Back to resultsComparison Between Symbicort® and Prednisolone in COPD (SPACE)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
budesonide/formoterol
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
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
Sites / Locations
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Outcomes
Primary Outcome Measures
Forced Expiratory Volume in one second (FEV1)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00259779
Brief Title
Comparison Between Symbicort® and Prednisolone in COPD
Acronym
SPACE
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
budesonide/formoterol
Other Intervention Name(s)
Symbicort
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in one second (FEV1)
Secondary Outcome Measure Information:
Title
Number of patients with treatment failures
Title
Time to first exacerbation
Title
Number of patients developing an exacerbation
Title
Diary cards
Title
Quality of Life
Title
- Adverse Events (AEs)
Title
Serious Adverse Events (SAEs) and Discontinuations due to AEs
Title
Variables will be assessed before and over the 2+12 weeks treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Symbicort Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aalbaek
Country
Denmark
Facility Name
Research Site
City
Aalborg
Country
Denmark
Facility Name
Research Site
City
Christiansfeld
Country
Denmark
Facility Name
Research Site
City
Erfurt
Country
Denmark
Facility Name
Research Site
City
Norager
Country
Denmark
Facility Name
Research Site
City
Oksbol
Country
Denmark
Facility Name
Research Site
City
Saeby
Country
Denmark
Facility Name
Research Site
City
Lohja
Country
Finland
Facility Name
Research Site
City
Pietarsaari
Country
Finland
Facility Name
Research Site
City
Porvoo
Country
Finland
Facility Name
Research Site
City
Tammisaari
Country
Finland
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Leipzig
Country
Germany
Facility Name
Research Site
City
Marburg
Country
Germany
Facility Name
Research Site
City
Fredrikstad
Country
Norway
Facility Name
Research Site
City
Harstad
Country
Norway
Facility Name
Research Site
City
Molde
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Straume
Country
Norway
Facility Name
Research Site
City
Akersberga
Country
Sweden
Facility Name
Research Site
City
Alingsas
Country
Sweden
Facility Name
Research Site
City
Atvidaberg
Country
Sweden
Facility Name
Research Site
City
Borlange
Country
Sweden
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Hollviken
Country
Sweden
Facility Name
Research Site
City
Kilafors
Country
Sweden
Facility Name
Research Site
City
Limhamn
Country
Sweden
Facility Name
Research Site
City
Lindesberg
Country
Sweden
Facility Name
Research Site
City
Lulea
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Motala
Country
Sweden
Facility Name
Research Site
City
Sigtuna
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Trosa
Country
Sweden
Facility Name
Research Site
City
Tumba
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
Facility Name
Research Site
City
Örebro
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
19228428
Citation
Stallberg B, Selroos O, Vogelmeier C, Andersson E, Ekstrom T, Larsson K. Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD. A double-blind, randomised, non-inferiority, parallel-group, multicentre study. Respir Res. 2009 Feb 19;10(1):11. doi: 10.1186/1465-9921-10-11.
Results Reference
derived
Learn more about this trial
Comparison Between Symbicort® and Prednisolone in COPD
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