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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: Roflumilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00313209

2005-005080-28 (EudraCT Number)

BY217/M2-127

Details and patient eligibility

About

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.

Enrollment: 933 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

933 participants in 2 patient groups, including a placebo group

Roflumilast

Active Comparator group

Description:

Roflumilast 500 µg underlying medication: salmeterol 50 μg, twice daily, inhaled

Treatment:

Drug: Roflumilast

Placebo

Placebo Comparator group

Description:

Placebo underlying medication: salmeterol 50 μg, twice daily, inhaled

Treatment:

Drug: Placebo