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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— EOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313209
• Other study ID #: BY217/M2-127
• Secondary ID: 2005-005080-28
• Status: Completed
• Phase: Phase 3
• First received: April 11, 2006
• Last updated: May 4, 2012
• Start date: April 2006
• Est. completion date: February 2008

Study information

• Verified date: April 2011
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyNetherlands: Medicines Evaluation Board (MEB)South Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 933
• Est. completion date: February 2008
• Est. primary completion date: July 2007
• 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

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Roflumilast
500 µg, once daily, oral administration in the morning
• Placebo
once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

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

References & Publications (1)

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

Outcome

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 (Mild, Moderate or Severe)	Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or 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 [ATS / 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