Comparison Between Symbicort® and Prednisolone in COPD (SPACE)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: budesonide/formoterol; Drug: Prednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259779

D5892L00002

Eudra CT 2005-001090-10

SPACE

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind