investigational Site | Berlin | |
| Germany | Altana Pharma/Nycomed Investigational Site | Berlin | |
| Germany | Altana Pharma/Nycomed Investigational Site | Berlin | |
| Germany | Altana Pharma/Nycomed Investigational Site | Berlin | |
| Germany | Altana Pharma/Nycomed Investigational Site | Berlin | |
| Germany | Altana Pharma/Nycomed Investigational Site | Donaustauf | |
| Germany | Altana Pharma/Nycomed Investigational Site | Großhansdorf | |
| Germany | Altana Pharma/Nycomed Investigational Site | Halle | |
| Germany | Altana Pharma/Nycomed Investigational Site | Hamburg | |
| Germany | Altana Pharma/Nycomed Investigational Site | Landsberg/Lech | |
| Germany | Altana Pharma/Nycomed Investigational Site | Neuruppin | |
| Germany | Altana Pharma/Nycomed Investigational Site | Oschersleben | |
| Germany | Altana Pharma/Nycomed Investigational Site | Potsdam | |
| Germany | Altana Pharma/Nycomed Investigational Site | Potsdam | |
| Germany | Altana Pharma/Nycomed Investigational Site | Regensburg | |
| Germany | Altana Pharma/Nycomed Investigational Site | Rüdersdorf | |
| Germany | Altana Pharma/Nycomed Investigational Site | Ulm | |
| India | Altana Pharma/Nycomed Investigational Site | Bangalore | |
| India | Altana Pharma/Nycomed Investigational Site | Bangalore | |
| India | Altana Pharma/Nycomed Investigational Site | Bangalore, Karnataka | |
| India | Altana Pharma/Nycomed Investigational Site | Chennai | |
| India | Altana Pharma/Nycomed Investigational Site | Coimbatore | |
| India | Altana Pharma/Nycomed Investigational Site | Coimbatore | |
| India | Altana Pharma/Nycomed Investigational Site | Coimbatore, Tamilnadu | |
| India | Altana Pharma/Nycomed Investigational Site | Goa | |
| India | Altana Pharma/Nycomed Investigational Site | Hyderabad | |
| India | Altana Pharma/Nycomed Investigational Site | Indore, South Tukuganj | |
| India | Altana Pharma/Nycomed Investigational Site | Mangalore | |
| India | Altana Pharma/Nycomed Investigational Site | Mangalore | |
| India | Altana Pharma/Nycomed Investigational Site | Mumbai | |
| India | Altana Pharma/Nycomed Investigational Site | Mumbai, Byculla | |
| India | Altana Pharma/Nycomed Investigational Site | Mumbai, Dadar (E) | |
| India | Altana Pharma/Nycomed Investigational Site | Mysore | |
| India | Altana Pharma/Nycomed Investigational Site | Nagpur | |
| India | Altana Pharma/Nycomed Investigational Site | Nagpur | |
| India | Altana Pharma/Nycomed Investigational Site | Nagpur | |
| India | Altana Pharma/Nycomed Investigational Site | Pune | |
| India | Altana Pharma/Nycomed Investigational Site | Pune | |
| India | Altana Pharma/Nycomed Investigational Site | Shastri Nagar, Jaipur | |
| Italy | Altana Pharma/Nycomed Investigational Site | Bergamo | |
| Italy | Altana Pharma/Nycomed Investigational Site | Bologna | |
| Italy | Altana Pharma/Nycomed Investigational Site | Cassano Murge | |
| Italy | Altana Pharma/Nycomed Investigational Site | Firenze | |
| Italy | Altana Pharma/Nycomed Investigational Site | Milano | |
| Italy | Altana Pharma/Nycomed Investigational Site | Parma | |
| Italy | Altana Pharma/Nycomed Investigational Site | Pavia | |
| Italy | Altana Pharma/Nycomed Investigational Site | Roma | |
| Italy | Altana Pharma/Nycomed Investigational Site | Trieste | |
| Italy | Altana Pharma/Nycomed Investigational Site | Verona | |
| Italy | Altana Pharma/Nycomed Investigational Site | Veruno | |
| Poland | Altana Pharma/Nycomed Investigational Site | Chrzanów | |
| Poland | Altana Pharma/Nycomed Investigational Site | Czestochowa | |
| Poland | Altana Pharma/Nycomed Investigational Site | Dzialdowo | |
| Poland | Altana Pharma/Nycomed Investigational Site | Katowice | |
| Poland | Altana Pharma/Nycomed Investigational Site | Kraków | |
| Poland | Altana Pharma/Nycomed Investigational Site | Kraków | |
| Poland | Altana Pharma/Nycomed Investigational Site | Lublin | |
| Poland | Altana Pharma/Nycomed Investigational Site | Poznan | |
| Poland | Altana Pharma/Nycomed Investigational Site | Warsawa | |
| Poland | Altana Pharma/Nycomed Investigational Site | Warszawa | |
| Poland | Altana Pharma/Nycomed Investigational Site | Wodzislaw Slaski | |
| Poland | Altana Pharma/Nycomed Investigational Site | Zgierz | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Bellville, Cape Town | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Berea, Durban | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Bloemfontein | |
| South Africa | Altana Pharma/Nycomed Investigational Site | C/O Netcare & Garsfontein Roads | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Cape Town | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Cape Town | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Cape Town, Tygerberg | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Durban, Amanzimtoti | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Durbanville / Cape Town | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Mowbray, Cape Town | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Paarl, Cape Town | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Pretoria | |
| South Africa | Altana Pharma/Nycomed Investigational Site | Somerset West | |
| Spain | Altana Pharma/Nycomed Investigational Site | Badajoz | |
| Spain | Altana Pharma/Nycomed Investigational Site | Calde (Lugo) | |
| Spain | Altana Pharma/Nycomed Investigational Site | Cartagena | |
| Spain | Altana Pharma/Nycomed Investigational Site | Elda | |
| Spain | Altana Pharma/Nycomed Investigational Site | Getafe | |
| Spain | Altana Pharma/Nycomed Investigational Site | Guadalajara | |
| Spain | Altana Pharma/Nycomed Investigational Site | Madrid | |
| Spain | Altana Pharma/Nycomed Investigational Site | Madrid | |
| Spain | Altana Pharma/Nycomed Investigational Site | Merida (Badajoz) | |
| Spain | Altana Pharma/Nycomed Investigational Site | Partida de Bacarot (Alicante) | |
| Spain | Altana Pharma/Nycomed Investigational Site | Pontevedra | |
| Spain | Altana Pharma/Nycomed Investigational Site | Requena | |
| Spain | Altana Pharma/Nycomed Investigational Site | Santiago de Compostela | |
| Spain | Altana Pharma/Nycomed Investigational Site | Talavera de la Reina (Toledo) | |
| Spain | Altana Pharma/Nycomed Investigational Site | Tarrasa (Barcelona) | |
| Spain | Altana Pharma/Nycomed Investigational Site | Toldeo | |
| Spain | Altana Pharma/Nycomed Investigational Site | Valencia | |
| Spain | Altana Pharma/Nycomed Investigational Site | Valencia | |
| United States | Altana Pharma/Nycomed Investigational Site | Absecon | New Jersey |
| United States | Altana Pharma/Nycomed Investigational Site | Anaheim | California |
| United States | Altana Pharma/Nycomed Investigational Site | Atlanta | Georgia |
| United States | Altana Pharma/Nycomed Investigational Site | Bayou La Batre | Alabama |
| United States | Altana Pharma/Nycomed Investigational Site | Birmingham | Alabama |
| United States | Altana Pharma/Nycomed Investigational Site | Birmingham | Alabama |
| United States | Altana Pharma/Nycomed Investigational Site | Blue Ridge | Georgia |
| United States | Altana Pharma/Nycomed Investigational Site | Boerne | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | Boston | Massachusetts |
| United States | Altana Pharma/Nycomed Investigational Site | Bozeman | Montana |
| United States | Altana Pharma/Nycomed Investigational Site | Brighton | Michigan |
| United States | Altana Pharma/Nycomed Investigational Site | Bullhead City | Arizona |
| United States | Altana Pharma/Nycomed Investigational Site | Burbank | California |
| United States | Altana Pharma/Nycomed Investigational Site | Butte | Montana |
| United States | Altana Pharma/Nycomed Investigational Site | Camillus | New York |
| United States | Altana Pharma/Nycomed Investigational Site | Campbellsville | Kentucky |
| United States | Altana Pharma/Nycomed Investigational Site | Canton | Ohio |
| United States | Altana Pharma/Nycomed Investigational Site | Carlsbad | California |
| United States | Altana Pharma/Nycomed Investigational Site | Champaign | Illinois |
| United States | Altana Pharma/Nycomed Investigational Site | Charleston | South Carolina |
| United States | Altana Pharma/Nycomed Investigational Site | Charleston | West Virginia |
| United States | Altana Pharma/Nycomed Investigational Site | Charlotte | North Carolina |
| United States | Altana Pharma/Nycomed Investigational Site | Chesterfield | Missouri |
| United States | Altana Pharma/Nycomed Investigational Site | Chicago | Illinois |
| United States | Altana Pharma/Nycomed Investigational Site | Cincinnati | Ohio |
| United States | Altana Pharma/Nycomed Investigational Site | Clearwater | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Columbia | Maryland |
| United States | Altana Pharma/Nycomed Investigational Site | Columbus | Georgia |
| United States | Altana Pharma/Nycomed Investigational Site | Columbus | Ohio |
| United States | Altana Pharma/Nycomed Investigational Site | Corning | New York |
| United States | Altana Pharma/Nycomed Investigational Site | Corsicana | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | Cortland | New York |
| United States | Altana Pharma/Nycomed Investigational Site | Decatur | Georgia |
| United States | Altana Pharma/Nycomed Investigational Site | Deland | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Denver | Colorado |
| United States | Altana Pharma/Nycomed Investigational Site | Dubuque | Iowa |
| United States | Altana Pharma/Nycomed Investigational Site | Duluth | Minnesota |
| United States | Altana Pharma/Nycomed Investigational Site | Edina | Minnesota |
| United States | Altana Pharma/Nycomed Investigational Site | Elk Grove Village | Illinois |
| United States | Altana Pharma/Nycomed Investigational Site | Elkhart | Indiana |
| United States | Altana Pharma/Nycomed Investigational Site | Erie | Pennsylvania |
| United States | Altana Pharma/Nycomed Investigational Site | Fort Dodge | Iowa |
| United States | Altana Pharma/Nycomed Investigational Site | Fort Lauderdale | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Fort Smith | Arkansas |
| United States | Altana Pharma/Nycomed Investigational Site | Fort Worth | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | Fresno | California |
| United States | Altana Pharma/Nycomed Investigational Site | Ft. Gordon | Georgia |
| United States | Altana Pharma/Nycomed Investigational Site | Glendale | Wisconsin |
| United States | Altana Pharma/Nycomed Investigational Site | Glendale | Wisconsin |
| United States | Altana Pharma/Nycomed Investigational Site | Greenville | South Carolina |
| United States | Altana Pharma/Nycomed Investigational Site | Greenville | South Carolina |
| United States | Altana Pharma/Nycomed Investigational Site | Greer | South Carolina |
| United States | Altana Pharma/Nycomed Investigational Site | Hamilton | New Jersey |
| United States | Altana Pharma/Nycomed Investigational Site | Hazard | Kentucky |
| United States | Altana Pharma/Nycomed Investigational Site | Hershey | Pennsylvania |
| United States | Altana Pharma/Nycomed Investigational Site | Houston | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | Houston | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | Huntersville | North Carolina |
| United States | Altana Pharma/Nycomed Investigational Site | Huntsville | Alabama |
| United States | Altana Pharma/Nycomed Investigational Site | Hurst | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | Indianapolis | Indiana |
| United States | Altana Pharma/Nycomed Investigational Site | Indianapolis | Indiana |
| United States | Altana Pharma/Nycomed Investigational Site | Interlochen | Michigan |
| United States | Altana Pharma/Nycomed Investigational Site | Iowa City | Iowa |
| United States | Altana Pharma/Nycomed Investigational Site | Jacksonville | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Jefferson City | Missouri |
| United States | Altana Pharma/Nycomed Investigational Site | Johnson City | Tennessee |
| United States | Altana Pharma/Nycomed Investigational Site | Johnston | Rhode Island |
| United States | Altana Pharma/Nycomed Investigational Site | Kansas City | Missouri |
| United States | Altana Pharma/Nycomed Investigational Site | Kansas City (-1453) | Missouri |
| United States | Altana Pharma/Nycomed Investigational Site | Knoxville | Tennessee |
| United States | Altana Pharma/Nycomed Investigational Site | Lakewood | California |
| United States | Altana Pharma/Nycomed Investigational Site | Las Vegas | Nevada |
| United States | Altana Pharma/Nycomed Investigational Site | Las Vegas | Nevada |
| United States | Altana Pharma/Nycomed Investigational Site | Little Rock | Arkansas |
| United States | Altana Pharma/Nycomed Investigational Site | Livonia | Michigan |
| United States | Altana Pharma/Nycomed Investigational Site | Long Beach | California |
| United States | Altana Pharma/Nycomed Investigational Site | Los Alamitos | California |
| United States | Altana Pharma/Nycomed Investigational Site | Los Angeles | California |
| United States | Altana Pharma/Nycomed Investigational Site | Louisville | Kentucky |
| United States | Altana Pharma/Nycomed Investigational Site | Lynchburg | Virginia |
| United States | Altana Pharma/Nycomed Investigational Site | Marietta | Georgia |
| United States | Altana Pharma/Nycomed Investigational Site | McKinney | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | Medford | Oregon |
| United States | Altana Pharma/Nycomed Investigational Site | Memphis | Tennessee |
| United States | Altana Pharma/Nycomed Investigational Site | Metairie | Louisiana |
| United States | Altana Pharma/Nycomed Investigational Site | Miami | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Miami | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Miami Beach | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Minneapolis | Minnesota |
| United States | Altana Pharma/Nycomed Investigational Site | Nashville | Tennessee |
| United States | Altana Pharma/Nycomed Investigational Site | New Albany | Indiana |
| United States | Altana Pharma/Nycomed Investigational Site | New Hyde Park | New York |
| United States | Altana Pharma/Nycomed Investigational Site | New Hyde Park | New York |
| United States | Altana Pharma/Nycomed Investigational Site | New Tazewell | Tennessee |
| United States | Altana Pharma/Nycomed Investigational Site | North Chicago | Illinois |
| United States | Altana Pharma/Nycomed Investigational Site | Ocala | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Oklahoma City | Oklahoma |
| United States | Altana Pharma/Nycomed Investigational Site | Olathe | Kansas |
| United States | Altana Pharma/Nycomed Investigational Site | Omaha | Nebraska |
| United States | Altana Pharma/Nycomed Investigational Site | Ormand Beach | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Peoria | Illinois |
| United States | Altana Pharma/Nycomed Investigational Site | Philadelphia | Pennsylvania |
| United States | Altana Pharma/Nycomed Investigational Site | Philadelphia | Pennsylvania |
| United States | Altana Pharma/Nycomed Investigational Site | Phoenix | Arizona |
| United States | Altana Pharma/Nycomed Investigational Site | Phoenix | Arizona |
| United States | Altana Pharma/Nycomed Investigational Site | Pittsburgh | Pennsylvania |
| United States | Altana Pharma/Nycomed Investigational Site | Port Orange | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Portage | Michigan |
| United States | Altana Pharma/Nycomed Investigational Site | Portland | Oregon |
| United States | Altana Pharma/Nycomed Investigational Site | Rincon | Georgia |
| United States | Altana Pharma/Nycomed Investigational Site | River Forest | Illinois |
| United States | Altana Pharma/Nycomed Investigational Site | Rochester | Minnesota |
| United States | Altana Pharma/Nycomed Investigational Site | Roseville | California |
| United States | Altana Pharma/Nycomed Investigational Site | Sacramento | California |
| United States | Altana Pharma/Nycomed Investigational Site | Saginaw | Michigan |
| United States | Altana Pharma/Nycomed Investigational Site | Salt Lake City | Utah |
| United States | Altana Pharma/Nycomed Investigational Site | Salt Lake City | Utah |
| United States | Altana Pharma/Nycomed Investigational Site | San Antonio | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | San Antonio | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | San Diego | California |
| United States | Altana Pharma/Nycomed Investigational Site | San Diego | California |
| United States | Altana Pharma/Nycomed Investigational Site | Savannah | Georgia |
| United States | Altana Pharma/Nycomed Investigational Site | Seattle | Washington |
| United States | Altana Pharma/Nycomed Investigational Site | Seguin | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | Sepulveda | California |
| United States | Altana Pharma/Nycomed Investigational Site | South Bound Brook | New Jersey |
| United States | Altana Pharma/Nycomed Investigational Site | Spokane | Washington |
| United States | Altana Pharma/Nycomed Investigational Site | St. Louis | Missouri |
| United States | Altana Pharma/Nycomed Investigational Site | St. Louis | Missouri |
| United States | Altana Pharma/Nycomed Investigational Site | Stockton | California |
| United States | Altana Pharma/Nycomed Investigational Site | Stoneboro | Pennsylvania |
| United States | Altana Pharma/Nycomed Investigational Site | Sunset | Missouri |
| United States | Altana Pharma/Nycomed Investigational Site | Swarthmore | Pennsylvania |
| United States | Altana Pharma/Nycomed Investigational Site | Sylvania | Ohio |
| United States | Altana Pharma/Nycomed Investigational Site | Syracuse | New York |
| United States | Altana Pharma/Nycomed Investigational Site | Tamarac | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Toledo | Ohio |
| United States | Altana Pharma/Nycomed Investigational Site | Toledo | Ohio |
| United States | Altana Pharma/Nycomed Investigational Site | Toledo | Ohio |
| United States | Altana Pharma/Nycomed Investigational Site | Topeka | Kansas |
| United States | Altana Pharma/Nycomed Investigational Site | Twin Falls | Idaho |
| United States | Altana Pharma/Nycomed Investigational Site | Tyler | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | Union | South Carolina |
| United States | Altana Pharma/Nycomed Investigational Site | Vero Beach | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Washington | District of Columbia |
| United States | Altana Pharma/Nycomed Investigational Site | Waterbury | Connecticut |
| United States | Altana Pharma/Nycomed Investigational Site | Waterloo | Iowa |
| United States | Altana Pharma/Nycomed Investigational Site | West Monroe | Louisiana |
| United States | Altana Pharma/Nycomed Investigational Site | Williamston | South Carolina |
| United States | Altana Pharma/Nycomed Investigational Site | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
United States, Canada, Germany, India, Italy, Poland, South Africa, Spain,
Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) | Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L] | Change from baseline over 52 weeks of treatment | No |
| Primary | COPD Exacerbation Rate (Moderate or Severe) | Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005]. |
52 weeks treatment period | No |
| Secondary | Post-bronchodilator FEV1 [L] | Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L] | Change from baseline over 52 weeks of treatment | No |
| Secondary | Time to Mortality Due to Any Reason | 52 weeks treatment period | No | |
| Secondary | Natural Log-transformed C-reactive Protein (CRP) | Mean change from baseline to the last post randomization measurement in natural log-transformed CRP | Change from baseline to last post randomization measurement (52 weeks) | No |
| Secondary | Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period | The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: Functional Impairment Magnitude of Task Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in Functional Impairment Magnitude of Task Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9. |
Change from baseline over 52 weeks of treatment | No |
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