Comparison Between Symbicort® and Prednisolone in COPD

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00259779
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-11-29
• Study First Submitted QC: 2005-11-29
• Study First Posted: 2005-12-01
• Study Completion: 2007-07
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in one second (FEV1)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Örebro, Sweden