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

Sponsor
AstraZeneca
Study ID
NCT00424268
Phase
PHASE3
Status
Completed

Conditions

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 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.

Key Dates

Start date
Jan 31, 2007
Status verified
Sep 2016
Primary completion
Jan 31, 2008
Completion
Jul 31, 2008

Study Design

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

Arms

  • Active Comparator: Roflumilast
    Roflumilast 500 µg underlying medication: tiotropium 18 µg, once daily, inhaled
  • Placebo Comparator: Placebo
    Placebo underlying medication: tiotropium 18 µg, once 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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