Comparison Between Symbicort® and Prednisolone in COPD

AstraZeneca120 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

budesonide/formoterolDRUG

PrednisoloneDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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 exclusion criteria will be evaluated by the investigator

Locations (37)

Research Site

Aalborg, Denmark

Outcomes

Primary Outcomes

Forced Expiratory Volume in one second (FEV1)

Secondary Outcomes

Number of patients with treatment failures

Time to first exacerbation

Number of patients developing an exacerbation

Diary cards

Quality of Life

- 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

Data from ClinicalTrials.gov

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