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

This study has been completed.

First Received: January 18, 2007 Last Updated: December 12, 2008 History of Changes

Sponsor:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00424268

Purpose

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 consists of a baseline period (4 weeks) and a treatment period (24 weeks).The study will provide further data on safety and tolerability of roflumilast.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Roflumilast	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Official Title:	The HELIOS-Study: Effect of Roflumilast in COPD Patients Treated With Tiotropium. A 24-Week, Double-Blind Study With 500µg Roflumilast Once Daily Versus Placebo

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide Roflumilast Tiotropium

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

Lung function [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Other spirometry parameters; COPD symptoms; safety and tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	January 2007
Study Completion Date:	July 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator tiotropium 18 µg + 1 tablet roflumilast 500µg	Drug: Roflumilast COPD
2: Placebo Comparator tiotropium 18 µg + 1 tablet placebo	Drug: Roflumilast COPD

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 40 years
History of chronic obstructive pulmonary disease for at least 12 months prior to baseline visit
Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio (post-bronchodilator) less than or equal to 70%
FEV1 (post-bronchodilator) greater than or equal to 40% and less than or equal to 70% of predicted

Exclusion Criteria:

COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to the baseline visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424268

Show 104 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators

Principal Investigator:

Prof. L M Fabbri

University of Modena & Reggio Emilia, Department of Respiratory Diseases, Italy

More Information

No publications provided by ALTANA Pharma

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703.

Responsible Party:	Nycomed ( Nycomed )
Study ID Numbers:	BY217/M2-128
Study First Received:	January 18, 2007
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00424268 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ALTANA Pharma:

COPD
Roflumilast

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Respiration Disorders
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions

Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Peripheral Nervous System Agents
Tiotropium
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010