Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Combinations of Long-acting β2-agonists (LABA) and Inhaled Glucocorticosteroid (ICS)
Launched by ASTRAZENECA · Apr 4, 2011
Trial Information
Current as of May 22, 2025
Completed
Keywords
ClinConnect Summary
The drug tested in this study is called Roflumilast. Roflumilast is being developed to treat people who have chronic obstructive pulmonary disease (COPD). This study investigated the effect of roflumilast 500 μg tablets once daily versus placebo on exacerbation rate, pulmonary function, and major adverse cardiovascular events (MACE) in COPD patients who were concomitantly treated with a fixed combination of long-acting beta-agonists (LABA) and inhaled glucocorticosteroids.
The study was targeted to enroll approximately 1934 patients. Participants were randomly assigned (by chance, like fli...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Giving written informed consent
- • History of COPD (according to GOLD 2009) for at least 12 months prior to baseline Visit V0 associated with chronic productive cough for 3 months in each of the 2 years prior to baseline visit (with other causes of productive cough excluded)
- • Age ≥ 40 years
- • Forced expiratory volume after one second (FEV1)/forced vital capacity (FVC) ratio (post-bronchodilator) \< 70%
- • FEV1 (post-bronchodilator) ≤ 50% of predicted
- • At least two documented moderate or severe COPD exacerbations within one year prior to baseline visit
- • Patients must be pre-treated with LABA and ICS for at least 12 months before baseline Visit V0. Up to 3 months before baseline Visit V0 free or fixed combinations of LABA and ICS are allowed, including changes in dose, active substances, and brands. In the last 3 months before baseline Visit V0 patients must be pre-treated with fixed combinations of LABA and ICS at a constant dose (maximum approved dosage strength of the combination).
- • Former smoker (defined as smoking cessation at least one year ago) or current smoker both with a smoking history of at least 20 pack years
- Main Exclusion Criteria:
- • Exacerbations not resolved at first baseline visit
- • Diagnosis of asthma and/or other relevant lung disease
- • Known alpha-1-antitrypsin deficiency
- • Other protocol-defined exclusion criteria may apply
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
Box Hill, , Australia
Clayton, , Australia
Concord, , Australia
Daws Park, , Australia
Frankston, , Australia
Heidelberg, , Australia
Parkville, , Australia
Toorak Gardens, , Australia
Feldbach, , Austria
Graz, , Austria
Salzburg, , Austria
Wien, , Austria
Bruxelles, , Belgium
Halen, , Belgium
Liege, , Belgium
Malmedy, , Belgium
Belo Horizonte, , Brazil
Botucatu, , Brazil
Florianópolis, , Brazil
Goiânia, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Sao Paolo, , Brazil
Vitória, , Brazil
Hamilton, , Canada
Kingston, , Canada
Lachine, , Canada
Niagara Falls, , Canada
Richmond Hill, , Canada
Toronto, , Canada
Winnepeg, , Canada
Hellerup, , Denmark
Hillerød, , Denmark
Hvidovre, , Denmark
København Nv, , Denmark
Férolles Attilly, , France
Nîmes, , France
Poitiers, , France
Saint Laurent Du Var, , France
Strasbourg, , France
Berlin, , Germany
Fürth, , Germany
Großhansdorf, , Germany
Hannover, , Germany
Homburg, , Germany
Koblenz, , Germany
Marburg, , Germany
Rüdersdorf, , Germany
Alexandroupolis, , Greece
Athens, , Greece
Heraklion, Crete, , Greece
Kavala, , Greece
Larissa, , Greece
Marousi, , Greece
Thessaloniki, , Greece
Balassagyarmat, , Hungary
Budapest, , Hungary
Cegléd, , Hungary
Csorna, , Hungary
Deszk, , Hungary
Erd, , Hungary
Miskolc, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Siófok, , Hungary
Sopron, , Hungary
Szombathely, , Hungary
Törökbálint, , Hungary
Ashkelon, , Israel
Beer Sheva, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Jerusalm, , Israel
Kfar Saba, , Israel
Petach Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Tel Hashomer, , Israel
Tel Aviv, , Israel
Ferrara, , Italy
Genova, , Italy
Milano, , Italy
Modena, , Italy
Monza, , Italy
Pordenone, , Italy
Roma, , Italy
Anyang, , Korea, Republic Of
Cheongju, , Korea, Republic Of
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Wonju, , Korea, Republic Of
'S Hertogenbosch, , Netherlands
Amersfoort, , Netherlands
Arnhem, , Netherlands
Enschede, , Netherlands
Heerlen, , Netherlands
Hoorn, , Netherlands
Bialystok, , Poland
Bydgoszcz, , Poland
Gliwice, , Poland
Katowice, , Poland
Lodz, , Poland
Lublin, , Poland
Olesnica, , Poland
Ostrow Wielkopolski, , Poland
Tarnow, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Zawadzkie, , Poland
Chelyabinsk, , Russian Federation
Kazan, , Russian Federation
Kemerovo, , Russian Federation
Moscow, , Russian Federation
Nizhniy Novgorod, , Russian Federation
Novosibirsk, , Russian Federation
Samara, , Russian Federation
Saratov, , Russian Federation
Smolensk, , Russian Federation
St Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
Volgograd, , Russian Federation
Vsevolozhsk, , Russian Federation
Yaroslavl, , Russian Federation
Banska Bystrica, , Slovakia
Bardejov, , Slovakia
Bratislava, , Slovakia
Kosice, , Slovakia
Martin, , Slovakia
Nitra, , Slovakia
Nove Zamky, , Slovakia
Spisska Nova Ves, , Slovakia
Auckland Park, Johannesburg Gauteng, , South Africa
Benoni Gauteng, , South Africa
Bloemfontein Free State, , South Africa
Cape Town Western Cape, , South Africa
Durban Kwazulu Natal, , South Africa
Johannesburg, , South Africa
Morningside, Johannesburg Gauteng, , South Africa
Thabazimbi Limpopo, , South Africa
Umkomaas Kwazulu Natal, , South Africa
Witbank Mpumalanga, , South Africa
Barcelona, , Spain
Guadalajara, , Spain
Madrid, , Spain
Pozuelo De Alarcon, , Spain
Santander, , Spain
Terrassa, , Spain
Valencia, , Spain
Ankara, , Turkey
Canakkale, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Kocaeli, , Turkey
Konya, , Turkey
Mersin, , Turkey
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Norwich, , United Kingdom
Patients applied
Trial Officials
AstraZeneca AstraZeneca
Study Director
AstraZeneca
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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