Chronic Obstructive Pulmonary Disease
Conditions
Keywords
roflumilast
Brief summary
To evaluate the safety and pharmacokinetics of different dose roflumilast in China COPD patient.
Detailed description
Roflumilast is a product which has been approved for the treatment of severe chronic obstructive lung disease (COPD) and its approved dose is 500μg once daily. This study is primarily designed to see whether alternation in this dose can improve tolerability of Roflumilast in COPD patients. Therefore one in three patients will start roflumilast therapy at a lower dose of 250μg/375μg once daily, another one in three will only take the 500μg tablet every day (and one placebo every day). Furthermore, the study will evaluate the safety and pharmacokinetics of different dose roflumilast in China COPD patient. Lastly, the study will investigate what the body does to roflumilast. Patients with a history of COPD for at least last 12 months and a former smoker or current smoker with history of at least 10 pack years will be invited to participate. The Randomization visit is considered the Baseline visit and for participants that discontinue the Main Period and continue into the Down-Titration Period Day 1 of Down Titration is considered BaselineDT.
Interventions
DRUGRoflumilast
DRUGPlacebo
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is male or female and aged 40 or olderThe BMI≥ 19.0 kg/m2; 2. The patient with severe to very severe COPD as difine by the 2015 Gold strategy .(postbronchodilator ≤0.7,，and a postbronchodilator FEV1≤50% predicted); 3. Has a history of chronic obstructive pulmonary disease (COPD) (according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2015) for at least 12 months prior to Screening (Visit V0), At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 0); 4. Must be a former smoker (defined as smoking cessation at least one year ago) or current smoker both with a smoking history of at least 10 pack years; 5. Women of childbearing age must take reliable contraceptive measures 6. Signed informed consent
Exclusion criteria
1. Severe or very severe COPD exacerbations is still exist in screen visit(V0); 2. Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0; 3. History of asthma diagnosis in patients \< 40 years of age or relevant lung disease other than COPD; 4. relevant lung disease other than COPD,as: Bronchiectasis, Cystic fibrosis, capillary bronchitis, lung resection, lung cancer, interstitial lung disease and active tuberculosis 5. Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0 6. Known alpha-1-antitrypsin deficiency; 7. Clinically significant abnormal Laboratory examination,may due to one Undiagnosed disease 8. The patient with severe Mental or neurological disease; 9. Has a history with Suicidal ideation or depression; 10. Congestive heart failure New York Heart Association Functional Classification (NYHA) severity grade III-IV; 11. Used disabled combination medicine; 12. A serious autoimmune disease; 13. Liver dysfunction according to Child-Pugh B/C; 14. Serious acute Infectious diseases; 15. Has a history Malignant in the last 5 years;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentrationafter versus drug dose | baseline to 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Adverse Events of Interest | baseline to 12 weeks | Adverse events of interest to evaluate tolerability are defined as diarrhea, nausea, headache, decreased appetite, insomnia and abdominal pain. |
| Change in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) during the down titration period | baseline to 12 weeks | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing will be performed using spirometry prior to taking study medication |
Countries
China
Outcome results
None listed