Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief summary
To assess if 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).
Interventions
DRUGbudesonide/formoterol
DRUGPrednisolone
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with chronic obstructive pulmonary disease and an acute exacerbation * After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value. * Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease
Exclusion criteria
* Diagnosis/history of asthma * Oxygen uptake (saturation) is \<92% after the initial acute treatment * A requirement for regular use of oxygen therapy * Regular treatment with any inhaled steroid \>1 000 µg/day at study entry Additional inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced Expiratory Volume in one second (FEV1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first exacerbation | — |
| Number of patients developing an exacerbation | — |
| Diary cards | — |
| Number of patients with treatment failures | — |
| - Adverse Events (AEs) | — |
| Serious Adverse Events (SAEs) and Discontinuations due to AEs | — |
| Variables will be assessed before and over the 2+12 weeks treatment period | — |
| Quality of Life | — |
Countries
Denmark, Finland, Germany, Norway, Sweden
Outcome results
None listed