Comparison Between Symbicort® and Prednisolone in COPD

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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