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Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)

NCT ID: NCT00313209

Last Updated: 2016-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

933 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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Roflumilast Salmeterol COPD Chronic obstructive pulmonary disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Roflumilast

Roflumilast 500 µg

underlying medication: salmeterol 50 μg, twice daily, inhaled

Group Type ACTIVE_COMPARATOR

Roflumilast

Intervention Type DRUG

500 µg, once daily, oral administration in the morning

Placebo

Placebo

underlying medication: salmeterol 50 μg, twice daily, inhaled

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once daily

Interventions

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Roflumilast

500 µg, once daily, oral administration in the morning

Intervention Type DRUG

Placebo

once daily

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

* COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Altana Pharma/Nycomed Investigational Site

Linz, , Austria

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Neusiedl/See, , Austria

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Perg, , Austria

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Salzburg, , Austria

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Sankt Pölten, , Austria

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Steyr, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Wiener Neustadt, , Austria

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Zwettl Stadt, , Austria

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Arlon, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Duffel, , Belgium

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Genk, , Belgium

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Gilly, , Belgium

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Halen, , Belgium

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Jette, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Malmedy, , Belgium

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Montigny-le-Tilleul, , Belgium

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Namur, , Belgium

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Veurne, , Belgium

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Ajax, Ontario, , Canada

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Halifax, N.S., , Canada

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Hamilton, , Canada

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Hamilton, Ontario, , Canada

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Laval, , Canada

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London, , Canada

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Mirabel, , Canada

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Montreal, , Canada

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Montreal, , Canada

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Montreal, PQ, , Canada

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New Market, on, , Canada

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North Bay, , Canada

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Ontario, , Canada

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Ottawa, , Canada

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Québec, , Canada

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Regina, Saskatchewan, , Canada

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Saint John, , Canada

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Sainte-Foy, Quebec, , Canada

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Saskatoon SK, , Canada

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Sherbrooke, PQ, , Canada

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Toronto, on, , Canada

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Toronto, on, , Canada

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Vancouver, BC, , Canada

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Windsor, , Canada

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Winnipeg MB, , Canada

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Woodstock, , Canada

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Beausoleil, , France

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Beuvry, , France

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Chauny, , France

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Grasse, , France

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Grenoble, , France

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Lille, , France

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Lyon, , France

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Martigues, , France

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Montpellier, , France

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Nantes, , France

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Nice, , France

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Nice, , France

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Nîmes, , France

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Saint-Laurent-du-Var, , France

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Saint-Quentin, , France

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Trélazé, , France

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Aschaffenburg, , Germany

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Bochum, , Germany

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Bonn, , Germany

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Cologne, , Germany

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Geesthacht, , Germany

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Gelnhausen, , Germany

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Großhansdorf, , Germany

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Hanover, , Germany

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Koblenz, , Germany

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Marburg, , Germany

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Saarbrücken, , Germany

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Schwetzingen, , Germany

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Sinsheim, , Germany

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Surwold, , Germany

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Witten, , Germany

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Würzburg, , Germany

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Bari, , Italy

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Bologna, , Italy

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Catania, , Italy

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Cisanello (PI), , Italy

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Genova, , Italy

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Livorno, , Italy

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Milan, , Italy

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Pordenone, , Italy

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Roma, , Italy

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Saluzzo (CN), , Italy

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Torino, , Italy

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Tradate (VA), , Italy

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Verona, , Italy

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Vittorio Veneto (TV), , Italy

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Alkmaar, , Netherlands

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Almelo, , Netherlands

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Eindhoven, , Netherlands

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Helmond, , Netherlands

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Schiedam, , Netherlands

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Zwolle, , Netherlands

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Cape Town, , South Africa

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Alicante, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Elche (Alicante), , Spain

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Fuentesnuevas, Ponferrada (León), , Spain

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Guadalajara, , Spain

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Laredo (Cantabria), , Spain

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Mataró, Barcelona, , Spain

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Petrer (Alicante), , Spain

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Sabadell, , Spain

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Tarrasa (Barcelona), , Spain

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Torrelavega (Cantabria), , Spain

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Belfast, , United Kingdom

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Belfast, , United Kingdom

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Belfast, , United Kingdom

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Bexhill-on-Sea, East Sussex, , United Kingdom

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Bradford, , United Kingdom

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Bradford on Avon, Wiltshire, , United Kingdom

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Chesterfield Derbyshire, , United Kingdom

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Coleraine, , United Kingdom

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Cookstown, , United Kingdom

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East Sussex, , United Kingdom

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Edinburgh, , United Kingdom

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Glasgow, , United Kingdom

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Hastings, , United Kingdom

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Middlessex, , United Kingdom

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Sunbury on Thames, Middlessex, , United Kingdom

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Watford, , United Kingdom

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Countries

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Austria Belgium Canada France Germany Italy Netherlands South Africa Spain United Kingdom

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.

Reference Type RESULT
PMID: 19716961 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20102307 (View on PubMed)

Other Identifiers

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2005-005080-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BY217/M2-127

Identifier Type: -

Identifier Source: org_study_id