Chronic Obstructive Pulmonary Disease MedDRA version: 9.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Product Code: AZD1981 250mg
Pharmaceutical Form: Tablet
CAS Number: 802904-66-1
Current Sponsor code: AZD1981
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
P
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedure 2. Men, or women = 40 years of age. Women must be either surgically sterilised or post-menopausal ie amenorrhoeic for 12 months and follicle-stimulating hormone (FSH) plasma concentration is within the postmenopausal range as defined by the central laboratory 3. Clinical diagnosis of COPD, with symptoms for more than 1 year before visit 1b 4. BMI between 18 and 30 kg/m2 and a minimum weight of 50 kg 5. Current or ex-smokers with a smoking history of at least 10 pack years 6. FEV1 30-80% of the predicted normal value post-bronchdilator 7. FEV1/FVC=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Any clinically relevant disease or disorder (past or present), including HIV or Hepatitis B or C infection, 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 disorder other than COPD, which is considered by the investigator to be clinically significant or may influence the result of the study 3. History of or current clinically relevant arrhythmia, heart block, intraventricular conduction delay or other clinically relevant ECG abnormalities, or unstable angina, NYHA Class III-IV heart failure, as judged by the investigator 4. Malignancy or neoplastic disease within the past 5 years, other than treated basal/squamous 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. Requirement for long term oxygen therapy 8. An exacerbation of COPD within 30 days of visit 1b 9. Use of oral or systemic GCS within 30 days prior to visit 1b, or during the run-in period 10. Known or suspected hypersensitivity to study therapy or excipients of the investigational product 11. History of or current alcohol abuse or drug abuse, as judged by the investigator 12. Clinical judgement by the investigator that the patient is not suitable to participate in the study. 13. Participation in another study involving study drug administration within 3 months of visit 1b, or within 1 month of visit 1b if the study did not involve study drug administration 14. Blood donation (>500 ml) within 3 months of visit 1b 15. Scheduled inpatient hospitalisation during the study 16. Involvement in the planning and conduct of the study 17. Previous randomization of treatment in the present study For randomization in the study at visit 2 the patients cannot fulfil the following criterion: 18. Use of any non-allowed medication during the run in period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of AZD1981 as compared with placebo in patients with moderate to severe COPD.;Secondary Objective: The secondary objectives are: • to evaluate safety and tolerability of AZD1981 in patients with moderate to severe COPD • to describe plasma exposure of AZD1981 in COPD patients Exploratory objectives are: • to collect blood samples for biomarker analysis including future analysis of biomarkers relevant to COPD and inflammation • to collect pharmacogenetic samples (optional) for possible retrospective pooled analysis.;Primary end point(s): 1. FEV1 pre-bronchodilator (change from baseline (visit 2) to end of treatment) 2. CCQ (change from baseline (visit 2) to end of treatment) | — |
Countries
Bulgaria, Denmark, Slovakia, Sweden
Outcome results
None listed