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Search / Trial NCT00424268

Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

Launched by ASTRAZENECA · Jan 18, 2007

Trial Information

Current as of May 08, 2025

Completed

Keywords

Copd Roflumilast

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Main Inclusion Criteria:
  • History of COPD for at least 12 months prior to baseline visit and chronic productive cough for 3 months in each of the 2 years prior to baseline visit
  • FEV1/FVC ratio (post-bronchodilator) ≤ 70%
  • FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
  • Treated with tiotropium for at least 3 months before enrollment
  • At least 28 puffs of rescue medication during last week prior to randomization
  • Main Exclusion Criteria:
  • COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit

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

Feldbach, , Austria

Gänserndorf, , Austria

Hallein, , Austria

Linz, , Austria

Spittal An Der Drau, , Austria

Beuvry, , France

Chauny Cedex, , France

Grasse, , France

Lyon, , France

Martigues Cedex, , France

Nice, , France

Nimes, , France

Ollioules, , France

Perpignan Cedex, , France

Saint Laurent Du Var, , France

Saint Quentin, , France

Toulon, , France

Marburg, , Germany

Schwetzingen, , Germany

Nyiregyháza, , Hungary

Chesterfield, , United Kingdom

Co. Antrim, , United Kingdom

East Sussex, , United Kingdom

Glasgow, , United Kingdom

Harrow, , United Kingdom

Sheffield, , United Kingdom

Solihull, , United Kingdom

Landsberg/Lech, , Germany

Guadalajara, , Spain

Requena, , Spain

Nantes, , France

Geesthacht, , Germany

Gelnhausen, , Germany

Hannover, , Germany

Koblenz, , Germany

Sinsheim, , Germany

Witten, , Germany

Cisanello (Pi), , Italy

Milano, , Italy

Pordenone, , Italy

Verona, , Italy

Bexhill On Sea, East Sussex, , United Kingdom

Chesterfield Derbyshire, , United Kingdom

Watford, , United Kingdom

Montigny Les Metz, , France

Nimes Cedex 9, , France

Bad Homburg, , Germany

Dortmund, , Germany

Göppingen, , Germany

Leonberg, , Germany

Saarbrücken, , Germany

Saarlouis, , Germany

Weyhe, , Germany

Budapest, , Hungary

Cegled, , Hungary

Csorna, , Hungary

Erd, , Hungary

Györ, , Hungary

Hódmezovásárhely, , Hungary

Matrahaza, , Hungary

Szentes, , Hungary

Szolnok, , Hungary

Bassano Del Grappa (Vi), , Italy

Foggia, , Italy

Genova, , Italy

Modena, , Italy

Pavullo Nel Frignano (Mo), , Italy

Reggio Emilia, , Italy

Alicante, , Spain

Baracaldo (Vizcaya), , Spain

Candia, , Spain

Escaldes Engordany, , Spain

Galdakao, , Spain

Jerez De La Frontera, , Spain

La Coruna, , Spain

Lleida, , Spain

Lugo, , Spain

Madrid, , Spain

Mostoles Madrid, , Spain

Pozuelo De Alarcón, , Spain

Sant Cugat Del Valles, , Spain

Santa Cruz De Tenerife, , Spain

Sevilla, , Spain

Valencia, , Spain

Ashford, , United Kingdom

Atherstone, Warwick, , United Kingdom

Barry, , United Kingdom

Bolton Lancs, , United Kingdom

Bolton, , United Kingdom

Chippenham, , United Kingdom

Darlington, Co. Durham, , United Kingdom

Keresely End, Coventry, , United Kingdom

Plymouth, , United Kingdom

Swindon, Wilts, , United Kingdom

Trowbridge, , United Kingdom

Yaxley, , 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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