Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)
NCT ID: NCT00424268
Last Updated: 2016-12-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
743 participants
INTERVENTIONAL
2007-01-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Roflumilast
Roflumilast 500 µg
underlying medication: tiotropium 18 µg, once daily, inhaled
Roflumilast
500 µg, once daily, oral administration in the morning
Placebo
Placebo
underlying medication: tiotropium 18 µg, once daily, inhaled
Placebo
once daily
Interventions
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Roflumilast
500 µg, once daily, oral administration in the morning
Placebo
once daily
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Altana Pharma/Nycomed Investigational Site
Feldbach, , Austria
Altana Pharma/Nycomed Investigational Site
Gänserndorf, , Austria
Altana Pharma/Nycomed Investigational Site
Hallein, , Austria
Altana Pharma/Nycomed Investigational Site
Linz, , Austria
Altana Pharma/Nycomed Investigational Site
Spittal an der Drau, , Austria
Altana Pharma/Nycomed Investigational Site
Beuvry, , France
Altana Pharma/Nycomed Investigational Site
Chauny, , France
Altana Pharma/Nycomed Investigational Site
Grasse, , France
Altana Pharma/Nycomed Investigational Site
Lyon, , France
Altana Pharma/Nycomed Investigational Site
Martigues, , France
Altana Pharma/Nycomed Investigational Site
Montigny-lès-Metz, , France
Altana Pharma/Nycomed Investigational Site
Nantes, , France
Altana Pharma/Nycomed Investigational Site
Nice, , France
Altana Pharma/Nycomed Investigational Site
Nîmes, , France
Altana Pharma/Nycomed Investigational Site
Nîmes, , France
Altana Pharma/Nycomed Investigational Site
Ollioules, , France
Altana Pharma/Nycomed Investigational Site
Perpignan, , France
Altana Pharma/Nycomed Investigational Site
Saint-Laurent-du-Var, , France
Altana Pharma/Nycomed Investigational Site
Saint-Quentin, , France
Altana Pharma/Nycomed Investigational Site
Toulon, , France
Altana Pharma/Nycomed Investigational Site
Bad Homburg, , Germany
Altana Pharma/Nycomed Investigational Site
Dortmund, , Germany
Altana Pharma/Nycomed Investigational Site
Geesthacht, , Germany
Altana Pharma/Nycomed Investigational Site
Gelnhausen, , Germany
Altana Pharma/Nycomed Investigational Site
Göppingen, , Germany
Altana Pharma/Nycomed Investigational Site
Hanover, , Germany
Altana Pharma/Nycomed Investigational Site
Koblenz, , Germany
Altana Pharma/Nycomed Investigational Site
Landsberg/Lech, , Germany
Altana Pharma/Nycomed Investigational Site
Leonberg, , Germany
Altana Pharma/Nycomed Investigational Site
Marburg, , Germany
Altana Pharma/Nycomed Investigational Site
Saarbrücken, , Germany
Altana Pharma/Nycomed Investigational Site
Saarlouis, , Germany
Altana Pharma/Nycomed Investigational Site
Schwetzingen, , Germany
Altana Pharma/Nycomed Investigational Site
Sinsheim, , Germany
Altana Pharma/Nycomed Investigational Site
Weyhe, , Germany
Altana Pharma/Nycomed Investigational Site
Witten, , Germany
Altana Pharma/Nycomed Investigational Site
Budapest, , Hungary
Altana Pharma/Nycomed Investigational Site
Budapest, , Hungary
Altana Pharma/Nycomed Investigational Site
Budapest, , Hungary
Altana Pharma/Nycomed Investigational Site
Cegléd, , Hungary
Altana Pharma/Nycomed Investigational Site
Csorna, , Hungary
Altana Pharma/Nycomed Investigational Site
Érd, , Hungary
Altana Pharma/Nycomed Investigational Site
Győr, , Hungary
Altana Pharma/Nycomed Investigational Site
Hódmezovásárhely, , Hungary
Altana Pharma/Nycomed Investigational Site
Mátraháza, , Hungary
Altana Pharma/Nycomed Investigational Site
Nyiregyháza, , Hungary
Altana Pharma/Nycomed Investigational Site
Szentes, , Hungary
Altana Pharma/Nycomed Investigational Site
Szolnok, , Hungary
Altana Pharma/Nycomed Investigational Site
Bassano Del Grappa (VI), , Italy
Altana Pharma/Nycomed Investigational Site
Cisanello (PI), , Italy
Altana Pharma/Nycomed Investigational Site
Foggia, , Italy
Altana Pharma/Nycomed Investigational Site
Genova, , Italy
Altana Pharma/Nycomed Investigational Site
Milan, , Italy
Altana Pharma/Nycomed Investigational Site
Modena, , Italy
Altana Pharma/Nycomed Investigational Site
Pavullo Nel Frignano (MO), , Italy
Altana Pharma/Nycomed Investigational Site
Pordenone, , Italy
Altana Pharma/Nycomed Investigational Site
Reggio Emilia, , Italy
Altana Pharma/Nycomed Investigational Site
Verona, , Italy
Altana Pharma/Nycomed Investigational Site
A Coruña, , Spain
Altana Pharma/Nycomed Investigational Site
Alicante, , Spain
Altana Pharma/Nycomed Investigational Site
Baracaldo (Vizcaya), , Spain
Altana Pharma/Nycomed Investigational Site
Candia, , Spain
Altana Pharma/Nycomed Investigational Site
Escaldes-Engordany, , Spain
Altana Pharma/Nycomed Investigational Site
Galdakao, , Spain
Altana Pharma/Nycomed Investigational Site
Guadalajara, , Spain
Altana Pharma/Nycomed Investigational Site
Jerez de la Frontera, , Spain
Altana Pharma/Nycomed Investigational Site
Lleida, , Spain
Altana Pharma/Nycomed Investigational Site
Lugo, , Spain
Altana Pharma/Nycomed Investigational Site
Madrid, , Spain
Altana Pharma/Nycomed Investigational Site
Madrid, , Spain
Altana Pharma/Nycomed Investigational Site
Madrid, , Spain
Altana Pharma/Nycomed Investigational Site
Mostoles Madrid, , Spain
Altana Pharma/Nycomed Investigational Site
Pozuelo de Alarcón, , Spain
Altana Pharma/Nycomed Investigational Site
Requena, , Spain
Altana Pharma/Nycomed Investigational Site
Sant Cugat del Vallès, , Spain
Altana Pharma/Nycomed Investigational Site
Santa Cruz de Tenerife, , Spain
Altana Pharma/Nycomed Investigational Site
Seville, , Spain
Altana Pharma/Nycomed Investigational Site
Valencia, , Spain
Altana Pharma/Nycomed Investigational Site
Valencia, , Spain
Altana Pharma/Nycomed Investigational Site
Valencia, , Spain
Altana Pharma/Nycomed Investigational Site
Valencia, , Spain
Altana Pharma/Nycomed Investigational Site
Ashford, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Atherstone, Warwick, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Barry, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Bexhill-on-Sea, East Sussex, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Bolton, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Bolton Lancs, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Chesterfield, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Chesterfield Derbyshire, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Chippenham, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Co. Antrim, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Darlington, Co. Durham, , United Kingdom
Altana Pharma/Nycomed Investigational Site
East Sussex, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Glasgow, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Harrow, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Keresely End, Coventry, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Plymouth, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Sheffield, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Solihull, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Swindon, Wilts, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Trowbridge, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Watford, , United Kingdom
Altana Pharma/Nycomed Investigational Site
Yaxley, , United Kingdom
Countries
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References
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Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703. doi: 10.1016/S0140-6736(09)61252-6.
Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.
Other Identifiers
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2006-004508-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BY217/M2-128
Identifier Type: -
Identifier Source: org_study_id