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

> **NCT00424268** · PHASE3 · COMPLETED · sponsor: **AstraZeneca** · enrollment: 743 (actual)

## Conditions studied

- Chronic Obstructive Pulmonary Disease

## Interventions

- **DRUG:** Roflumilast
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT00424268
- **Lead sponsor:** AstraZeneca
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-01
- **Primary completion:** 2008-01
- **Final completion:** 2008-07
- **Target enrollment:** 743 (ACTUAL)
- **Last updated:** 2016-12-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00424268

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00424268, "Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT00424268. Licensed CC0.

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