COPDPhase 3NCT00242320
Efficacy and Safety of Oral Roflumilast Taken Once Daily in Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (BY217/M2-119)
A Phase 3 study testing Roflumilast in people with COPD, run by AstraZeneca at 32 sites in 5 countries.
Trial summary
The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- 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
- 551 participants
- Where
- 32 sitesin 5 countries
- Study dates
- Aug 2005to Aug 2007
- 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:
- Written informed consent
- Patients with a history of chronic obstructive pulmonary disease (COPD) as defined by the GOLD criteria (2003)
- FEV1/FVC ratio (post bronchodilator) smaller or equal 70%
- FEV1 (post bronchodilator) 30-80% of predicted
- Fixed airway obstruction
- Current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 10 pack years
- Clinically stable COPD within 4 weeks prior to baseline visit
- Availability of a chest x-ray
Main Exclusion Criteria:
- COPD exacerbation indicated by a treatment with systemic glucocorticosteroids
- Lower respiratory tract infection
- Diagnosis of asthma
- Known alpha-1-antitrypsin deficiency
- Need for long term oxygen therapy defined as longer or equal 16 hours/day
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
- Known infection with HIV, active hepatitis and/or liver insufficiency (according to the Child Pugh score A or worse)
- Diagnosis or history of cancer
- Clinically significant cardiopulmonary abnormalities
- Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
- Female patients of childbearing potential, not using reliable method of contraception for the entire study duration, post-menopausal > 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases
- Participation in another study (use of investigational product) within 30 days preceding the baseline visit or re-entry of patients already enroled in this trial
- Alcohol or drug abuse
- Inability to follow the study procedures due to e.g., language problems, physiological disorders
- Use of not allowed drugs
- Suspected hypersensitivity to the study medication or rescue medication
Trial locations and contacts
32 sites in 5 countries.
32 sites in 5 countries
South Korea15 sites
Altana Pharma/Nycomed
Anvang-Si, Gveonggi-Do, 431-070
Altana Pharma/Nycomed
Gangwon-do, 220-701
Altana Pharma/Nycomed
Gangwon-Do, 220-711
Altana Pharma/Nycomed
Gwangju, 501-757
Altana Pharma/Nycomed
Gyeonggi-do, 420-767
Altana Pharma/Nycomed
Jiniu-Si. Gveongsangnam-Do, 660-702
Altana Pharma/Nycomed
Jungbuk, 361-711
Altana Pharma/Nycomed
Seoul, 135-720
Altana Pharma/Nycomed
Seoul, 136-705
Altana Pharma/Nycomed
Seoul, 137-701
Altana Pharma/Nycomed
Seoul, 138-736
Altana Pharma/Nycomed
Seoul, 140-757
Altana Pharma/Nycomed
Seoul, 158-710
Altana Pharma/Nycomed
Uijongbu-city, Gveonggi-Do, 480-130
Altana Pharma/Nycomed
Ulsan, 682-060
Malaysia6 sites
Altana Pharma/Nycomed
Jalan Rasah, Seremban, 70300
Altana Pharma/Nycomed
Kota Bharu / Kelantan, 16150
Altana Pharma/Nycomed
Kota Kinabalu, Sabah, 88586
Altana Pharma/Nycomed
Kuala Lumpur, 50590
Altana Pharma/Nycomed
Kuala Lumpur, 56000
Altana Pharma/Nycomed
Kuala Lumpur, 59100
Philippines5 sites
Altana Pharma/Nycomed
Manila, 1000
Altana Pharma/Nycomed
Quezon City, 1100
Altana Pharma/Nycomed
Quezon City, 1102
Altana Pharma/Nycomed
Quezon City, 850
Altana Pharma/Nycomed
Quezon City, 870
Taiwan4 sites
Altana Pharma/Nycomed
Kaohsiung City, 886-807
Altana Pharma/Nycomed
Taipei, 886-114
Altana Pharma/Nycomed
Taipei
Altana Pharma/Nycomed
Tau-Yuan, 886-333
Hong Kong2 sites
Altana Pharma/Nycomed
Hong Kong, 852
Altana Pharma/Nycomed
Shatin, NT, Hong Kong
About this study
Official title: The JADE Study: A 12-week, Double-blind, Randomized Study to Investigate the Effect of 500 mcg Roflumilast Tablets Once Daily Versus Placebo on Pulmonary Function in Patients With Chronic Obstructive Pulmonary Disease
The aim of the study is to compare the effect of roflumilast on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.
- Conditions
- COPD
- Being tested
- Roflumilast, Placebo
- Keywords
- COPD, chronic obstructive pulmonary disease, Roflumilast
- 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
to investigate the effect of 500 µg Roflumilast tablets once daily versus placebo
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Roflumilast 500 µg Receives: Drug: Roflumilast |
| 2 | Placebo comparator | Placebo Receives: Drug: Roflumilast; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change from randomization to endpoint in lung function (post bronchodilator)
Measured: 12 weeks
Secondary outcomes (5)
mean change from randomization to endpoint in pre and post bronchodilator spirometric parameters
Measured: 12 weeks
exacerbation rate
Measured: 12 weeks
adverse events
Measured: 12 weeks
changes in laboratory values
Measured: 12 weeks
changes in vital signs
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startAug 2005
- Primary completionMay 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 551 participants (actual)
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
- NCT00242320
- Sponsor's protocol ID
- BY217/M2-119
- Status last verified
- Sep 2016
- First submitted
- 19 Oct 2005
- Last updated
- 2 Dec 2016
- Results posted
- No
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
- The JADE Study: A 12-week, Double-blind, Randomized Study to Investigate the Effect of 500 mcg Roflumilast Tablets Once Daily Versus Placebo on Pulmonary Function in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00242320
- Acronym / sponsor ID
- BY217/M2-119
- Conditions
- COPD
- Keywords
- COPD, chronic obstructive pulmonary disease, Roflumilast
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- May 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 20 Oct 2005 (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 on lung function in patients with COPD. Roflumilast will be administered orally once daily in the morning at one dose level. The study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of roflumilast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: RoflumilastRoflumilast 500 µg |
| 2 | Placebo comparator | Drug: Roflumilast, Drug: PlaceboPlacebo |
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 |
|---|---|---|
| Roflumilastto investigate the effect of 500 µg Roflumilast tablets once daily versus placebo | Drug | 1, 2 |
| Placebo | Drug | 2 |
Primary outcome
mean change from randomization to endpoint in lung function (post bronchodilator)
Time frame: 12 weeks
5 secondary outcomes
mean change from randomization to endpoint in pre and post bronchodilator spirometric parameters
Time frame: 12 weeks
exacerbation rate
Time frame: 12 weeks
adverse events
Time frame: 12 weeks
changes in laboratory values
Time frame: 12 weeks
changes in vital signs
Time frame: 12 weeks
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.
- BY217-M2-119-RDS-2008-07-09.pdfLink provided by the sponsor.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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
32 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 COPD, run by AstraZeneca at 32 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 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 32 sites in South Korea, Malaysia, Philippines, Taiwan, Hong Kong. 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?
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?
mean change from randomization to endpoint in lung function (post bronchodilator) (time frame: 12 weeks). 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 2 Dec 2016.