Chronic Obstructive Pulmonary DiseasePhase 3NCT00076089
OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
A Phase 3 study testing Roflumilast in people with Chronic Obstructive Pulmonary Disease and COPD, run by AstraZeneca at 40 sites in 6 countries.
Trial summary
The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD). 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
- How many people
- 1,100 participants
- Where
- 40 sitesin 6 countries
- Study dates
- Dec 2003to Dec 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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:
- FEV1/FVC ratio (post-bronchodilator) ≤70%
- FEV1 (post-bronchodilator) ≤50% of predicted
- Current smoker or ex-smoker
- Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline
- Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline
Main Exclusion Criteria:
- COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline
- Lower respiratory tract infection not resolved 4 weeks prior to baseline
- Diagnosis of asthma and/or other relevant lung disease
- Known alpha-1-antitrypsin deficiency
- Need for long-term oxygen therapy defined as ≥16 hours/day
Trial locations and contacts
40 sites in 6 countries.
40 sites in 6 countries
United States35 sites
ALTANA Pharma
Cities in Alabama, Alabama
ALTANA Pharma
Cities in Arizona, Arizona
ALTANA Pharma
Cities in Arkansas, Arkansas
ALTANA Pharma
Cities in California, California
ALTANA Pharma
Cities in Colorado, Colorado
ALTANA Pharma
Cities in Connecticut, Connecticut
ALTANA Pharma
Cities in Florida, Florida
ALTANA Pharma
Cities in Georgia, Georgia
ALTANA Pharma
Cities in Illionois, Illinois
ALTANA Pharma
Cities in Iowa, Iowa
ALTANA Pharma
Cities in Kentucky, Kentucky
ALTANA Pharma
Cities in Louisiana, Louisiana
ALTANA Pharma
Cities in Massachusetts, Massachusetts
ALTANA Pharma
Cities in Minnesota, Minnesota
ALTANA Pharma
Cities in Missouri, Missouri
ALTANA Pharma
Cities in Montana, Montana
ALTANA Pharma
Cities in Nebraska, Nebraska
ALTANA Pharma
Cities in Nevada, Nevada
ALTANA Pharma
Cities in New Hampshire, New Hampshire
ALTANA Pharma
Cities in New Jersey, New Jersey
ALTANA Pharma
Cities in New York, New York
ALTANA Pharma
Cities in North Carolina, North Carolina
ALTANA Pharma
Cities in Ohio, Ohio
ALTANA Pharma
Cities in Oklahoma, Oklahoma
ALTANA Pharma
Cities in Oregon, Oregon
ALTANA Pharma
Cities in Pennsylvania, Pennsylvania
ALTANA Pharma
Cities in Rhode Island, Rhode Island
ALTANA Pharma
Cities in South Carolina, South Carolina
ALTANA Pharma
Cities in Tennessee, Tennessee
ALTANA Pharma
Cities in Texas, Texas
ALTANA Pharma
Cities in Utah, Utah
ALTANA Pharma
Cities in Vermont, Vermont
ALTANA Pharma
Cities in Virginia, Virginia
ALTANA Pharma
Cities in West Virginia, West Virginia
ALTANA Pharma
Cities in Wisconsin, Wisconsin
About this study
Official title: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.
The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Being tested
- Roflumilast
- Keywords
- Roflumilast, Chronic obstructive pulmonary disease, COPD
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
Secondary outcomes (6)
pulmonary function variables
number of COPD exacerbations of different type and various subgroups
quality of life variables
patient diary variables
time to study withdrawal
safety.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2004 (estimated)
- Study startDec 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 1,100 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca AstraZeneca, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076089
- Sponsor's protocol ID
- BY217/M2-111
- Status last verified
- Sep 2016
- First submitted
- 13 Jan 2004
- Last updated
- 2 Dec 2016
- Results posted
- No
Publications
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 28419462Rennard SI, Calverley PM, Goehring UM, Bredenbroker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12(1):18. doi: 10.1186/1465-9921-12-18.
PubMed 21272339
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.
- ClinicalTrials.gov ID
- NCT00076089
- Acronym / sponsor ID
- BY217/M2-111
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Keywords
- Roflumilast, Chronic obstructive pulmonary disease, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 15 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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 |
|---|---|---|
| Roflumilast | Drug | – |
Primary outcome
change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
6 secondary outcomes
pulmonary function variables
number of COPD exacerbations of different type and various subgroups
quality of life variables
patient diary variables
time to study withdrawal
safety.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- 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 21272339Rennard SI, Calverley PM, Goehring UM, Bredenbroker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12(1):18. doi: 10.1186/1465-9921-12-18.
- BY217-M2-111-RDS-2008-12-23.pdfLink provided by the sponsor.
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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
40 sites in 6 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 and COPD, run by AstraZeneca at 40 sites in 6 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 2 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 40 sites in United States, Canada, France, Germany, Poland and 1 more country. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in FEV1 from baseline during the treatment period; number of COPD exacerbations.. 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 NCT00076089, 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 2 Dec 2016.