Chronic Obstructive Pulmonary Disease (COPD)Phase 3EOSNCT00313209

Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)

A Phase 3 study testing Roflumilast in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 134 sites in 10 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 on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. 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 (COPD)
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: 933 participants
Where: 134 sitesin 10 countries
Study dates: Apr 2006to Feb 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
FEV1/FVC ratio (post-bronchodilator) ≤ 70%
FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted

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

134 sites in 10 countries.

Country

City, postcode or hospital

134 sites in 10 countries

Canada26 sites

Altana Pharma/Nycomed Investigational Site
Ajax, Ontario, L1S 2J7
Altana Pharma/Nycomed Investigational Site
Halifax, N.S., B3H 3A7
Altana Pharma/Nycomed Investigational Site
Hamilton, L8N4A6
Altana Pharma/Nycomed Investigational Site
Hamilton, Ontario, L8N3Z5
Altana Pharma/Nycomed Investigational Site
Laval, H7V3Y7
Altana Pharma/Nycomed Investigational Site
London, N6A 5R9
Altana Pharma/Nycomed Investigational Site
Mirabel, J7J 2K8
Altana Pharma/Nycomed Investigational Site
Montreal, H2L 4M1
Altana Pharma/Nycomed Investigational Site
Montreal, H4J 1C5
Altana Pharma/Nycomed Investigational Site
Montreal, PQ, H2X2P4
Altana Pharma/Nycomed Investigational Site
New Market, on, L3Y 5G8
Altana Pharma/Nycomed Investigational Site
North Bay, P1B2H3
Altana Pharma/Nycomed Investigational Site
Ontario, L4C3Y1
Altana Pharma/Nycomed Investigational Site
Ottawa, K1Y 4G2
Altana Pharma/Nycomed Investigational Site
Québec, G8T 7A1
Altana Pharma/Nycomed Investigational Site
Regina, Saskatchewan, S4P 1Z7
Altana Pharma/Nycomed Investigational Site
Saint John, E2K2T8
Altana Pharma/Nycomed Investigational Site
Sainte-Foy, Quebec, G1V4G5
Altana Pharma/Nycomed Investigational Site
Saskatoon SK, S7N 0W8
Altana Pharma/Nycomed Investigational Site
Sherbrooke, PQ, J1H 5N4
Altana Pharma/Nycomed Investigational Site
Toronto, on, M5B 1W8
Altana Pharma/Nycomed Investigational Site
Toronto, on, M5T 3A9
Altana Pharma/Nycomed Investigational Site
Vancouver, BC, V6S 3J5
Altana Pharma/Nycomed Investigational Site
Windsor, N8X 3V6
Altana Pharma/Nycomed Investigational Site
Winnipeg MB, R2K 3S8
Altana Pharma/Nycomed Investigational Site
Woodstock, N4S 4G3

Other trials in Canada

France16 sites

Altana Pharma/Nycomed Investigational Site
Beausoleil, 6240
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
Grenoble, 38100
Altana Pharma/Nycomed Investigational Site
Lille, 59037
Altana Pharma/Nycomed Investigational Site
Lyon, 69003
Altana Pharma/Nycomed Investigational Site
Martigues, 13695
Altana Pharma/Nycomed Investigational Site
Montpellier, 34070
Altana Pharma/Nycomed Investigational Site
Nantes, 44000
Altana Pharma/Nycomed Investigational Site
Nice, 6000
Altana Pharma/Nycomed Investigational Site
Nice, 6002
Altana Pharma/Nycomed Investigational Site
Nîmes, 30900
Altana Pharma/Nycomed Investigational Site
Saint-Laurent-du-Var, 6700
Altana Pharma/Nycomed Investigational Site
Saint-Quentin, 2100
Altana Pharma/Nycomed Investigational Site
Trélazé, 49800

Other trials in France

Germany16 sites

Altana Pharma/Nycomed Investigational Site
Aschaffenburg, 63739
Altana Pharma/Nycomed Investigational Site
Bochum, 44787
Altana Pharma/Nycomed Investigational Site
Bonn, 53119
Altana Pharma/Nycomed Investigational Site
Cologne, 51069
Altana Pharma/Nycomed Investigational Site
Geesthacht, 21502
Altana Pharma/Nycomed Investigational Site
Gelnhausen, 63571
Altana Pharma/Nycomed Investigational Site
Großhansdorf, 22927
Altana Pharma/Nycomed Investigational Site
Hanover, 30167
Altana Pharma/Nycomed Investigational Site
Koblenz, 56068
Altana Pharma/Nycomed Investigational Site
Marburg, 35037
Altana Pharma/Nycomed Investigational Site
Saarbrücken, 66111
Altana Pharma/Nycomed Investigational Site
Schwetzingen, 68723
Altana Pharma/Nycomed Investigational Site
Sinsheim, 74889
Altana Pharma/Nycomed Investigational Site
Surwold, 26903
Altana Pharma/Nycomed Investigational Site
Witten, 58452
Altana Pharma/Nycomed Investigational Site
Würzburg, 97070

Other trials in Germany

United Kingdom16 sites

Altana Pharma/Nycomed Investigational Site
Belfast, BT14 6AB
Altana Pharma/Nycomed Investigational Site
Belfast, BT15 2GE
Altana Pharma/Nycomed Investigational Site
Belfast, BT7 1DA
Altana Pharma/Nycomed Investigational Site
Bexhill-on-Sea, East Sussex, TN40 1JJ
Altana Pharma/Nycomed Investigational Site
Bradford, BD157NJ
Altana Pharma/Nycomed Investigational Site
Bradford on Avon, Wiltshire, BA15 1DQ
Altana Pharma/Nycomed Investigational Site
Chesterfield Derbyshire, S40 4TF
Altana Pharma/Nycomed Investigational Site
Coleraine, BT52 1HS
Altana Pharma/Nycomed Investigational Site
Cookstown, BT80 8BG
Altana Pharma/Nycomed Investigational Site
East Sussex, TN39 5HE
Altana Pharma/Nycomed Investigational Site
Edinburgh, EH8 9AG
Altana Pharma/Nycomed Investigational Site
Glasgow, G3 8YJ
Altana Pharma/Nycomed Investigational Site
Hastings, TN34 3EY
Altana Pharma/Nycomed Investigational Site
Middlessex, HA6 2RN
Altana Pharma/Nycomed Investigational Site
Sunbury on Thames, Middlessex, TW16 6RH
Altana Pharma/Nycomed Investigational Site
Watford, WD25 0EA

Other trials in United Kingdom

Belgium14 sites

Altana Pharma/Nycomed Investigational Site
Arlon, 6700
Altana Pharma/Nycomed Investigational Site
Brussels, 1000
Altana Pharma/Nycomed Investigational Site
Brussels, 1040
Altana Pharma/Nycomed Investigational Site
Duffel, 2570
Altana Pharma/Nycomed Investigational Site
Genk, 3600
Altana Pharma/Nycomed Investigational Site
Gilly, 6060
Altana Pharma/Nycomed Investigational Site
Halen, 3545
Altana Pharma/Nycomed Investigational Site
Jette, 1090
Altana Pharma/Nycomed Investigational Site
Leuven, 3000
Altana Pharma/Nycomed Investigational Site
Liège, 4000
Altana Pharma/Nycomed Investigational Site
Malmedy, 4960
Altana Pharma/Nycomed Investigational Site
Montigny-le-Tilleul, 6110
Altana Pharma/Nycomed Investigational Site
Namur, 5000
Altana Pharma/Nycomed Investigational Site
Veurne, 8630

Other trials in Belgium

Italy14 sites

Altana Pharma/Nycomed Investigational Site
Bari, 70124
Altana Pharma/Nycomed Investigational Site
Bologna, 48138
Altana Pharma/Nycomed Investigational Site
Catania, 95125
Altana Pharma/Nycomed Investigational Site
Cisanello (PI), 56100
Altana Pharma/Nycomed Investigational Site
Genova, 16100
Altana Pharma/Nycomed Investigational Site
Livorno, 57124
Altana Pharma/Nycomed Investigational Site
Milan, 20153
Altana Pharma/Nycomed Investigational Site
Pordenone, 33170
Altana Pharma/Nycomed Investigational Site
Roma, 156
Altana Pharma/Nycomed Investigational Site
Saluzzo (CN), 12037
Altana Pharma/Nycomed Investigational Site
Torino, 10126
Altana Pharma/Nycomed Investigational Site
Tradate (VA), 21049
Altana Pharma/Nycomed Investigational Site
Verona, 30012
Altana Pharma/Nycomed Investigational Site
Vittorio Veneto (TV), 31029

Other trials in Italy

Spain14 sites

Altana Pharma/Nycomed Investigational Site
Alicante, 3550
Altana Pharma/Nycomed Investigational Site
Barcelona, 8017
Altana Pharma/Nycomed Investigational Site
Barcelona, 8023
Altana Pharma/Nycomed Investigational Site
Barcelona, 8025
Altana Pharma/Nycomed Investigational Site
Barcelona, 8222
Altana Pharma/Nycomed Investigational Site
Elche (Alicante), 3202
Altana Pharma/Nycomed Investigational Site
Fuentesnuevas, Ponferrada (León), 24411
Altana Pharma/Nycomed Investigational Site
Guadalajara, 19002
Altana Pharma/Nycomed Investigational Site
Laredo (Cantabria), 39770
Altana Pharma/Nycomed Investigational Site
Mataró, Barcelona, 8303
Altana Pharma/Nycomed Investigational Site
Petrer (Alicante), 3610
Altana Pharma/Nycomed Investigational Site
Sabadell, 8208
Altana Pharma/Nycomed Investigational Site
Tarrasa (Barcelona), 8221
Altana Pharma/Nycomed Investigational Site
Torrelavega (Cantabria), 39300

Other trials in Spain

Austria11 sites

Altana Pharma/Nycomed Investigational Site
Linz, 4020
Altana Pharma/Nycomed Investigational Site
Neusiedl/See, 7100
Altana Pharma/Nycomed Investigational Site
Perg, 4320
Altana Pharma/Nycomed Investigational Site
Salzburg, 5020
Altana Pharma/Nycomed Investigational Site
Sankt Pölten, 3100
Altana Pharma/Nycomed Investigational Site
Steyr, 4400
Altana Pharma/Nycomed Investigational Site
Vienna, 1030
Altana Pharma/Nycomed Investigational Site
Vienna, 1140
Altana Pharma/Nycomed Investigational Site
Vienna, 1150
Altana Pharma/Nycomed Investigational Site
Wiener Neustadt, 2700
Altana Pharma/Nycomed Investigational Site
Zwettl Stadt, 3910

Other trials in Austria

Netherlands6 sites

Altana Pharma/Nycomed Investigational Site
Alkmaar, 1815 JD
Altana Pharma/Nycomed Investigational Site
Almelo, 7609 PP
Altana Pharma/Nycomed Investigational Site
Eindhoven, 5623 EJ
Altana Pharma/Nycomed Investigational Site
Helmond, 5707 HA
Altana Pharma/Nycomed Investigational Site
Schiedam, 3116 BA
Altana Pharma/Nycomed Investigational Site
Zwolle, 8011 JW

Other trials in Netherlands

South Africa1 site

Altana Pharma/Nycomed Investigational Sites
Cape Town

Other trials in South Africa

About this study

Official title: Effect of Roflumilast in COPD Patients Treated With Salmeterol. A 24-week, Double-blind Study With 500 μg Roflumilast Once Daily Versus Placebo. The EOS Study

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Roflumilast, Placebo
Keywords: Roflumilast, Salmeterol, COPD, Chronic obstructive pulmonary disease
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 NCT00313209
Study group	Role	What they receive
Roflumilast	Active comparator	Roflumilast 500 µg underlying medication: salmeterol 50 μg, twice daily, inhaled Receives: Drug: Roflumilast
Placebo	Placebo comparator	Placebo underlying medication: salmeterol 50 μg, twice 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 (Mild, Moderate or Severe)
Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or 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 [ATS / 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.

Apr 2006Feb 2008

First posted12 Apr 2006 (estimated)
Study startApr 2006
Primary completionJul 2007
Study completionFeb 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 Disease (COPD)Studies 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: 933 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00313209
Sponsor's protocol ID: BY217/M2-127
Other IDs: 2005-005080-28, 2005
Acronym: EOS
Status last verified: Nov 2016
First submitted: 11 Apr 2006
Last updated: 14 Dec 2016
Results posted: Yes, on ClinicalTrials.gov

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

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia

All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 14 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 Salmeterol. A 24-week, Double-blind Study With 500 μg Roflumilast Once Daily Versus Placebo. The EOS Study
ClinicalTrials.gov ID: NCT00313209
Acronym / sponsor ID: EOS / BY217/M2-127
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Roflumilast, Salmeterol, COPD, Chronic obstructive pulmonary disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 933 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Jul 2007 (actual)
Study completion: Feb 2008 (actual)
First posted: 12 Apr 2006 (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: salmeterol 50 μg, twice daily, inhaled
Placebo	Placebo comparator	Drug: PlaceboPlacebo underlying medication: salmeterol 50 μg, twice 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 (Mild, 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	466	359
Placebo	467	385

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 = 456	Placebo n = 463
Value	39 (9)	-10 (9)

Roflumilast vs Placebo: Mean Difference (Net): 49 (95% CI 27 to 71), 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	36 of 466 (7.7%)	165 of 466 (35.4%)	Not reported
Placebo	42 of 467 (9%)	143 of 467 (30.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 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.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia

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

134 sites in 10 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 (COPD), run by AstraZeneca at 134 sites in 10 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 14 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 134 sites in Canada, France, Germany, United Kingdom, Belgium and 5 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 NCT00313209, 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 14 Dec 2016.