Clinical trial

Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients…

NCT00424268 · AstraZeneca, Industry · Completed

Key facts

NCT number NCT00424268
Title Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)
Official title Effect of Roflumilast in COPD Patients Treated With Tiotropium. A 24-week, Double-blind Study With 500 µg Roflumilast Once Daily Versus Placebo. The HELIOS Study
Acronym HELIOS
Lead sponsor AstraZeneca, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Chronic Obstructive Pulmonary Disease
Intervention type Drug
Interventions Roflumilast, Placebo
Enrollment 743
Start date Jan 1, 2007
Primary completion Jan 1, 2008
Completion Jul 1, 2008
First posted Jan 19, 2007
Last update posted Dec 5, 2016
Countries Austria, France, Germany, Hungary, Italy, Spain, United Kingdom

At a glance

  • 100–999 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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