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 29, 2025
Completed
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Trial Officials
AstraZeneca AstraZeneca
Study Director
AstraZeneca
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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