COPD
Conditions
Interventions
Endobronchial biopsy and bronchoalveolar lavage during visit 1b and 6.
Sponsors
Astra Zeneca
Eligibility
Age
18 Years to 99 Years
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 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 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 (1 pack year
Exclusion criteria
Exclusion criteria: 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. The following is regarded as a criterion for exclusion from randomisation to the study: 20. Use of any non-allowed medication during the run-in period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Primary outcome variables: * Aggregate pathology score * Cell counts of BAL fluid and induced sputum | — |
Secondary
| Measure | Time frame |
|---|---|
| * Secondary outcome variables: * Lung function: FEV1, FVC, slow vital capacity (SVC), inspiratory capacity (IC), the mean Forced Expiratory Flow (FEF) between 25% and 75% of the FVC (FEF25-75%) * Functional capacity by the 6-minute walk test (6MWT) * Borg CR10® Scale (in connection with 6MWT) * Clinical COPD Questionnaire (CCQ). * St George*s Respiratory Questionnaire for COPD patients (SGRQ-C) * Diary card variables (COPD symptoms, Peak Expiratory Flow [PEF] morning and evening, use of reliever medication) * Modified Medical Research Council (MMRC) dyspnoea scale * Exploratory outcome variables: * The BODE index, which is a composite variable of: body mass index (B), airway obstruction as assessed by FEV1 (O), dyspnoea as assessed by the MMRC dyspnoea scale (D), exercise capacity as assessed by 6MWT (E) * Blood sample and BAL/sputum for future biomarker (multiplex) exploratory analysis. | — |
Countries
Netherlands
Outcome results
None listed