Severe 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. Provision of informed consent prior to conducting any study-related procedure 2. Out-patient, man or woman =40 years of age 3. A clinical diagnosis of COPD, and symptoms for more than 2 years prior to visit 2 4. A current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year) 5. A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before visit 2 6. FEV1=50% of predicted normal value (pre-bronchodilator) 7. FEV1/VC=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A history of asthma. 2. A history of seasonal allergic rhinitis before 40 years of age 3. Exacerbation of COPD during run-in or within 4 weeks (end of exacerbation) prior to visit 2, requiring hospitalisation, a course of oral and/or inhaled steroids and/or antibiotics 4. Significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator 5. Regular oxygen therapy 6. Any current respiratory tract disorder other than COPD, which is considered by the investigator to be clinically significant 7. Any significant disease or disorder 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 8. Signs and symptoms of peripheral arterial occlusion 9. SaO2=90% at rest 10. Any abnormality in ECG that could put patient at risk while performing exercise testing, as judged by the investigator 11. Patient taking non-cardioselective ß-blocking agents 12. Use of inhaled corticosteroids within 2 weeks prior to visit 2 and during run-in. 13. Use of oral/parenteral corticosteriods within 4 weeks prior to visit 2 and during run-in. 14. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures. Acceptable contraceptive methods are methods of birth control which result in a low failure rate (ie, less than 1 % per year) when used constantly and correctly such as implants, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner 15. Known or suspected hypersensitivity to study therapy or excipients of the investigational products 16. Scheduled in-patient hospitalisation during the course of the study 17. Patients who have participated in a clinical study evaluating an investigational product in the last 4 weeks prior to enrolment, or during this study, or who have been previously allocated a randomisation code in this study 18. Patients with a history of chronic alcohol or drug abuse or any condition associated with poor compliance 19. Patients participating in or scheduled for an intensive COPD rehabilitation program 20. Any clinically relevant abnormal findings in physical examination and vital signs, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study 21. Planned donation of blood during the study 22. 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 |
|---|---|
| Primary end point(s): The Primary efficacy variable will be: - Exercise Endurance Time (EET) performed at 75% of Peak Work Capacity (Wmax) with cycle ergometry (1 hour post dose);Secondary Objective: The secondary objective of the study is to evaluate safety by assessing the nature and incidence of AEs. ;Main Objective: The primary objective of this study is to compare the efficacy on exercise tolerance of Symbicort Turbuhaler 320/9 microgram twice daily compared to placebo and Oxis Turbuhaler 9 microgram twice daily in patients with severe COPD by evaluation of the Exercise Endurance Time (EET) measured at 75% of Wmax with cycle ergometry 1 hour post-dose at visits 5, 7 and 9 (end of each treatment period) as the primary outcome variable. | — |
Countries
Germany
Outcome results
None listed