Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
Launched by ASTRAZENECA · Sep 28, 2011
Trial Information
Current as of May 22, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Male or female patients at least 40 years of age
- • 2. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
- • 3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) \< 70% at Screening (Visit 1)
- • 4. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
- • 5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
- • 6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
- • 7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years
- Exclusion Criteria:
- • 1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
- • 2. Known alpha-1-antitrypsin deficiency
- • 3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
- • 4. Body mass index (BMI) ≥ 45 kg/m2
- • 5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kissimmee, Florida, United States
Anniston, Alabama, United States
Athens, Alabama, United States
Florence, Alabama, United States
Mobile, Alabama, United States
Mesa, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Fort Smith, Arkansas, United States
Little Rock, Arkansas, United States
Bellflower, California, United States
Fresno, California, United States
Fresno, California, United States
Fullerton, California, United States
Garden Grove, California, United States
Lakewood, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Palo Alto, California, United States
Pismo Beach, California, United States
Riverside, California, United States
Roseville, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Jose, California, United States
Torrance, California, United States
Stamford, Connecticut, United States
Waterbury, Connecticut, United States
Newark, Delaware, United States
Brandon, Florida, United States
Brandon, Florida, United States
Brandon, Florida, United States
Chiefland, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Defuniak Springs, Florida, United States
Fort Lauderdale, Florida, United States
Fort Walton Beach, Florida, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Pensacola, Florida, United States
Ponte Vedra, Florida, United States
Port Orange, Florida, United States
Saint Petersburg, Florida, United States
St. Cloud, Florida, United States
St. Petersburg, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Winter Park, Florida, United States
Canton, Georgia, United States
Dawsonville, Georgia, United States
Duluth, Georgia, United States
Gainesville, Georgia, United States
Lawrenceville, Georgia, United States
Woodstock, Georgia, United States
Coeur D' Alene, Idaho, United States
Eagle, Idaho, United States
Bolingbrook, Illinois, United States
Downers Grove, Illinois, United States
Elk Grove Village, Illinois, United States
Oak Lawn, Illinois, United States
Peoria, Illinois, United States
Springfield, Illinois, United States
Elwood, Indiana, United States
Lafayette, Indiana, United States
Michigan City, Indiana, United States
Muncie, Indiana, United States
Council Bluffs, Iowa, United States
Iowa City, Iowa, United States
Olathe, Kansas, United States
Topeka, Kansas, United States
Wichita, Kansas, United States
Bowling Green, Kentucky, United States
Crescent Springs, Kentucky, United States
Hazard, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Lafayette, Louisiana, United States
Opelousas, Louisiana, United States
Sunset, Louisiana, United States
Lewiston, Maine, United States
Baltimore, Maryland, United States
Columbia, Maryland, United States
Towson, Maryland, United States
Fall River, Massachusetts, United States
North Dartmouth, Massachusetts, United States
Pittsfield, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Livonia, Michigan, United States
Saint Joseph, Michigan, United States
Edina, Minnesota, United States
Fridley, Minnesota, United States
Rochester, Minnesota, United States
Chesterfield, Missouri, United States
Springfield, Missouri, United States
St. Charles, Missouri, United States
St. Louis, Missouri, United States
St. Louis, Missouri, United States
Butte, Montana, United States
Missoula, Montana, United States
Bellevue, Nebraska, United States
Fremont, Nebraska, United States
Fremont, Nebraska, United States
Lincoln, Nebraska, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Cherry Hill, New Jersey, United States
Clifton, New Jersey, United States
Hackensack, New Jersey, United States
Summit, New Jersey, United States
Brooklyn, New York, United States
Great Neck, New York, United States
New York, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
West Seneca, New York, United States
Asheville, North Carolina, United States
Burlington, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Elizabeth City, North Carolina, United States
Shelby, North Carolina, United States
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Wilmington, North Carolina, United States
Winston Salem, North Carolina, United States
Winston Salem, North Carolina, United States
Canton, Ohio, United States
Cincinatti, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Marion, Ohio, United States
Marion, Ohio, United States
Toledo, Ohio, United States
Zanesville, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Altoona, Pennsylvania, United States
Beaver, Pennsylvania, United States
Downingtown, Pennsylvania, United States
Erie, Pennsylvania, United States
Norristown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Tipton, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Johnston, Rhode Island, United States
Lincoln, Rhode Island, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Easley, South Carolina, United States
Fort Mill, South Carolina, United States
Gaffney, South Carolina, United States
Greenville, South Carolina, United States
Pelzer, South Carolina, United States
Rock Hill, South Carolina, United States
Spartanburg, South Carolina, United States
Union, South Carolina, United States
Rapid City, South Dakota, United States
Bristol, Tennessee, United States
Fayetteville, Tennessee, United States
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Arlington, Texas, United States
Boerne, Texas, United States
Corsicana, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Huntsville, Texas, United States
Longview, Texas, United States
Tyler, Texas, United States
Colchester, Vermont, United States
Abingdon, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Charleston, West Virginia, United States
Morgantown, West Virginia, United States
West Allis, Wisconsin, United States
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Florida, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Mar Del Plata, Buenos Aires, Argentina
Parana, Entre Rios, Argentina
Lanús Este, Provincia De Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Derqui Pilar Buenos Aires, , Argentina
Florencio Varela, , Argentina
La Plata, , Argentina
Mendoza, , Argentina
Mendoza, , Argentina
San Miguel De Tucuman, , Argentina
Santa Fe, , Argentina
Calgary, Alberta, Canada
North Vancouver, British Columbia, Canada
Burlington, Ontario, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Talcahuano, , Chile
Bogota, , Colombia
Bogota, , Colombia
Chieti, , Italy
Roma, , Italy
Batu Caves, , Malaysia
Kuala Lumpur, , Malaysia
Kuala Lumpur, , Malaysia
Kuantan, , Malaysia
Monterrey, Nuevo León, Mexico
Merida, Yucatan, Mexico
Guadalajara, , Mexico
Monterrey, , Mexico
Bellavista, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Pueblo Libre, , Peru
Cavite, , Philippines
Iloilo City, , Philippines
Iloilo City, , Philippines
Manila, , Philippines
Pasig City, , Philippines
Quezon City, , Philippines
Quezon City, , Philippines
Quezon City, , Philippines
Quezon City, , Philippines
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Iasi, , Romania
Iasi, , Romania
Barnaul, , Russian Federation
Kazan, , Russian Federation
Kemerovo, , Russian Federation
Krasnodar, , Russian Federation
Krasnoyarsk, , Russian Federation
Moscow, , Russian Federation
Novosibirsk, , Russian Federation
St Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
St.Petersburg, , Russian Federation
Tomsk, , Russian Federation
Yaroslavl, , Russian Federation
Knez Selo, Nišava District, Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Beograd, , Serbia
Kragujevac, , Serbia
Sremska Kamenica, , Serbia
Cadiz, , Spain
Loja, , Spain
Salt, , Spain
Kaohsiung Hsien, , Taiwan
Puzih City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Hat Yai, Songkhla, Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Muang, , Thailand
Cherkasy, , Ukraine
Dnipropetrovsk, , Ukraine
Donetsk, , Ukraine
Donetsk, , Ukraine
Ivano Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kremenchuk, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Mykolayiv, , Ukraine
Poltava, , Ukraine
Sumy, , Ukraine
Vinnitsa, , Ukraine
Zaporizhzhia, , Ukraine
Zaporizhzhya, , Ukraine
Zaporizhzhya, , Ukraine
Zaporizhzhya, , Ukraine
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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