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Search / Trial NCT01329029

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 01, 2025

Completed

Keywords

Copd Roflumilast Daxas

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.

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

0 patients applied

Trial Officials

AstraZeneca AstraZeneca

Study Director

AstraZeneca

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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