Chronic Obstructive Pulmonary Disease (COPD).
Conditions
Interventions
Product Name: Symbicort forte Turbuhaler
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: formoterol/budesonide
Concentration unit: µg microgram(s)
Concentration number: 9/320-
Pharmaceutic
Sponsors
AstraZeneca AB, AstraZeneca Sverige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Male and female aged 40 years and over 3. Established clinical diagnosis of COPD (COPD diagnosis according to GOLD guidelines12) for more than 6 months prior to inclusion in the study 4. Current or previous smoker with a history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year) 5. COPD patients with an acute exacerbation with a history within the last week of progressing dyspnoea and/or increase in sputum production and/or volume within the last week, as judged both by patient and investigator 6. FEV1 of > 30 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients requiring hospitalisation or immediate treatment in an intensive care unit for whatever reason 2. Patients with clinical signs of heart right sided heart failure (e.g peripheral oedema need of treatment with diuretics) 3. Any significant disease or disorder (e.g. pulmonary other than COPD, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) 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 4. Diagnosis/history of asthma 5. Oxygen saturation (SpO2) 1 000 µg/day at study entry 8. Use/in need of non-cardioselective beta-blocking agents 9. Participation in a clinical study evaluating an investigational drug in the last 30 days prior to visit 1 or previous randomisation in this study 10. Previous exacerbation of COPD within 30 days prior to Visit 1 requiring hospitalisation and/or a course of oral steroids and/or antibiotics and/or increased dose of ordinary COPD medication 11. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures as judged by the investigator 12. History of chronic alcohol or drug abuse, difficulties in reading and/or understanding Swedish or any other condition associated with poor compliance 13. Known or suspected hypersensitivity to study therapy or excipients 14. Participation in or scheduled for an intensive COPD rehabilitation program 15. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site) 16. Previous randomisation of treatment in the present study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if a double standard dose of Symbicort forte Turbuhaler during two weeks is as effective as an oral course of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).;Secondary Objective: To assess if disease control is equally well established during twelve weeks follow up treatment with Symbicort forte Turbuhaler following the two weeks acute treatment with either a double standard dose of Symbicort forte Turbuhaler or an oral course of prednisolone + Oxis Turbuhaler.;Primary end point(s): - Forced Expiratory Volume in one second (FEV1) (mean during the two weeks double blind treatment period, i.e. mean of visit 2 and visit 3) | — |
Countries
Finland, Germany, Sweden
Outcome results
None listed