NCT00259779
Completed
Phase 3
A Randomised, Double Blind, Double Dummy, Multicentre Phase III Study Comparing the Efficacy of Budesonide/Formoterol (Symbicort® Forte Turbuhaler®) and Oral Prednisolone + Formoterol (Oxis® Turbuhaler) During Two Weeks, in COPD Patients With an Acute Exacerbation, Followed by Twelve Weeks Open Follow up Period With Budesonide/Formoterol (Symbicort Forte Turbuhaler)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- AstraZeneca
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Forced Expiratory Volume in one second (FEV1)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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).
Investigators
Eligibility 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
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
Study Sites (1)
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