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

October 24, 2016 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

743

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldbach, Austria, 8330
        • Altana Pharma/Nycomed Investigational Site
      • Gänserndorf, Austria, 2230
        • Altana Pharma/Nycomed Investigational Site
      • Hallein, Austria, 5400
        • Altana Pharma/Nycomed Investigational Site
      • Linz, Austria, 4040
        • Altana Pharma/Nycomed Investigational Site
      • Spittal an der Drau, Austria, 9800
        • Altana Pharma/Nycomed Investigational Site
  • France
      • Beuvry, France, 62660
        • Altana Pharma/Nycomed Investigational Site
      • Chauny Cedex, France, 2303
        • Altana Pharma/Nycomed Investigational Site
      • Grasse, France, 6130
        • Altana Pharma/Nycomed Investigational Site
      • Lyon, France, 69003
        • Altana Pharma/Nycomed Investigational Site
      • Martigues Cedex, France, 13695
        • Altana Pharma/Nycomed Investigational Site
      • Montigny-Les-Metz, France, 57950
        • Altana Pharma/Nycomed Investigational Site
      • Nantes, France, 44000
        • Altana Pharma/Nycomed Investigational Site
      • Nice, France, 6000
        • Altana Pharma/Nycomed Investigational Site
      • Nimes, France, 30900
        • Altana Pharma/Nycomed Investigational Site
      • Nimes Cedex 9, France, 30029
        • Altana Pharma/Nycomed Investigational Site
      • Ollioules, France, 83190
        • Altana Pharma/Nycomed Investigational Site
      • Perpignan Cedex, France, 66046
        • Altana Pharma/Nycomed Investigational Site
      • Saint Laurent Du Var, France, 6700
        • Altana Pharma/Nycomed Investigational Site
      • Saint-Quentin, France, 2100
        • Altana Pharma/Nycomed Investigational Site
      • Toulon, France, 83000
        • Altana Pharma/Nycomed Investigational Site
  • Germany
      • Bad Homburg, Germany, 61348
        • Altana Pharma/Nycomed Investigational Site
      • Dortmund, Germany, 44263
        • Altana Pharma/Nycomed Investigational Site
      • Geesthacht, Germany, 21502
        • Altana Pharma/Nycomed Investigational Site
      • Gelnhausen, Germany, 63571
        • Altana Pharma/Nycomed Investigational Site
      • Göppingen, Germany, 73033
        • Altana Pharma/Nycomed Investigational Site
      • Hannover, Germany, 30167
        • Altana Pharma/Nycomed Investigational Site
      • Koblenz, Germany, 56068
        • Altana Pharma/Nycomed Investigational Site
      • Landsberg/Lech, Germany, 86899
        • Altana Pharma/Nycomed Investigational Site
      • Leonberg, Germany, 71229
        • Altana Pharma/Nycomed Investigational Site
      • Marburg, Germany, 35037
        • Altana Pharma/Nycomed Investigational Site
      • Saarbrücken, Germany, 66111
        • Altana Pharma/Nycomed Investigational Site
      • Saarlouis, Germany, 66740
        • Altana Pharma/Nycomed Investigational Site
      • Schwetzingen, Germany, 68723
        • Altana Pharma/Nycomed Investigational Site
      • Sinsheim, Germany, 74889
        • Altana Pharma/Nycomed Investigational Site
      • Weyhe, Germany, 28844
        • Altana Pharma/Nycomed Investigational Site
      • Witten, Germany, 58452
        • Altana Pharma/Nycomed Investigational Site
  • Hungary
      • Budapest, Hungary, 1134
        • Altana Pharma/Nycomed Investigational Site
      • Budapest, Hungary, 1046
        • Altana Pharma/Nycomed Investigational Site
      • Budapest, Hungary, 1529
        • Altana Pharma/Nycomed Investigational Site
      • Cegled, Hungary, 2700
        • Altana Pharma/Nycomed Investigational Site
      • Csorna, Hungary, 9300
        • Altana Pharma/Nycomed Investigational Site
      • Erd, Hungary, 2030
        • Altana Pharma/Nycomed Investigational Site
      • Györ, Hungary, 9024
        • Altana Pharma/Nycomed Investigational Site
      • Hódmezovásárhely, Hungary, 6800
        • Altana Pharma/Nycomed Investigational Site
      • Matrahaza, Hungary, 3233
        • Altana Pharma/Nycomed Investigational Site
      • Nyiregyháza, Hungary, 4412
        • Altana Pharma/Nycomed Investigational Site
      • Szentes, Hungary, 6600
        • Altana Pharma/Nycomed Investigational Site
      • Szolnok, Hungary, 5006
        • Altana Pharma/Nycomed Investigational Site
  • Italy
      • Bassano Del Grappa (VI), Italy, 36061
        • Altana Pharma/Nycomed Investigational Site
      • Cisanello (PI), Italy, 56100
        • Altana Pharma/Nycomed Investigational Site
      • Foggia, Italy, 71100
        • Altana Pharma/Nycomed Investigational Site
      • Genova, Italy, 16132
        • Altana Pharma/Nycomed Investigational Site
      • Milano, Italy, 20153
        • Altana Pharma/Nycomed Investigational Site
      • Modena, Italy, 41100
        • Altana Pharma/Nycomed Investigational Site
      • Pavullo nel Frignano (MO), Italy, 41020
        • Altana Pharma/Nycomed Investigational Site
      • Pordenone, Italy, 33170
        • Altana Pharma/Nycomed Investigational Site
      • Reggio Emilia, Italy, 42100
        • Altana Pharma/Nycomed Investigational Site
      • Verona, Italy, 30012
        • Altana Pharma/Nycomed Investigational Site
  • Spain
      • Alicante, Spain, 3010
        • Altana Pharma/Nycomed Investigational Site
      • Baracaldo (Vizcaya), Spain, 48903
        • Altana Pharma/Nycomed Investigational Site
      • Candia, Spain, 28935
        • Altana Pharma/Nycomed Investigational Site
      • Escaldes-Engordany, Spain, AD700
        • Altana Pharma/Nycomed Investigational Site
      • Galdakao, Spain, 48960
        • Altana Pharma/Nycomed Investigational Site
      • Guadalajara, Spain, 19002
        • Altana Pharma/Nycomed Investigational Site
      • Jerez de la Frontera, Spain, 11407
        • Altana Pharma/Nycomed Investigational Site
      • La Coruna, Spain, 15006
        • Altana Pharma/Nycomed Investigational Site
      • Lleida, Spain, 25198
        • Altana Pharma/Nycomed Investigational Site
      • Lugo, Spain, 27004
        • Altana Pharma/Nycomed Investigational Site
      • Madrid, Spain, 28007
        • Altana Pharma/Nycomed Investigational Site
      • Madrid, Spain, 28034
        • Altana Pharma/Nycomed Investigational Site
      • Madrid, Spain, 28047
        • Altana Pharma/Nycomed Investigational Site
      • Mostoles Madrid, Spain, 28935
        • Altana Pharma/Nycomed Investigational Site
      • Pozuelo de Alarcón, Spain, 28223
        • Altana Pharma/Nycomed Investigational Site
      • Requena, Spain, 46340
        • Altana Pharma/Nycomed Investigational Site
      • Sant Cugat del Valles, Spain, 8190
        • Altana Pharma/Nycomed Investigational Site
      • Santa Cruz de Tenerife, Spain, 38010
        • Altana Pharma/Nycomed Investigational Site
      • Sevilla, Spain, 41013
        • Altana Pharma/Nycomed Investigational Site
      • Valencia, Spain, 46015
        • Altana Pharma/Nycomed Investigational Site
      • Valencia, Spain, 46017
        • Altana Pharma/Nycomed Investigational Site
      • Valencia, Spain, 46010
        • Altana Pharma/Nycomed Investigational Site
      • Valencia, Spain, 46014
        • Altana Pharma/Nycomed Investigational Site
  • United Kingdom
      • Ashford, United Kingdom, TW15 3RN
        • Altana Pharma/Nycomed Investigational Site
      • Atherstone, Warwick, United Kingdom, CV9 1EU
        • Altana Pharma/Nycomed Investigational Site
      • Barry, United Kingdom, CS62 7EB
        • Altana Pharma/Nycomed Investigational Site
      • Bexhill-on-Sea, East Sussex, United Kingdom, TN40 1JJ
        • Altana Pharma/Nycomed Investigational Site
      • Bolton, United Kingdom
        • Altana Pharma/Nycomed Investigational Site
      • Bolton Lancs, United Kingdom, BL3 6TL
        • Altana Pharma/Nycomed Investigational Site
      • Chesterfield, United Kingdom, S40 4TF
        • Altana Pharma/Nycomed Investigational Site
      • Chesterfield Derbyshire, United Kingdom, S40 4TF
        • Altana Pharma/Nycomed Investigational Site
      • Chippenham, United Kingdom, SN15 1HP
        • Altana Pharma/Nycomed Investigational Site
      • Co. Antrim, United Kingdom, BT38 8TP
        • Altana Pharma/Nycomed Investigational Site
      • Darlington, Co. Durham, United Kingdom, DL3 6HX
        • Altana Pharma/Nycomed Investigational Site
      • East Sussex, United Kingdom, TN39 5HE
        • Altana Pharma/Nycomed Investigational Site
      • Glasgow, United Kingdom, G45 9AW
        • Altana Pharma/Nycomed Investigational Site
      • Harrow, United Kingdom, HA3 7LT
        • Altana Pharma/Nycomed Investigational Site
      • Keresely End, Coventry, United Kingdom, CV7 8LA
        • Altana Pharma/Nycomed Investigational Site
      • Plymouth, United Kingdom, PL6 7TH
        • Altana Pharma/Nycomed Investigational Site
      • Sheffield, United Kingdom, S39DA
        • Altana Pharma/Nycomed Investigational Site
      • Solihull, United Kingdom, B91 2JL
        • Altana Pharma/Nycomed Investigational Site
      • Swindon, Wilts, United Kingdom, SN25 4YZ
        • Altana Pharma/Nycomed Investigational Site
      • Trowbridge, United Kingdom, BA14 9AR
        • Altana Pharma/Nycomed Investigational Site
      • Watford, United Kingdom, WD25 0EA
        • Altana Pharma/Nycomed Investigational Site
      • Yaxley, United Kingdom, PE7 3JL
        • Altana Pharma/Nycomed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Time Frame: Change from baseline over 24 weeks of treatment
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]
Change from baseline over 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-bronchodilator FEV1
Time Frame: Change from baseline over 24 weeks of treatment
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
Change from baseline over 24 weeks of treatment
Transition Dyspnea Index (TDI) Focal Score
Time Frame: Change from baseline over 24 weeks of treatment
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.
Change from baseline over 24 weeks of treatment
Shortness of Breath Questionnaire (SOBQ) Total Score
Time Frame: Change from baseline over 24 weeks of treatment
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".
Change from baseline over 24 weeks of treatment
COPD Exacerbation Rate (Moderate or Severe)
Time Frame: 24 weeks treatment period
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].
24 weeks treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

January 18, 2007

First Submitted That Met QC Criteria

January 18, 2007

First Posted (Estimate)

January 19, 2007

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY217/M2-128
  • 2006-004508-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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