Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Product Code: AZD1981 250 mg
Pharmaceutical Form: Tablet
CAS Number: 802904-66-1
Current Sponsor code: AZD1981
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion into the run-in period of the study patients must fulfil all of the following criteria: 1. Provision of informed consent prior to any study-specific procedure 2. Men or women =40 years of age. Women must be either permanently surgically sterilised or post-menopausal, ie, amenorrhoeic for 12 months and FSH within the post-menopausal range as defined by the central laboratory 3. Clinical diagnosis of COPD, with symptoms for more than 1 year before visit 1a 4. BMI between 18 and 35 kg/m2 and a minimum weight of 50 kg 5. Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year=20 cigarettes smoked per day for 1 year) 6. FEV1 40-80% of the predicted normal (PN) value post-bronchodilator 7. FEV1/FVC post-bronchodilator =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 human immunodeficiency virus or Hepatitis B or C infection or previous bone marrow transplant, 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. History of or current clinically relevant arrhythmia, heart block, intraventricular conduction delay or other clinically relevant ECG abnormalities, or unstable angina, New York Heart Association Class III-IV heart failure, as judged by the investigator 4. Malignancy or neoplastic disease within the past 5 years, other than treated basal 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. Requirement for long-term oxygen therapy 8. An exacerbation of COPD (use of antibiotics and/or systemic glucocorticosteroid [GCS] and/or hospitalisation related to COPD) within 30 days of visit 1a 9. Use of oral or systemic GCS within 30 days prior to visit 1a, or during the run-in period 10. Known or suspected hypersensitivity to study therapy or excipient of the investigational product 11. History of current alcohol abuse or drug abuse, as judged by the investigator 12. Clinical judgement by the investigator that the patient should not participate in the study 13. Participation in another study involving study drug administration within 3 months of visit 1a, or within 1 month of visit 1a if the study did not involve study drug administration (eg, method development study) 14. Blood donation (>450 mL) within 3 months of visit 1a 15. Scheduled inpatient surgery or hospitalisation during the study 16. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 17. Previous randomisation into the study 18. Contraindication for bronchoscopy, including contraindications or hypersensitivity to medications used as pre-medication for bronchoscopy 19. Contraindication for biopsy, including uncontrolled coagulopathies that would increase the bleeding risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the effects of 4 weeks treatment with AZD1981 on histology (lung tissue biopsy) and cellularity (broncho alveolar lavage [BAL]) and 3 weeks treatment with AZD1981 on cellularity (induced sputum) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).;Secondary Objective: The secondary objectives are: 1. To evaluate the efficacy of AZD1981 compared with placebo on COPD symptoms and functional endpoints in patients with moderate to severe COPD 2. To evaluate safety and tolerability of AZD1981 in patients with moderate to severe COPD 3. To describe the plasma exposure of AZD1981 in patients with moderate to severe COPD. The Exploratory objectives are: 1. To retain a sample of plasma, BAL and sputum for potential future retrospective analysis of mediators (multiplex) relevant to the mechanism of inflammation in COPD 2. To collect pharmacogenetic (PGx) samples (optional) for possible retrospective pooled analysis.;Primary end point(s): - Aggregate pathology score - Cell counts of BAL fluid and induced sputum | — |
Countries
Germany, United Kingdom
Outcome results
None listed