Chronic Obstructive Pulmonary DiseasePhase 3HELIOSNCT00424268

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

A Phase 3 study testing Roflumilast in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 103 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Roflumilast
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 743 participants
Where: 103 sitesin 7 countries
Study dates: Jan 2007to Jul 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

103 sites in 7 countries.

Country

City, postcode or hospital

103 sites in 7 countries

Spain23 sites

Altana Pharma/Nycomed Investigational Site
A Coruña, 15006
Altana Pharma/Nycomed Investigational Site
Alicante, 3010
Altana Pharma/Nycomed Investigational Site
Baracaldo (Vizcaya), 48903
Altana Pharma/Nycomed Investigational Site
Candia, 28935
Altana Pharma/Nycomed Investigational Site
Escaldes-Engordany, AD700
Altana Pharma/Nycomed Investigational Site
Galdakao, 48960
Altana Pharma/Nycomed Investigational Site
Guadalajara, 19002
Altana Pharma/Nycomed Investigational Site
Jerez de la Frontera, 11407
Altana Pharma/Nycomed Investigational Site
Lleida, 25198
Altana Pharma/Nycomed Investigational Site
Lugo, 27004
Altana Pharma/Nycomed Investigational Site
Madrid, 28007
Altana Pharma/Nycomed Investigational Site
Madrid, 28034
Altana Pharma/Nycomed Investigational Site
Madrid, 28047
Altana Pharma/Nycomed Investigational Site
Mostoles Madrid, 28935
Altana Pharma/Nycomed Investigational Site
Pozuelo de Alarcón, 28223
Altana Pharma/Nycomed Investigational Site
Requena, 46340
Altana Pharma/Nycomed Investigational Site
Sant Cugat del Vallès, 8190
Altana Pharma/Nycomed Investigational Site
Santa Cruz de Tenerife, 38010
Altana Pharma/Nycomed Investigational Site
Seville, 41013
Altana Pharma/Nycomed Investigational Site
Valencia, 46010
Altana Pharma/Nycomed Investigational Site
Valencia, 46014
Altana Pharma/Nycomed Investigational Site
Valencia, 46015
Altana Pharma/Nycomed Investigational Site
Valencia, 46017

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United Kingdom22 sites

Altana Pharma/Nycomed Investigational Site
Ashford, TW15 3RN
Altana Pharma/Nycomed Investigational Site
Atherstone, Warwick, CV9 1EU
Altana Pharma/Nycomed Investigational Site
Barry, CS62 7EB
Altana Pharma/Nycomed Investigational Site
Bexhill-on-Sea, East Sussex, TN40 1JJ
Altana Pharma/Nycomed Investigational Site
Bolton
Altana Pharma/Nycomed Investigational Site
Bolton Lancs, BL3 6TL
Altana Pharma/Nycomed Investigational Site
Chesterfield, S40 4TF
Altana Pharma/Nycomed Investigational Site
Chesterfield Derbyshire, S40 4TF
Altana Pharma/Nycomed Investigational Site
Chippenham, SN15 1HP
Altana Pharma/Nycomed Investigational Site
Co. Antrim, BT38 8TP
Altana Pharma/Nycomed Investigational Site
Darlington, Co. Durham, DL3 6HX
Altana Pharma/Nycomed Investigational Site
East Sussex, TN39 5HE
Altana Pharma/Nycomed Investigational Site
Glasgow, G45 9AW
Altana Pharma/Nycomed Investigational Site
Harrow, HA3 7LT
Altana Pharma/Nycomed Investigational Site
Keresely End, Coventry, CV7 8LA
Altana Pharma/Nycomed Investigational Site
Plymouth, PL6 7TH
Altana Pharma/Nycomed Investigational Site
Sheffield, S39DA
Altana Pharma/Nycomed Investigational Site
Solihull, B91 2JL
Altana Pharma/Nycomed Investigational Site
Swindon, Wilts, SN25 4YZ
Altana Pharma/Nycomed Investigational Site
Trowbridge, BA14 9AR
Altana Pharma/Nycomed Investigational Site
Watford, WD25 0EA
Altana Pharma/Nycomed Investigational Site
Yaxley, PE7 3JL

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Germany16 sites

Altana Pharma/Nycomed Investigational Site
Bad Homburg, 61348
Altana Pharma/Nycomed Investigational Site
Dortmund, 44263
Altana Pharma/Nycomed Investigational Site
Geesthacht, 21502
Altana Pharma/Nycomed Investigational Site
Gelnhausen, 63571
Altana Pharma/Nycomed Investigational Site
Göppingen, 73033
Altana Pharma/Nycomed Investigational Site
Hanover, 30167
Altana Pharma/Nycomed Investigational Site
Koblenz, 56068
Altana Pharma/Nycomed Investigational Site
Landsberg/Lech, 86899
Altana Pharma/Nycomed Investigational Site
Leonberg, 71229
Altana Pharma/Nycomed Investigational Site
Marburg, 35037
Altana Pharma/Nycomed Investigational Site
Saarbrücken, 66111
Altana Pharma/Nycomed Investigational Site
Saarlouis, 66740
Altana Pharma/Nycomed Investigational Site
Schwetzingen, 68723
Altana Pharma/Nycomed Investigational Site
Sinsheim, 74889
Altana Pharma/Nycomed Investigational Site
Weyhe, 28844
Altana Pharma/Nycomed Investigational Site
Witten, 58452

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France15 sites

Altana Pharma/Nycomed Investigational Site
Beuvry, 62660
Altana Pharma/Nycomed Investigational Site
Chauny, 2303
Altana Pharma/Nycomed Investigational Site
Grasse, 6130
Altana Pharma/Nycomed Investigational Site
Lyon, 69003
Altana Pharma/Nycomed Investigational Site
Martigues, 13695
Altana Pharma/Nycomed Investigational Site
Montigny-lès-Metz, 57950
Altana Pharma/Nycomed Investigational Site
Nantes, 44000
Altana Pharma/Nycomed Investigational Site
Nice, 6000
Altana Pharma/Nycomed Investigational Site
Nîmes, 30029
Altana Pharma/Nycomed Investigational Site
Nîmes, 30900
Altana Pharma/Nycomed Investigational Site
Ollioules, 83190
Altana Pharma/Nycomed Investigational Site
Perpignan, 66046
Altana Pharma/Nycomed Investigational Site
Saint-Laurent-du-Var, 6700
Altana Pharma/Nycomed Investigational Site
Saint-Quentin, 2100
Altana Pharma/Nycomed Investigational Site
Toulon, 83000

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Hungary12 sites

Altana Pharma/Nycomed Investigational Site
Budapest, 1046
Altana Pharma/Nycomed Investigational Site
Budapest, 1134
Altana Pharma/Nycomed Investigational Site
Budapest, 1529
Altana Pharma/Nycomed Investigational Site
Cegléd, 2700
Altana Pharma/Nycomed Investigational Site
Csorna, 9300
Altana Pharma/Nycomed Investigational Site
Érd, 2030
Altana Pharma/Nycomed Investigational Site
Győr, 9024
Altana Pharma/Nycomed Investigational Site
Hódmezovásárhely, 6800
Altana Pharma/Nycomed Investigational Site
Mátraháza, 3233
Altana Pharma/Nycomed Investigational Site
Nyiregyháza, 4412
Altana Pharma/Nycomed Investigational Site
Szentes, 6600
Altana Pharma/Nycomed Investigational Site
Szolnok, 5006

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Italy10 sites

Altana Pharma/Nycomed Investigational Site
Bassano Del Grappa (VI), 36061
Altana Pharma/Nycomed Investigational Site
Cisanello (PI), 56100
Altana Pharma/Nycomed Investigational Site
Foggia, 71100
Altana Pharma/Nycomed Investigational Site
Genova, 16132
Altana Pharma/Nycomed Investigational Site
Milan, 20153
Altana Pharma/Nycomed Investigational Site
Modena, 41100
Altana Pharma/Nycomed Investigational Site
Pavullo Nel Frignano (MO), 41020
Altana Pharma/Nycomed Investigational Site
Pordenone, 33170
Altana Pharma/Nycomed Investigational Site
Reggio Emilia, 42100
Altana Pharma/Nycomed Investigational Site
Verona, 30012

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Austria5 sites

Altana Pharma/Nycomed Investigational Site
Feldbach, 8330
Altana Pharma/Nycomed Investigational Site
Gänserndorf, 2230
Altana Pharma/Nycomed Investigational Site
Hallein, 5400
Altana Pharma/Nycomed Investigational Site
Linz, 4040
Altana Pharma/Nycomed Investigational Site
Spittal an der Drau, 9800

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About this study

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

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Roflumilast, Placebo
Keywords: COPD, Roflumilast
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RoflumilastDrug
500 µg, once daily, oral administration in the morning
PlaceboDrug
once daily

Study groups in NCT00424268
Study group	Role	What they receive
Roflumilast	Active comparator	Roflumilast 500 µg underlying medication: tiotropium 18 µg, once daily, inhaled Receives: Drug: Roflumilast
Placebo	Placebo comparator	Placebo underlying medication: tiotropium 18 µg, once daily, inhaled Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Jul 2008

First posted19 Jan 2007 (estimated)
Study startJan 2007
Primary completionJan 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 743 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00424268
Sponsor's protocol ID: BY217/M2-128
Other IDs: 2006-004508-37
Acronym: HELIOS
Status last verified: Sep 2016
First submitted: 18 Jan 2007
Last updated: 5 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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. doi: 10.1016/S0140-6736(09)61252-6.
PubMed 19716961
Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.
PubMed 20102307

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00424268
Acronym / sponsor ID: HELIOS / BY217/M2-128
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, Roflumilast
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 743 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Jan 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 19 Jan 2007 (estimated)
Results: Posted 19 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Roflumilast	Active comparator	Drug: RoflumilastRoflumilast 500 µg underlying medication: tiotropium 18 µg, once daily, inhaled
Placebo	Placebo comparator	Drug: PlaceboPlacebo underlying medication: tiotropium 18 µg, once daily, inhaled

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Roflumilast500 µg, once daily, oral administration in the morning	Drug	Roflumilast
Placeboonce daily	Drug	Placebo

Primary outcome

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]

4 secondary outcomes

Post-bronchodilator FEV1
Time frame: Change from baseline over 24 weeks of treatment
COPD Exacerbation Rate (Moderate or Severe)
Time frame: 24 weeks treatment period
Transition Dyspnea Index (TDI) Focal Score
Time frame: 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

Results and safety

Results posted to the registry on 19 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Roflumilast	371	309
Placebo	372	333

Primary outcome: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)

Time frame: Change from baseline over 24 weeks of treatment. Least squares mean (Standard Error). Unit: mL

Measure	Roflumilast n = 365	Placebo n = 364
Value	65 (12)	-16 (12)

Roflumilast vs Placebo: Mean Difference (Net): 80 (95% CI 51 to 110), p <0.0001, ANCOVA

Population analysed: ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks treatment period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Roflumilast	22 of 374 (5.9%)	106 of 374 (28.3%)	Not reported
Placebo	21 of 369 (5.7%)	76 of 369 (20.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19716961Fabbri 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. doi: 10.1016/S0140-6736(09)61252-6.
Derived from this study: PubMed 20102307Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca AstraZeneca study director

AstraZeneca

103 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Roflumilast in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 103 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in Spain, United Kingdom, Germany, France, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) (time frame: Change from baseline over 24 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00424268, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.