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

Sponsor
AstraZeneca
Study ID
NCT00313209
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    500 µg, once daily, oral administration in the morning
  • Placebo — DRUG
    once daily

Study Details

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.

Key Dates

Start date
Apr 30, 2006
Status verified
Nov 2016
Primary completion
Jul 31, 2007
Completion
Feb 29, 2008

Study Design

Enrollment
933 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Roflumilast
    Roflumilast 500 µg underlying medication: salmeterol 50 μg, twice daily, inhaled
  • Placebo Comparator: Placebo
    Placebo underlying medication: salmeterol 50 μg, twice daily, inhaled

Primary Outcome Measure

Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Change from baseline over 24 weeks of treatment ]

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