Chronic Obstructive Pulmonary DiseasePhase 3NCT00062582
Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)
A Phase 3 study testing Roflumilast in people with Chronic Obstructive Pulmonary Disease and COPD, run by AstraZeneca at 37 sites in 6 countries.
Trial summary
The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- Roflumilast
- How many people
- 1,000 participants
- Where
- 37 sitesin 6 countries
- Study dates
- Jun 2003to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease)
- Currently stable COPD with no change in COPD treatment in the prior 4 weeks
Main Exclusion Criteria:
- Clinical diagnosis of asthma
- Poorly controlled COPD
- Regular need for daily oxygen therapy
Trial locations and contacts
37 sites in 6 countries.
37 sites in 6 countries
United States32 sites
ALTANA Pharma
Cities in Alabama, Alabama
ALTANA Pharma
Cities in Arizona, Arizona
ALTANA Pharma
Cities in California, California
ATLANA Pharma
Cities in Colorado, Colorado
ALTANA Pharma
Cities in Conneticut, Connecticut
ALTANA Pharma
Cities in Delaware, Delaware
ALTANA Pharma
Cities in Florida, Florida
ALTANA Pharma
Cities in Georgia, Georgia
ALTANA Pharma
Cities in Idaho, Idaho
ALTANA Pharma
Cities in Indiana, Indiana
ALTANA Pharma
Cities in Iowa, Iowa
ALTANA Pharma
Cities in Kansas, Kansas
ALTANA Pharma
Cities in Kentucky, Kentucky
ALTANA Pharma
Cities in Louisiana, Louisiana
ALTANA Pharma
Cities in Maryland, Maryland
ALTANA Pharma
Cities in Michigan, Michigan
ALTANA Pharma
Cities in Missouri, Missouri
ALTANA Pharma
Cities in Nebraska, Nebraska
ALTANA Pharma
Cities in Nevada, Nevada
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 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 Texas, Texas
ALTANA Pharma
Cities in Utah, Utah
ALTANA Pharma
Cities in Virginia, Virginia
ALTANA Pharma
Cities in Washington, Washington
ALTANA Pharma
Cities in West Virginia, West Virginia
About this study
Official title: A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with 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.
pulmonary function.
Secondary outcomes (5)
exacerbation rate
quality of life
symptoms
use of rescue medication
safety and tolerability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2003 (estimated)
- Study startJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,000 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
- NCT00062582
- Sponsor's protocol ID
- BY217/M2-110
- Status last verified
- Sep 2016
- First submitted
- 9 Jun 2003
- Last updated
- 23 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00062582
- Acronym / sponsor ID
- BY217/M2-110
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Keywords
- Roflumilast, Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- First posted
- 10 Jun 2003 (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 aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 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
pulmonary function.
5 secondary outcomes
exacerbation rate
quality of life
symptoms
use of rescue medication
safety and tolerability.
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 23 Nov 2016.
- BY217-M2-110-RDS-2006-07-27.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
37 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 37 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 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Argentina, Canada, Colombia, Mexico 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?
pulmonary function.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2016.