Chronic Obstructive Pulmonary Disease (study conducted in men or women, not of child bearing potential, aged 40 years or above). MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Men, or postmenopausal/hysterectomised/oophorectomised women = 40 years of age. Postmenopausal women defined as being amenorrhoeic for at least 24 months. 3. A minimum weight of 50 kg 4. Diagnosis of COPD for at least 1 month 5. FEV1 30 to 80 % of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any clinically relevant disease or disorder (past or present), which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient’s ability to participate in the study 2. Any current respiratory tract disorder other than COPD, which is considered by the investigator to be clinically significant or may influence the result of the study 3. A clinical suspicion of active or latent tuberculosis defined as any of the following: a) positive tuberculosis test (such as Quantiferon-GOLD or Mantoux-test (>5 mmin unvaccinated individuals and >10 mm in individuals with previous BCG-vaccination), and/or b) suspicion of active or latent tuberculosis on chest X-ray taken within last 12 months. and/or c) past medical history of tuberculosis 4. Malignancy or neoplastic disease within the last 5 years, other than treated basal/squamous cell skin cancer or treated cervical cancer in situ 5. Disease history suggesting reduced or abnormal immune function 6. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study 7. Patients with glomerular filtration rate less than 60 mL/min, calculated as creatinine clearance from serum-creatinine according to the Cockcroft and Gault formula: (CLcreatinine (mL/min)=constant x (140-age) x weight (kg)/serum creatinine (µM). Constant being 1.23 for men and 1.04 for women. 8. Known HIV infection, or patients who belong to a high risk group for HIV 9. Increased Cardiac Troponin I>Upper Limit of Normal (ULN) at Visit 2 10. Patients with underlying musculoskeletal symptoms of unknown origin and patients with shoulder girdle musculoskeletal symptoms or Dupuytrens contracture symptoms as judged by the Investigator 11. Requirement for regular oxygen therapy 12. An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or oral or parenteral glucocorticosteroids (GCS) and/or hospitalization related to COPD) within 30 days of Visit 2, or during the run-in period 13. Use of oral or parenteral glucocorticosteroids within 30 days prior to Visit 2, or during the run-in period 14. Known or suspected hypersensitivity to study therapy or excipients of the investigational product 15. History of, or, current alcohol or drug abuse, as judged by the investigator 16. Scheduled in-patient hospitalization during the course of the study 17. Donation of blood within 3 months prior to Visit 2 18. Vaccination within 2 weeks prior to Visit 2 19. Previous randomisation of treatment in the present study 20. Participation in another clinical study involving drug administration during the last 3 months before Visit 2 21. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 22. Clinical judgement by the investigator that the patient should not participate in the study If the patient participates in the genetic part of the study these exclusion criteria apply as well: 23. Whole blood transfusion within 120 days of the date of genetic sample collection 24. Previous bone marrow transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the tolerability and safety of AZD1236, as an oral tablet, in COPD patients by assessment of: incidence and nature of adverse events vital signs and laboratory safety assessments;Secondary Objective: To assess the effects of AZD1236 compared with placebo on lung function, COPD symptoms, functional capacity, the BODE index, selected biomarkers in urine and blood and systemic exposure of AZD1236.;Primary end point(s): Safety Adverse events, blood pressure, pulse, electrocardiogram and laboratory safety variables (clinical chemistry, haematology, urinalysis). | — |
Countries
Bulgaria, Finland, Germany, Hungary
Outcome results
None listed