Chronic Obstructive Pulmonary Disease Clinical Trial
— HELIOSOfficial title:
Effect of Roflumilast in COPD Patients Treated With Tiotropium. A 24-week, Double-blind Study With 500 µg Roflumilast Once Daily Versus Placebo. The HELIOS Study
The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.
Status | Completed |
Enrollment | 743 |
Est. completion date | July 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | 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 | |
France | Altana Pharma/Nycomed Investigational Site | Beuvry | |
France | Altana Pharma/Nycomed Investigational Site | Chauny Cedex | |
France | Altana Pharma/Nycomed Investigational Site | Grasse | |
France | Altana Pharma/Nycomed Investigational Site | Lyon | |
France | Altana Pharma/Nycomed Investigational Site | Martigues Cedex | |
France | Altana Pharma/Nycomed Investigational Site | Montigny-Les-Metz | |
France | Altana Pharma/Nycomed Investigational Site | Nantes | |
France | Altana Pharma/Nycomed Investigational Site | Nice | |
France | Altana Pharma/Nycomed Investigational Site | Nimes | |
France | Altana Pharma/Nycomed Investigational Site | Nimes Cedex 9 | |
France | Altana Pharma/Nycomed Investigational Site | Ollioules | |
France | Altana Pharma/Nycomed Investigational Site | Perpignan Cedex | |
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 | |
Germany | 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 | Hannover | |
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 | |
Hungary | 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 | Cegled | |
Hungary | Altana Pharma/Nycomed Investigational Site | Csorna | |
Hungary | Altana Pharma/Nycomed Investigational Site | Erd | |
Hungary | Altana Pharma/Nycomed Investigational Site | Györ | |
Hungary | Altana Pharma/Nycomed Investigational Site | Hódmezovásárhely | |
Hungary | Altana Pharma/Nycomed Investigational Site | Matrahaza | |
Hungary | Altana Pharma/Nycomed Investigational Site | Nyiregyháza | |
Hungary | Altana Pharma/Nycomed Investigational Site | Szentes | |
Hungary | Altana Pharma/Nycomed Investigational Site | Szolnok | |
Italy | 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 | Milano | |
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 | |
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 | La Coruna | |
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 Valles | |
Spain | Altana Pharma/Nycomed Investigational Site | Santa Cruz de Tenerife | |
Spain | Altana Pharma/Nycomed Investigational Site | Sevilla | |
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 | |
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
Takeda |
Austria, France, Germany, Hungary, Italy, Spain, United Kingdom,
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 clin — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) | Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L] | Change from baseline over 24 weeks of treatment | No |
Secondary | Post-bronchodilator FEV1 | Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L] | Change from baseline over 24 weeks of treatment | No |
Secondary | COPD Exacerbation Rate (Moderate or Severe) | Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005]. |
24 weeks treatment period | No |
Secondary | Transition Dyspnea Index (TDI) Focal Score | The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: Functional Impairment Magnitude of Task Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in Functional Impairment Magnitude of Task Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9. |
Change from baseline over 24 weeks of treatment | No |
Secondary | Shortness of Breath Questionnaire (SOBQ) Total Score | Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is "not at all breathless" and five is "maximally breathless or too breathless to do the activity". |
Change from baseline over 24 weeks of treatment | No |
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