Chronic obstructive pulmonary disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be willing and able to comply with study procedures and provide written informed consent 2. Be male or post-menopausal (for more than 12 months)/surgically sterile female between 40 and 80 years 3. Have a clinical diagnosis of COPD 4. Smokers or ex-smokers (with at least 10 pack years) 5. Post-bronchodilator FEV1 30 - 80% predicted, FEV1/FVC ratio =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Concomitant diagnosis of significant pulmonary disease other than COPD, including symptomatic asthma, cystic fibrosis and allergic bronchopulmonary aspergillosis 2. An acute exacerbation (defined as an increase in respiratory symptoms requiring hospitalisation and/or a course of oral glucocorticosteroids and/or antibiotics, either prescribed or self administered); or acute respiratory infection (upper or lower) in the 4 weeks prior to Visit 1 or Visit 2 3. Use of oral corticosteroids in the 8 weeks prior to Visit 2 (use of inhaled corticosteroids is allowed) 4. Use of antibiotics, systemically or nebulised, in the 4 weeks prior to Visit 1 or Visit 2 5. Current requirement for oxygen therapy 6. Any other clinical disease or disorder (including insulin-dependent diabetes) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study 7. Positive test result for HIV, Hepatitis B or C 8. Scheduled in-patient surgery or hospitalisation during the course of the study 9. Previous randomisation into the present study 10. Participation in another clinical study involving an investigational product within 4 weeks or 5 times the half life, whichever is longer, of Visit 1 11. A past history of or current clinical or laboratory evidence of renal disease, or a calculated creatinine clearance (Cockcroft-Gault formula) of =70 ml/min at Visit 1 12. (a) QTc >450 ms for males and >470 ms for females in the screening ECG (b) The presence of any arrhythmia in the ECG at Visit 1. which in the opinion of the investigator may put the patient at risk or interfere with study assessments. (Premature ventricular or supraventricular ectopics up to 6/minute will be allowed at the investigators discretion, as long as there are no other associated cardiac abnormalities) (c) Current or previous history of coronary artery disease, or congestive cardiac failure or any other clinically significant cardiac disease 13. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, ECG or lung function at Visit 1, which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study. 14. Patients who, in the opinion of the investigator, should not participate in the study. 15. History of excessive alcohol consumption or chronic alcohol induced disease. Excessive alcohol consumption will be defined as the consumption >28 units/week in males or >21 units in females [1 unit is equivalent to half a pint (285 ml) of beer, 1 glass (125 ml) of wine or 1 measure (25 ml) of spirits]. 16. If participation in the study would result in the volunteer donating more than 1350 mL of blood in the 12 months or 500 mL of blood in the 3 months before the end of the study 17. The patient is not able to understand and comply with protocol requirements, instructions and protocol-stated restriction 18. Vulnerable patients (e.g. persons kept in detention). 19. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To investigate the tolerability of 14 days’ dosing with AZD9668 in patients with COPD, as measured by vital signs, ECG, lung function, haematology, clinical chemistry, urinalysis and adverse event reporting. 2. To determine the plasma pharmacokinetics and renal clearance of AZD9668 in patients with COPD. ;Secondary Objective: 1. To assess the effect of orally administered AZD9668 on neutrophils in induced sputum of patients with COPD. 2. To investigate the effects of AZD9668 on sputum bacteriology. 3. To measure the concentration of AZD9668 in induced sputum following oral administration. ;Primary end point(s): Tolerability: Adverse events, vital signs, ECG, lung functions, haematology, clinical chemistry, and urinalysis. Pharmacokinetic: AZD9668 plasma and urine concentrations Day 1: Cmax, tmax, AUC(0-t), AUC(0-24), C24, AUC, t1/2, CL/F, Vz/F, CLR, Ae and Fe (%) Day 7: Cmin,ss Day 14: Cmin,ss, C,max,ss, tmax, AUC(0-t),ss, AUC(0-24),ss, C24,ss, AUCss, t1/2ss, CL/Fss, Vz/Fss, Rac, CLR, Ae,ss and Fe,ss (%) | — |
Countries
Germany
Outcome results
None listed