Severe Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Trade Name: Symbicort
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BUDESONIDE
CAS Number: 51333223
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 32
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study patients must fulfil all of the following criteria: 1. Provision of informed consent prior to conducting any study-related procedures. 2. Outpatient, female or male aged =40 years. 3. A clinical diagnosis of COPD with symptoms for more than 2 years, prior to visit 2. 4. A current or previous smoker with a smoking history =10 pack years (1 pack year = 20 cigarettes smoked per day for one year). 5. FEV1 =50% of predicted normal value, pre-bronchodilator. 6. FEV1/VC =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. A history of asthma. 2. A history of seasonal allergic rhinitis before 40 years of age. 3. Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder, as judged by the investigator. 4. Any current respiratory tract disorder other than COPD, which is considered by the investigator to be clinically significant. 5. 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 patients ability to participate in the study. 6. Patients taking oral or ophthalmic non-cardioselective ß-blocking agents. 7. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator. 8. Regular oxygen therapy. 9. Known or suspected hypersensitivity to study therapy or excipients of the investigational products. 10. Scheduled in-patient hospitalization during the course of the study. 11. Patients who have participated in a clinical study evaluating an investigational drug in the last 4 weeks (3 months in the UK) prior to visit 2, or who have been previously allocated a randomisation code in this study. 12. Patients with a history of chronic alcohol or drug abuse or any condition associated with poor compliance. 13. Patient participating in or scheduled for an intensive COPD rehabilitation programme during the course of the study. 14. Any clinically relevant abnormal findings in clinical, physical examination, and vital signs at Visit 2, which in the opinion of the investigator(s) may put the patient at risk because of his/her participation in the study (to be checked before allocation of randomisation code at Visit 3). 15. Exacerbation of COPD during run-in or within 4 weeks prior to visit 2 (from end of exacerbation), requiring hospitalisation, a course of oral and/or increased doses of inhaled steroids and/or antibiotics and/or inhaled steroids and/or antibiotics. 16. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site) 17. Use of Oral/parenteral glucocorticosteroids within 4 weeks prior to Visit 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate early morning efficacy of Symbicort Turbuhaler 320/9 µg one inhalation twice daily compared to Seretide Diskus 50/500 µg one inhalation twice daily in patients with severe COPD over one week treatment. ;Secondary Objective: The secondary objective is to evaluate safety by assessing the nature and incidence of adverse events (AEs).;Primary end point(s): The primary efficacy variable will be Peak Expiratory Flow (PEF) 5 minutes after morning dose. | — |
Countries
Denmark, Germany, United Kingdom
Outcome results
None listed