Clinical trial NCT00424268: Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Roflumilast
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-19
Enrollment: 743
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
timeFrame: Change from baseline over 24 weeks of treatment
Secondary outcomes:
measure: Post-bronchodilator FEV1
timeFrame: Change from baseline over 24 weeks of treatment
measure: COPD Exacerbation Rate (Moderate or Severe)
timeFrame: 24 weeks treatment period
measure: Transition Dyspnea Index (TDI) Focal Score
timeFrame: Change from baseline over 24 weeks of treatment
measure: Shortness of Breath Questionnaire (SOBQ) Total Score
timeFrame: Change from baseline over 24 weeks of treatment
Other outcomes:
Locations:
city: Feldbach
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Gänserndorf
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Hallein
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Linz
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Spittal an der Drau
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Beuvry
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Chauny Cedex
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Grasse
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Lyon
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Martigues Cedex
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Montigny-Les-Metz
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Nantes
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Nice
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Nimes Cedex 9
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Nimes
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Ollioules
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Perpignan Cedex
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Saint Laurent Du Var
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Saint-Quentin
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Toulon
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Bad Homburg
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Dortmund
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Geesthacht
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Gelnhausen
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Göppingen
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Hannover
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Koblenz
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Landsberg/Lech
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Leonberg
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Marburg
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Saarbrücken
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Saarlouis
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Schwetzingen
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Sinsheim
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Weyhe
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Witten
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Cegled
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Csorna
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Erd
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Györ
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Hódmezovásárhely
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Matrahaza
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Nyiregyháza
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Szentes
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Szolnok
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Bassano Del Grappa (VI)
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Cisanello (PI)
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Foggia
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Genova
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Milano
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Modena
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Pavullo nel Frignano (MO)
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Pordenone
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Reggio Emilia
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Verona
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Alicante
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Baracaldo (Vizcaya)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Candia
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Escaldes-Engordany
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Galdakao
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Guadalajara
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Jerez de la Frontera
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: La Coruna
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Lleida
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Lugo
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Mostoles Madrid
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Pozuelo de Alarcón
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Requena
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Sant Cugat del Valles
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Sevilla
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Valencia
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Valencia
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Valencia
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Valencia
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Ashford
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Atherstone, Warwick
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Barry
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Bexhill-on-Sea, East Sussex
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Bolton Lancs
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Bolton
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Chesterfield Derbyshire
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Chesterfield
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Chippenham
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Co. Antrim
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Darlington, Co. Durham
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: East Sussex
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Glasgow
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Harrow
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Keresely End, Coventry
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Plymouth
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Sheffield
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Solihull
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Swindon, Wilts
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Trowbridge
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Watford
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Yaxley
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.