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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00313209
First received: April 11, 2006
Last updated: May 4, 2012
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Roflumilast
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]
    Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]


Secondary Outcome Measures:
  • Post-bronchodilator FEV1 [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]
    Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]

  • COPD Exacerbation Rate (Mild, Moderate or Severe) [ Time Frame: 24 weeks treatment period ] [ Designated as safety issue: No ]

    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].


  • Transition Dyspnea Index (TDI) Focal Score [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]

    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.


  • Shortness of Breath Questionnaire (SOBQ) Total Score [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]

    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".



Enrollment: 933
Study Start Date: April 2006
Study Completion Date: February 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Roflumilast

Roflumilast 500 µg

underlying medication: salmeterol 50 μg, twice daily, inhaled

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

Placebo

underlying medication: salmeterol 50 μg, twice daily, inhaled

Drug: Placebo
once daily

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313209

  Show 134 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: José L Izquierdo, MD Servicio de Neumología, Hospital General Universitario De Guadalajara, Espana
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00313209     History of Changes
Other Study ID Numbers: BY217/M2-127, 2005-005080-28
Study First Received: April 11, 2006
Results First Received: March 17, 2011
Last Updated: May 4, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Takeda:
Roflumilast
Salmeterol
COPD
Chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Salmeterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014