Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: Roflumilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00424268

2006-004508-37 (EudraCT Number)

BY217/M2-128

Details and patient eligibility

About

The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

Enrollment: 743 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 and chronic productive cough for 3 months in each of the 2 years prior to baseline visit
• FEV1/FVC ratio (post-bronchodilator) ≤ 70%
• FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
• Treated with tiotropium for at least 3 months before enrollment
• At least 28 puffs of rescue medication during last week prior to randomization

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

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743 participants in 2 patient groups, including a placebo group

Roflumilast

Active Comparator group

Description:

Roflumilast 500 µg underlying medication: tiotropium 18 µg, once daily, inhaled

Treatment:

Drug: Roflumilast

Placebo

Placebo Comparator group

Description:

Placebo underlying medication: tiotropium 18 µg, once daily, inhaled

Treatment:

Drug: Placebo