Clinical trial NCT00297115: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)
Official title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Roflumilast
COPD
Chronic obstructive pulmonary disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-02-28
Enrollment: 1568
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
timeFrame: Change from baseline over 52 weeks of treatment
measure: COPD Exacerbation Rate (Moderate or Severe)
timeFrame: 52 weeks treatment period
Secondary outcomes:
measure: Post-bronchodilator FEV1 [L]
timeFrame: Change from baseline over 52 weeks of treatment
measure: Time to Mortality Due to Any Reason
timeFrame: 52 weeks treatment period
measure: Natural Log-transformed C-reactive Protein (CRP)
timeFrame: Change from baseline to last post randomization measurement (52 weeks)
measure: Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
timeFrame: Change from baseline over 52 weeks of treatment
Other outcomes:
Locations:
city: Bayou La Batre
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Alabama
city: Bullhead City
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Arizona
city: Fort Smith
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Burbank
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Carlsbad
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Fresno
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Lakewood
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Long Beach
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Los Alamitos
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Los Angeles
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Roseville
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Sacramento
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: San Diego
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: San Diego
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Sepulveda
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Stockton
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Denver
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: District of Columbia
city: Clearwater
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Deland
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Miami
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Miami
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Ocala
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Ormand Beach
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Tamarac
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Georgia
city: Blue Ridge
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Georgia
city: Columbus
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Georgia
city: Ft. Gordon
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Georgia
city: Rincon
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Georgia
city: Twin Falls
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Idaho
city: Champaign
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Illinois
city: Elk Grove Village
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Illinois
city: North Chicago
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Illinois
city: River Forest
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Illinois
city: Elkhart
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Indiana
city: New Albany
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Indiana
city: Dubuque
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Iowa
city: Fort Dodge
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Iowa
city: Iowa City
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Iowa
city: Waterloo
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Iowa
city: Olathe
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Kansas
city: Topeka
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Kansas
city: Campbellsville
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Kentucky
city: Hazard
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Louisiana
city: West Monroe
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Louisiana
city: Columbia
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Maryland
city: Boston
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Massachusetts
city: Brighton
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Michigan
city: Interlochen
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Michigan
city: Livonia
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Michigan
city: Portage
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Michigan
city: Saginaw
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Michigan
city: Duluth
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Minnesota
city: Edina
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Minnesota
city: Chesterfield
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Missouri
city: Jefferson City
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Missouri
city: Kansas City (-1453)
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Missouri
city: Sunset
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Missouri
city: Bozeman
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Montana
city: Butte
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Montana
city: Omaha
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Nevada
city: Absecon
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: New Jersey
city: Hamilton
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: New Jersey
city: South Bound Brook
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: New Jersey
city: Camillus
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: New York
city: Corning
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: New York
city: Cortland
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: New York
city: New Hyde Park
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: New York
city: New Hyde Park
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: New York
city: Syracuse
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: New York
city: Charlotte
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: North Carolina
city: Canton
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Ohio
city: Sylvania
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Oregon
city: Portland
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Oregon
city: Erie
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Pennsylvania
city: Stoneboro
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Pennsylvania
city: Swarthmore
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Pennsylvania
city: Johnston
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: South Carolina
city: Union
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: South Carolina
city: Williamston
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: South Carolina
city: Johnson City
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Tennessee
city: New Tazewell
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Tennessee
city: Boerne
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: Corsicana
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: Houston
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: Houston
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: Hurst
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: McKinney
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: Seguin
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: Tyler
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Utah
city: Lynchburg
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Washington
city: Spokane
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Washington
city: Charleston
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: West Virginia
city: Glendale
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Wisconsin
city: Glendale
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Wisconsin
city: Calgary
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Alberta
city: Spruce Grove
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Alberta
city: Burnaby
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: British Columbia
city: Penticton
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: British Columbia
city: Truro
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Nova Scotia
city: Chatham
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Ontario
city: London
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Quebec
city: St. Romuald
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
state: Quebec
city: Antigonish
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Bridgewater
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Calgary
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Corunna
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Edmonton
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Fort Erie
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Grimsby
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Hamilton
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Longueuil
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Montreal
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Ontario
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Richmond Hill
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Saint John
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Sherbrooke
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: St Jerome
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: St Leonard
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Toronto
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Winnipeg
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Donaustauf
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Großhansdorf
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Halle
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Hamburg
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Landsberg/Lech
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Neuruppin
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Oschersleben
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Potsdam
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Potsdam
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Regensburg
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Rüdersdorf
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Ulm
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Bangalore, Karnataka
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Bangalore
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Bangalore
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Chennai
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Coimbatore, Tamilnadu
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Coimbatore
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Coimbatore
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Goa
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Hyderabad
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Indore, South Tukuganj
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Mangalore
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Mangalore
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Mumbai, Byculla
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Mumbai, Dadar (E)
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Mumbai
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Mysore
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Nagpur
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Nagpur
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Nagpur
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Pune
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Pune
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Shastri Nagar, Jaipur
country: India
facility: Altana Pharma/Nycomed Investigational Site
city: Bergamo
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Bologna
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Cassano Murge
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Firenze
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Milano
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Parma
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Pavia
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Roma
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Trieste
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Verona
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Veruno
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Chrzanów
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Czestochowa
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Dzialdowo
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Katowice
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Kraków
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Kraków
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Lublin
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Poznan
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Warsawa
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Warszawa
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Wodzislaw Slaski
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Zgierz
country: Poland
facility: Altana Pharma/Nycomed Investigational Site
city: Bellville, Cape Town
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Berea, Durban
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Bloemfontein
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: C/O Netcare & Garsfontein Roads
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Cape Town, Tygerberg
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Cape Town
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Cape Town
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Durban, Amanzimtoti
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Durbanville / Cape Town
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Mowbray, Cape Town
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Paarl, Cape Town
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Pretoria
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Somerset West
country: South Africa
facility: Altana Pharma/Nycomed Investigational Site
city: Badajoz
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Calde (Lugo)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Cartagena
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Elda
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Getafe
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Guadalajara
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Merida (Badajoz)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Partida de Bacarot (Alicante)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Pontevedra
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Requena
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Santiago de Compostela
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Talavera de la Reina (Toledo)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Tarrasa (Barcelona)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Toldeo
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Valencia
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Valencia
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
citation: 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/S0140-6736(09)61255-1.
citation: Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
citation: Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.
citation: Wedzicha JA, Rabe KF, Martinez FJ, Bredenbroker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489.
citation: Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.