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
Interventions
Product Code: AZD1236
Pharmaceutical Form: Tablet
Current Sponsor code: AZD1236
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the plac
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 40-80% 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 disorders other than COPD, which are 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 mm in 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 finding 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 30 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 be ing 1.23 for me n and 1.04 for women 8. Known HIV infection, or patient who belong to high risk group of 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 (use of oral or parenteral antibiotics and/or oral or parenteral glucocorticosteroids and/or hospitalisation related to COPD) within 30 days of Visit 2 or during run-in 13. Use of oral or parenteral glucocorticosteroids within 30 days prior to Visit 2, or during the run-in period 14. Use of inhaled glucocorticosteroids within 14 days prior to Visit 2 or during the run-in period 15. Known or suspected hypersensitivity to study therapy or excipients of the investigational product 16. History of, or current alcohol abuse or drug abuse, as judged by the investigator 17. Scheduled in-patient hospitalisation during the course of the study 18. Donation of blood within 3 months prior to Visit 2 19. Vaccination within 2 weeks prior to Visit 2 20. Previous randomisation of treatment in the present study 21. Participation in another study involving drug administration within 3 months of Visit 2 22. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 23. 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: 24. Whole blood transfusion within 120 days of the date of genetic sample collection 25. Previous bone marrow transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives are to assess the effects of AZD1236 on lung function and COPD symptoms, the safety and tolerability of AZD1236 and the systemic exposure of AZD1236. A genetic sample will be collected from patients giving separate informed consent for this.;Primary end point(s): Safety Adverse events, blood pressure, pulse, ECG and laboratory safety variables (clinical chemistry, haematology, urinalysis).;Main Objective: The primary objective is to assess the effects of AZD1236 compared with placebo on selected biomarkers in induced sputum, urine and blood in patients with moderate to severe chronic obstructive pulmonary disease (COPD). | — |
Countries
Denmark, Finland, Netherlands
Outcome results
None listed