Clinical trial NCT00313209: Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)
Official title: Effect of Roflumilast in COPD Patients Treated With Salmeterol. A 24-week, Double-blind Study With 500 μg Roflumilast Once Daily Versus Placebo. The EOS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Roflumilast
Salmeterol
COPD
Chronic obstructive pulmonary disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 933
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 on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. 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
* FEV1/FVC ratio (post-bronchodilator) ≤ 70%
* FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted

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 (Mild, 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: Linz
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Neusiedl/See
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Perg
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Salzburg
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: St. Pölten
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Steyr
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Wiener Neustadt
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Wien
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Wien
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Wien
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Zwettl
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Arlon
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Bruxelles
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Bruxelles
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Duffel
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Genk
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Gilly
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Halen
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Jette
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Leuven
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Liège
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Malmedy
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Montigny-Le-Tilleul
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Namur
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Veurne
country: Belgium
facility: Altana Pharma/Nycomed Investigational Site
city: Ajax, Ontario
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Halifax, N.S.
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Hamilton, Ontario
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Hamilton
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Laval
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: London
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Mirabel
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Montreal, PQ
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Montreal
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Montreal
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: New Market, ON
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: North Bay
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Ontario
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Ottawa
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Quebec City
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Regina, Saskatchewan
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Saint John
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Sainte-Foy, Quebec
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Saskatoon SK
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Sherbrooke, PQ
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Toronto, ON
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Toronto, ON
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Vancouver, BC
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Windsor
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Winnipeg MB
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Woodstock
country: Canada
facility: Altana Pharma/Nycomed Investigational Site
city: Beausoleil
country: France
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: Grenoble
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Lille Cedex
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: Montpellier Cedex
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Nantes
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Nice Cedex 1
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Nice
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Nimes
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: Trelaze
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Aschaffenburg
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Bochum
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Bonn
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: Großhansdorf
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: Köln
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Marburg
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Saarbruecken
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: Surwold
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Witten
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Würzburg
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Bari
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Bologna
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Catania
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Cisanello (PI)
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Genova
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Livorno
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Milano
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Pordenone
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Roma
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Saluzzo (CN)
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Torino
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Tradate (VA)
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Verona
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Vittorio Veneto (TV)
country: Italy
facility: Altana Pharma/Nycomed Investigational Site
city: Alkmaar
country: Netherlands
facility: Altana Pharma/Nycomed Investigational Site
city: Almelo
country: Netherlands
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city: Eindhoven
country: Netherlands
facility: Altana Pharma/Nycomed Investigational Site
city: Helmond
country: Netherlands
facility: Altana Pharma/Nycomed Investigational Site
city: Schiedam
country: Netherlands
facility: Altana Pharma/Nycomed Investigational Site
city: Zwolle
country: Netherlands
facility: Altana Pharma/Nycomed Investigational Site
city: Kapstadt
country: South Africa
facility: Altana Pharma/Nycomed Investigational Sites
city: Alicante
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Elche (Alicante)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Fuentesnuevas, Ponferrada (León)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Guadalajara
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Laredo (Cantabria)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Mataró, Barcelona
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Petrer (Alicante)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Sabadell
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Tarrasa (Barcelona)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Torrelavega (Cantabria)
country: Spain
facility: Altana Pharma/Nycomed Investigational Site
city: Belfast
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Belfast
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Belfast
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: Bradford on Avon, Wiltshire
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Bradford
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Chesterfield Derbyshire
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Coleraine
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Cookstown
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: East Sussex
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Edinburg
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Glasgow
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Hastings
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Middlessex
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Sunbury on Thames, Middlessex
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Watford
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.