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

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 will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

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:

Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]

Secondary Outcome Measures:

Post-bronchodilator FEV1 [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
COPD Exacerbation Rate (Moderate or Severe) [ Time Frame: 24 weeks treatment period ] [ Designated as safety issue: No ]
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year.

A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].
Transition Dyspnea Index (TDI) Focal Score [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]
The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked:
- Functional Impairment
- Magnitude of Task
- Magnitude of Effort
At each of the post-randomization visits questions from the TDI were asked related to 3 components:

Change in
- Functional Impairment
- Magnitude of Task
- Magnitude of Effort
Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.
Shortness of Breath Questionnaire (SOBQ) Total Score [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]
Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living.

The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient.

For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is "not at all breathless" and five is "maximally breathless or too breathless to do the activity".

Enrollment:	743
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
Active Comparator: Roflumilast Roflumilast 500 µg underlying medication: tiotropium 18 µg, once daily, inhaled	Drug: Roflumilast 500 µg, once daily, oral administration in the morning
Placebo Comparator: Placebo Placebo underlying medication: tiotropium 18 µg, once daily, inhaled	Drug: Placebo once daily

Eligibility

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

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

Contacts and Locations

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

Show 103 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 ClinicalTrials.gov Identifier (NCT Number):

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
ClinicalTrials.gov Identifier:	NCT00424268 History of Changes
Other Study ID Numbers:	BY217/M2-128, 2006-004508-37
Study First Received:	January 18, 2007
Results First Received:	March 17, 2011
Last Updated:	August 3, 2011
Health Authority:	Austria: Federal Office for Safety in Health Care; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by ALTANA Pharma:

COPD
Roflumilast

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012