Status:
COMPLETED
The HERO-study: Effects of Roflumilast in Patients With COPD (Chronic Obstructive Pulmonary Disease) (BY217/M2-121)
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease, COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to study the effects of roflumilast on lung function parameters indicative of hyperinflation in patients with COPD.
Eligibility Criteria
Inclusion
- Main
- Written informed consent
- 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).
- Main
Exclusion
- COPD exacerbation indicated by a treatment with systemic glucocorticosteroids not stopped at least 4 weeks prior to the baseline visit (B0)
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT00108823
Start Date
October 1 2004
Last Update
October 26 2016
Active Locations (16)
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1
ALTANA Pharma
Cities in California, California, United States
2
ALTANA Pharma
Cities in Colorado, Colorado, United States
3
ALTANA Pharma
Cities in Florida, Florida, United States
4
ALTANA Pharma
Cities in Missouri, Missouri, United States