The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)
NCT ID: NCT00108823
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
550 participants
INTERVENTIONAL
2004-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Roflumilast
Eligibility Criteria
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Inclusion Criteria
* Patients with a history of chronic obstructive pulmonary disease for at least 12 months as defined by the GOLD (Global Initiative on Obstructive Lung Diseases) criteria (2003)
* Age ≥ 40 years
* FEV1/FVC ratio (post-bronchodilator) ≤ 70%
* FEV1 (post-bronchodilator) ≤ 65% of predicted
* FRC (post-bronchodilator) ≤ 120% of predicted
* Clinically stable COPD within 4 weeks prior to baseline visit (B0).
* Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit (B0) or a willingness to have a chest x-ray performed at visit (B0).
Exclusion Criteria
* Non smoker, current smoker or ex-smoker (smoking cessation at least one year ago) with a smoking history of \< 10 pack years
* Suffering from any concomitant disease that might interfere with study procedures or evaluation
* Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit (B0)
* Diagnosis of asthma and/or other relevant lung disease (e.g. history of bronchiectasis, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease \[e.g. fibrosis, silicosis, sarcoidosis\], and active tuberculosis)
* Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 2 months preceding the baseline visit (B0).
* Known alpha-1-antitrypsin deficiency
* Need for long term oxygen therapy defined as ≥ 15 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
* Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start
* Clinically significant cardiopulmonary abnormalities (diagnosed clinically or by x-ray/ECG) that are not related to COPD and that require further evaluation
* Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
* The female patient is of childbearing potential and is not using and is not willing to continue to use a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless she is surgically sterilized/hysterectomized or post-menopausal \> 1 year or any other criteria considered sufficiently reliable by the investigator in individual cases
* Participation in another study (use of investigational product) within 30 days preceding the baseline visit (B0) or re-entry of patients already enrolled in this trial
* Suspected inability or unwillingness to comply with study procedures
* Alcohol or drug abuse
* Inability to follow study procedures due to, for example, language problems or psychological disorders
* Use of prohibited drugs
* Suspected hypersensitivity to the study medication and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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ALTANA Pharma
Cities in California, California, United States
ALTANA Pharma
Cities in Colorado, Colorado, United States
ALTANA Pharma
Cities in Florida, Florida, United States
ALTANA Pharma
Cities in Missouri, Missouri, United States
ALTANA Pharma
Cities in New Mexico, New Mexico, United States
ALTANA Pharma
Cities in New York, New York, United States
ALTANA Pharma
Cities in Oregeon, Oregon, United States
ALTANA Pharma
Cities in South Carolina, South Carolina, United States
ALTANA Pharma
Cities in Texas, Texas, United States
ALTANA Pharma
Cities in Washington, Washington, United States
ALTANA Pharma
Cities in Canada, , Canada
ALTANA Pharma
Cities in France, , France
ALTANA Pharma
Cities in Poland, , Poland
ALTANA Pharma
Cities in South Africa, , South Africa
ALTANA Pharma
Cities in Spain, , Spain
ALTANA Pharma
Cities in the United Kingdom, , United Kingdom
Countries
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Related Links
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BY217-M2-121-RDS-2008-12-23.pdf
Other Identifiers
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BY217/M2-121
Identifier Type: -
Identifier Source: org_study_id