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. Outpatient, man or woman =40 years 3. A clinical diagnosis of COPD, and symptoms for more than 2 years 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 dose of oral steroids and/or antibiotics within 1 to 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. Worsening of COPD during run-in or within 4 weeks prior to Visit 2, requiring hospitalisation, a course of oral and/or inhaled steroids and/or antibiotics 2. Use of inhaled glucocorticosteroids within 2 weeks prior to Visit 2 3. Use of oral/parenteral glucocorticosteroids within 4 weeks prior to Visit 2 4. 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 5. A history of asthma 6. A history of seasonal allergic rhinitis before 40 years of age 7. Significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, renal failure, uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator 8. Regular oxygen therapy 9. Any current respiratory tract disorder other than COPD, which is considered by the Investigator to be clinically significant 10. 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 may influence the results of the study, or the patient’s ability to participate in the study 11. Patients with clinically significant narrow-angle glaucoma, significant prostatic hyperplasia or bladder-neck obstruction in whom treatment with tiotropium may be related to worsening of signs and symptoms related to these conditions, as judged by the Investigator 12. Patients taking non-cardioselective ß-blocking agents 13. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the Investigator 14. Known or suspected hypersensitivity to study therapy or excipients of the study drugs, including atropine or its derivatives, and ipratropium and any component of this product, as judged by the Investigator 15. Scheduled in-patient hospitalization during the course of the study 16. Patients who have participated in a clinical study evaluating an investigational drug in the last 4 weeks prior to enrolment, or who have been previously allocated a randomisation code in this study 17. Patients with a history of chronic alcohol or drug abuse or any condition associated with poor compliance 18. Patients participating in or scheduled for an intensive COPD rehabilitation program 19. Planned donation of blood during the study 20. 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: The primary objective of this study is to evaluate the efficacy on lung function of tiotropium bromide (Spiriva®, Boehringer Ingelheim) 18 µg one inhalation once daily + budesonide/formoterol (Symbicort®) Turbuhaler® 320/9 µg one inhalation twice daily compared to Spiriva 18 µg one inhalation once daily alone. ;Secondary Objective: The secondary objective of the study is to evaluate safety by assessing the nature, incidence and severity of adverse events (AEs) and vital signs within the treatment groups. ;Primary end point(s): The primary outcome variable will be pre-dose Forced Expiratory Volume in 1 second (FEV1) assessed by spirometry at clinic visits. | — |
Countries
France, Germany, Hungary, Spain, Sweden
Outcome results
None listed