AsthmaPhase 3NCT00073177
Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)
A Phase 3 study testing Roflumilast in people with Asthma, run by AstraZeneca at 41 sites in 5 countries.
Trial summary
The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Roflumilast
- How many people
- 819 participants
- Where
- 41 sitesin 5 countries
- Study dates
- Nov 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Persistent bronchial asthma
- No change in asthma treatment within 4 weeks prior to visit 1
- Non-smoker or ex-smoker (for 12 months or longer)
Main Exclusion Criteria:
- Poorly controlled asthma or seasonal asthma
- History of lower airway infection four weeks prior to visit 1
- Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease
- Patients using > 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1
- Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection
- Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
- Patients with chronic heart failure
- Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol
- Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females
- Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study
Trial locations and contacts
41 sites in 5 countries.
41 sites in 5 countries
United States37 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 Florida, Florida
ALTANA Pharma
Cities in Georgia, Georgia
ALTANA Pharma
Cities in Idaho, Idaho
ALTANA Pharma
Cities in Illinois, Illinois
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 Minnesota, Minnesota
ALTANA Pharma
Cities in Mississippi, Mississippi
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 Jersey, New Jersey
ALTANA Pharma
Cities in New York, New York
ALTANA Pharma
Cities in North Carolina, North Carolina
ALTANA Pharma
Cities in North Dakota, North Dakota
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 Virginia, Virginia
ALTANA Pharma
Cities in Washington, Washington
ALTANA Pharma
Cities in Wisconsin, Wisconsin
ALTANA Pharma
Massachusetts, Massachusetts
About this study
Official title: A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 mcg or 500 mcg) Daily in Patients With Asthma
The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.
- Conditions
- Asthma
- Being tested
- Roflumilast
- Medical subject headings
- Asthma
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 lung function from baseline to final visit.
Secondary outcomes (6)
pulmonary function variables
diary variables
quality of life variables
time to first exacerbation
number of asthma exacerbations
safety.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2003 (estimated)
- Study startNov 2003
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 AsthmaStudies 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
- 819 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
- NCT00073177
- Sponsor's protocol ID
- BY217/M2-012
- Status last verified
- Sep 2016
- First submitted
- 17 Nov 2003
- Last updated
- 25 Oct 2016
- Results posted
- No
Publications
Chervinsky P, Meltzer EO, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Safety findings from a pooled analysis of ten clinical studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S28-34. doi: 10.1016/j.pupt.2015.11.003. Epub 2015 Nov 22.
PubMed 26612545Meltzer EO, Chervinsky P, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Efficacy findings in placebo-controlled studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S20-7. doi: 10.1016/j.pupt.2015.10.006. Epub 2015 Oct 21.
PubMed 26498386
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 mcg or 500 mcg) Daily in Patients With Asthma
- ClinicalTrials.gov ID
- NCT00073177
- Acronym / sponsor ID
- BY217/M2-012
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 819 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- First posted
- 19 Nov 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 effects of oral roflumilast with placebo on lung function in patients with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- 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 lung function from baseline to final visit.
6 secondary outcomes
pulmonary function variables
diary variables
quality of life variables
time to first exacerbation
number of asthma exacerbations
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 25 Oct 2016.
- Derived from this study: PubMed 26612545Chervinsky P, Meltzer EO, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Safety findings from a pooled analysis of ten clinical studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S28-34. doi: 10.1016/j.pupt.2015.11.003. Epub 2015 Nov 22.
- Derived from this study: PubMed 26498386Meltzer EO, Chervinsky P, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Efficacy findings in placebo-controlled studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S20-7. doi: 10.1016/j.pupt.2015.10.006. Epub 2015 Oct 21.
- BY217-M2-012-RDS-2007-01-02.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
41 sites in 5 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 Asthma, run by AstraZeneca at 41 sites in 5 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 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Argentina, Colombia, Mexico, Peru. 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 lung function from baseline to final visit.. 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 NCT00073177, 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 25 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.