Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00297102

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

A Phase 3 study testing Roflumilast in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 179 sites in 11 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 investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 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: 1,523 participants
Where: 179 sitesin 11 countries
Study dates: Feb 2006to Sep 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:

COPD patients having at least one exacerbation within last year
FEV1/FVC ratio (post-bronchodilator) ≤ 70%
FEV1 (post-bronchodilator) ≤ 50% of predicted

Main Exclusion Criteria:

COPD exacerbation not resolved at first baseline visit
Diagnosis of asthma and/or other relevant lung disease

Trial locations and contacts

179 sites in 11 countries.

Country

City, postcode or hospital

179 sites in 11 countries

United States47 sites

Altana Pharma/Nycomed Investigational Site
Atlanta, Georgia, 30309
Altana Pharma/Nycomed Investigational Site
Austin, Texas, 78750
Altana Pharma/Nycomed Investigational Site
Baltimore, Maryland, 21224
Altana Pharma/Nycomed Investigational Site
Bangor, Maine, 04401
Altana Pharma/Nycomed Investigational Site
Bay Pines, Florida, 33708
Altana Pharma/Nycomed Investigational Site
Bellingham, Washington, 98225
Altana Pharma/Nycomed Investigational Site
Billings, Montana, 59102
Altana Pharma/Nycomed Investigational Site
Charlottesville, VA, Virginia, 22908
Altana Pharma/Nycomed Investigational Site
Cherry Hill, New Jersey, 08003
Altana Pharma/Nycomed Investigational Site
Chesterfield, Missouri, 63017
Altana Pharma/Nycomed Investigational Site
Cincinnati, Ohio, 45241
Altana Pharma/Nycomed Investigational Site
Columbus, Ohio, 43215
Altana Pharma/Nycomed Investigational Site
Cranston, Rhode Island, 02920
Altana Pharma/Nycomed Investigational Site
Dallas, Texas, 75231
Altana Pharma/Nycomed Investigational Site
East Providence, Rhode Island, 02914
Altana Pharma/Nycomed Investigational Site
Edina, Minnesota, 55435
Altana Pharma/Nycomed Investigational Site
Fullerton, California, 92385
Altana Pharma/Nycomed Investigational Site
Hines, Illinois, 60141
Altana Pharma/Nycomed Investigational Site
Lake Oswego, Oregon, 97035
Altana Pharma/Nycomed Investigational Site
Lebanon, Kentucky, 40291
Altana Pharma/Nycomed Investigational Site
Lincoln, Nebraska, 68510
Altana Pharma/Nycomed Investigational Site
Los Angeles, California, 90025
Altana Pharma/Nycomed Investigational Site
Los Angeles, California, 90048
Altana Pharma/Nycomed Investigational Site
Marietta, Georgia, 30060
Altana Pharma/Nycomed Investigational Site
Marietta, Wisconsin, 53717
Altana Pharma/Nycomed Investigational Site
Metairie, Louisiana, 70006
Altana Pharma/Nycomed Investigational Site
Miami, Florida, 33176
Altana Pharma/Nycomed Investigational Site
Minneapolis, Minnesota, 55407
Altana Pharma/Nycomed Investigational Site
Missoula, Montana, 59804
Altana Pharma/Nycomed Investigational Site
New Orleans, Louisiana, 70112
Altana Pharma/Nycomed Investigational Site
New York, New York, 10029
Altana Pharma/Nycomed Investigational Site
North Dartmouth, Massachusetts, 02777
Altana Pharma/Nycomed Investigational Site
Omaha, Nebraska, 68114
Altana Pharma/Nycomed Investigational Site
Palmdale, California, 93551
Altana Pharma/Nycomed Investigational Site
Panama City, Florida, 32405
Altana Pharma/Nycomed Investigational Site
Philadelphia, Pennsylvania, 19140
Altana Pharma/Nycomed Investigational Site
Rancho Mirage, California, 92270
Altana Pharma/Nycomed Investigational Site
Reno, Nevada, 89502
Altana Pharma/Nycomed Investigational Site
San Diego, California, 92120
Altana Pharma/Nycomed Investigational Site
Slidell, Louisiana, 70461
Altana Pharma/Nycomed Investigational Site
South Bend, Indiana, 46617
Altana Pharma/Nycomed Investigational Site
Springfield, New Jersey, 07081
Altana Pharma/Nycomed Investigational Site
St Louis, Missouri, 63117
Altana Pharma/Nycomed Investigational Site
Sunset, Louisiana, 70584
Altana Pharma/Nycomed Investigational Site
Toledo, Ohio, 43614
Altana Pharma/Nycomed Investigational Site
Winston-Salem, North Carolina, 27103
Altana Pharma/Nycomed Investigational Site
Youngstown, Ohio, 44501

Other trials in United States

United Kingdom30 sites

Altana Pharma/Nycomed Investigational Site
Baillieston, Glasgow, G69 7AD
Altana Pharma/Nycomed Investigational Site
Bangor, Northern Ireland, BT19 1PP
Altana Pharma/Nycomed Investigational Site
Bath, BA1 2SR
Altana Pharma/Nycomed Investigational Site
Bath, Avon, BA2 3HT
Altana Pharma/Nycomed Investigational Site
Belfast, BT4 1NT
Altana Pharma/Nycomed Investigational Site
Birmingham, B9 5SS
Altana Pharma/Nycomed Investigational Site
Chesterfield, S40 4TF
Altana Pharma/Nycomed Investigational Site
Co. Antrim, BT38 8TP
Altana Pharma/Nycomed Investigational Site
Cottingham, E York, HU16 5JQ
Altana Pharma/Nycomed Investigational Site
County Antrim, BT37 9QN
Altana Pharma/Nycomed Investigational Site
Downpatrick, Northern Ireland, BT30 6HY
Altana Pharma/Nycomed Investigational Site
East Sussex, TN39 5HE
Altana Pharma/Nycomed Investigational Site
East Sussex, TN40 1JJ
Altana Pharma/Nycomed Investigational Site
Fife, KY12 8SJ
Altana Pharma/Nycomed Investigational Site
Glasgow, G45 9AW
Altana Pharma/Nycomed Investigational Site
Glasgow, G46 8NY
Altana Pharma/Nycomed Investigational Site
Glengormley Newtownabbey, BT36 5EQ
Altana Pharma/Nycomed Investigational Site
Harrow, HA3 7LT
Altana Pharma/Nycomed Investigational Site
Kent, CT5 1BZ
Altana Pharma/Nycomed Investigational Site
Liverpool, L9 7AL
Altana Pharma/Nycomed Investigational Site
Nottingham, NG5 1PB
Altana Pharma/Nycomed Investigational Site
Nottingham, NG7 2UH
Altana Pharma/Nycomed Investigational Site
Randalstown, BT41 3AE
Altana Pharma/Nycomed Investigational Site
Royal Leamington Spa, CV324RA
Altana Pharma/Nycomed Investigational Site
Sheffield, S39DA
Altana Pharma/Nycomed Investigational Site
Solihull, B91 2JL
Altana Pharma/Nycomed Investigational Site
Southampton, SO16 6YD
Altana Pharma/Nycomed Investigational Site
Southdown, Bath, BA2 1NH
Altana Pharma/Nycomed Investigational Site
Sunbury on Thames, Middlesex, TW16 6RH
Altana Pharma/Nycomed Investigational Site
Vale of Glamorgan, CF64 2XX

Other trials in United Kingdom

France26 sites

Altana Pharma/Nycomed Investigational Site
Beuvry, 62660
Altana Pharma/Nycomed Investigational Site
Chauny, 2303
Altana Pharma/Nycomed Investigational Site
Clermont-Ferrand Cedex1, 63003
Altana Pharma/Nycomed Investigational Site
Ferolles-Attily, 77150
Altana Pharma/Nycomed Investigational Site
Grasse, 6130
Altana Pharma/Nycomed Investigational Site
La Teste-de-Buch, 33260
Altana Pharma/Nycomed Investigational Site
Lens, 62307
Altana Pharma/Nycomed Investigational Site
Libourne, 33500
Altana Pharma/Nycomed Investigational Site
Lille, 59020
Altana Pharma/Nycomed Investigational Site
Lyon, 69003
Altana Pharma/Nycomed Investigational Site
Marcq-en-Barœul, 59700
Altana Pharma/Nycomed Investigational Site
Martigues, 13695
Altana Pharma/Nycomed Investigational Site
Metz, 57000
Altana Pharma/Nycomed Investigational Site
Montigny-lès-Metz, 57950
Altana Pharma/Nycomed Investigational Site
Montpellier, 34070
Altana Pharma/Nycomed Investigational Site
Montpellier, 34295
Altana Pharma/Nycomed Investigational Site
Nice, 6000
Altana Pharma/Nycomed Investigational Site
Nîmes, 30900
Altana Pharma/Nycomed Investigational Site
Ollioules, 83190
Altana Pharma/Nycomed Investigational Site
Paris, 75877
Altana Pharma/Nycomed Investigational Site
Perpignan, 66046
Altana Pharma/Nycomed Investigational Site
Saint-Etienne, 42000
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
Altana Pharma/Nycomed Investigational Site
Vieux-Condé, 59690

Other trials in France

Russia18 sites

Altana Pharma/Nycomed Investigational Site
Moscow, 10100
Altana Pharma/Nycomed Investigational Site
Moscow, 105077
Altana Pharma/Nycomed Investigational Site
Moscow, 105229
Altana Pharma/Nycomed Investigational Site
Moscow, 109240
Altana Pharma/Nycomed Investigational Site
Moscow, 111020
Altana Pharma/Nycomed Investigational Site
Moscow, 115280
Altana Pharma/Nycomed Investigational Site
Moscow, 115446
Altana Pharma/Nycomed Investigational Site
Moscow, 117049
Altana Pharma/Nycomed Investigational Site
Moscow, 118089
Altana Pharma/Nycomed Investigational Site
Moscow, 121356
Altana Pharma/Nycomed Investigational Site
Moscow, 123182
Altana Pharma/Nycomed Investigational Site
Moscow, 129110
Altana Pharma/Nycomed Investigational Site
Moscow, 143405
Altana Pharma/Nycomed Investigational Site
Saint Petersburg, 193015
Altana Pharma/Nycomed Investigational Site
Saint Petersburg, 194044
Altana Pharma/Nycomed Investigational Site
Saint Petersburg, 194100
Altana Pharma/Nycomed Investigational Site
Saint Petersburg, 194354
Altana Pharma/Nycomed Investigational Site
Saint Petersburg, 196211

Other trials in Russia

Brazil15 sites

Altana Pharma/Nycomed Investigational Site
Belo Horizonte - MG CEP, 30130100
Altana Pharma/Nycomed Investigational Site
Botucatu - SP CEP, 16618000
Altana Pharma/Nycomed Investigational Site
Curitiba-PR, 80060900
Altana Pharma/Nycomed Investigational Site
Florianópolis-SC, 88040970
Altana Pharma/Nycomed Investigational Site
Juiz de Fora-MG, 36036110
Altana Pharma/Nycomed Investigational Site
Porto Alegre, 90035074
Altana Pharma/Nycomed Investigational Site
Porto Alegre-RS, 90035003
Altana Pharma/Nycomed Investigational Site
Porto Alegre-RS, 90610000
Altana Pharma/Nycomed Investigational Site
Quadra 605 Brasilia - DF
Altana Pharma/Nycomed Investigational Site
Recife - PE
Altana Pharma/Nycomed Investigational Site
Rio de Janeiro-RJ, 21941590
Altana Pharma/Nycomed Investigational Site
Santo André-SP, 9060650
Altana Pharma/Nycomed Investigational Site
São Paulo-SP, 1221020
Altana Pharma/Nycomed Investigational Site
São Paulo-SP, 4023062
Altana Pharma/Nycomed Investigational Site
São Paulo-SP, 5403900

Other trials in Brazil

Hungary13 sites

Altana Pharma/Nycomed Investigational Site
Balassagyarmat, 2660
Altana Pharma/Nycomed Investigational Site
Budapest, 1134
Altana Pharma/Nycomed Investigational Site
Budapest, 1221
Altana Pharma/Nycomed Investigational Site
Budapest, 1475
Altana Pharma/Nycomed Investigational Site
Debrecen, 4043
Altana Pharma/Nycomed Investigational Site
Gyula, 5703
Altana Pharma/Nycomed Investigational Site
Komárom, 2900
Altana Pharma/Nycomed Investigational Site
Mosdós, 7257
Altana Pharma/Nycomed Investigational Site
Mosonmagyaróvár, 9200
Altana Pharma/Nycomed Investigational Site
Nyiregyháza, 4412
Altana Pharma/Nycomed Investigational Site
Pécs, 7621
Altana Pharma/Nycomed Investigational Site
Szeged, 6722
Altana Pharma/Nycomed Investigational Site
Tapolca, 8300

Other trials in Hungary

Australia11 sites

Altana Pharma/Nycomed Investigational Site
Adelaide South Australia, 5000
Altana Pharma/Nycomed Investigational Site
Box Hill, VIC 2138
Altana Pharma/Nycomed Investigational Site
Camperdown, NSW 2050
Altana Pharma/Nycomed Investigational Site
Clayton, VIC 3168
Altana Pharma/Nycomed Investigational Site
Concord, 2139
Altana Pharma/Nycomed Investigational Site
Geelong, VIC 3220
Altana Pharma/Nycomed Investigational Site
Kippa-Ring, QLD 4021
Altana Pharma/Nycomed Investigational Site
Nedlands, WA 6009
Altana Pharma/Nycomed Investigational Site
South Brisbane, QLD 4101
Altana Pharma/Nycomed Investigational Site
Toorak Gardens, SA 5056
Altana Pharma/Nycomed Investigational Site
Wayville, SA 5034

Other trials in Australia

Austria7 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
Innsbruck, 6020
Altana Pharma/Nycomed Investigational Site
Linz, 4040
Altana Pharma/Nycomed Investigational Site
Natters, 6161
Altana Pharma/Nycomed Investigational Site
Spittal an der Drau, 9800

Other trials in Austria

Germany6 sites

Altana Pharma/Nycomed Investigational Site
Deggendorf, 94469
Altana Pharma/Nycomed Investigational Site
Fulda, 36039
Altana Pharma/Nycomed Investigational Site
Kassel, 34121
Altana Pharma/Nycomed Investigational Site
Lübeck, 23552
Altana Pharma/Nycomed Investigational Site
Marburg, 35037
Altana Pharma/Nycomed Investigational Site
Schwetzingen, 68723

Other trials in Germany

Romania5 sites

Altana Pharma/Nycomed Investigational Site
Bucharest, 11025
Altana Pharma/Nycomed Investigational Site
Bucharest, 20125
Altana Pharma/Nycomed Investigational Site
Bucharest, 21659
Altana Pharma/Nycomed Investigational Site
Bucharest, 30303
Altana Pharma/Nycomed Investigational Site
Bucharest, 50159

Other trials in Romania

New Zealand1 site

Altana Pharma/Nycomed Investigational Site
Tauranga, 3001

Other trials in New Zealand

About this study

Official title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Roflumilast, Placebo
Keywords: Roflumilast, 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 mcg, once daily, oral administration in the morning
PlaceboDrug
once daily

Study groups in NCT00297102
Study group	Role	What they receive
Roflumilast	Active comparator	500 mcg, once daily, oral administration in the morning Receives: Drug: Roflumilast
Placebo	Placebo comparator	once daily 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 52 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: 52 weeks treatment period

Secondary outcomes (4)

Post-bronchodilator FEV1 [L]
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
Measured: Change from baseline over 52 weeks of treatment
Time to Mortality Due to Any Reason
Measured: 52 weeks treatment period
Natural Log-transformed C-reactive Protein (CRP)
Mean change from baseline to the last post randomization measurement in natural log-transformed CRP
Measured: Change from baseline to last post randomization measurement (52 weeks)
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
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 52 weeks of treatment

Timeline

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

Feb 2006Sep 2008

First posted28 Feb 2006 (estimated)
Study startFeb 2006
Primary completionJul 2008
Study completionSep 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 (5)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: 1,523 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00297102
Sponsor's protocol ID: BY217/M2-124
Status last verified: Sep 2016
First submitted: 27 Feb 2006
Last updated: 16 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1.
PubMed 19716960
Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
PubMed 28419462
Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.
PubMed 24120253
Wedzicha JA, Rabe KF, Martinez FJ, Bredenbroker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489.
PubMed 23117188
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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COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study
ClinicalTrials.gov ID: NCT00297102
Acronym / sponsor ID: BY217/M2-124
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Roflumilast, COPD, Chronic obstructive pulmonary disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,523 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Jul 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 28 Feb 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.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

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: Roflumilast500 mcg, once daily, oral administration in the morning
Placebo	Placebo comparator	Drug: Placeboonce daily

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 mcg, 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 52 weeks of treatment
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]
COPD Exacerbation Rate (Moderate or Severe)
Time frame: 52 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].

4 secondary outcomes

Post-bronchodilator FEV1 [L]
Time frame: Change from baseline over 52 weeks of treatment
Time to Mortality Due to Any Reason
Time frame: 52 weeks treatment period
Natural Log-transformed C-reactive Protein (CRP)
Time frame: Change from baseline to last post randomization measurement (52 weeks)
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
Time frame: Change from baseline over 52 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	765	502
Placebo	758	525

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

Time frame: Change from baseline over 52 weeks of treatment. Least squares mean (Standard Error). Unit: mL

Measure	Roflumilast n = 745	Placebo n = 745
Value	46 (8)	8 (8)

Roflumilast vs Placebo: Mean Difference (Net): 39 (95% CI 18 to 60), p = 0.0003, ANCOVA

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

Primary outcome: COPD Exacerbation Rate (Moderate or Severe)

Time frame: 52 weeks treatment period. Mean (95% Confidence Interval). Unit: exacerbations per patient per year

Measure	Roflumilast n = 765	Placebo n = 758
Value	1.077 (0.960 to 1.207)	1.266 (1.141 to 1.404)

Roflumilast vs Placebo: Rate ratio: 0.851 (95% CI 0.737 to 0.982), p = 0.0278, Poisson regression

Population analysed: ITT analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks treatment period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Roflumilast	144 of 769 (18.7%)	232 of 769 (30.2%)	Not reported
Placebo	153 of 755 (20.3%)	136 of 755 (18%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19716960Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1.
Derived from this study: PubMed 28419462Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
Derived from this study: PubMed 24120253Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.
Derived from this study: PubMed 23117188Wedzicha JA, Rabe KF, Martinez FJ, Bredenbroker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489.
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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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

179 sites in 11 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 179 sites in 11 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 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 179 sites in United States, United Kingdom, France, Russia, Brazil and 6 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 52 weeks of treatment). The study lists 2 primary outcomes in all. 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 NCT00297102, which also lists 5 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 16 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.