SPACE: Comparison Between Symbicort® and Prednisolone in COPD

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00259779

Collaborator

(none)

120

Enrollment

Locations

21.9

Duration (Months)

3.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: budesonide/formoterol Drug: Prednisolone	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2005

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Aalbaek	Denmark
2	Research Site	Aalborg	Denmark
3	Research Site	Christiansfeld	Denmark
4	Research Site	Erfurt	Denmark
5	Research Site	Norager	Denmark
6	Research Site	Oksbol	Denmark
7	Research Site	Saeby	Denmark
8	Research Site	Lohja	Finland
9	Research Site	Pietarsaari	Finland
10	Research Site	Porvoo	Finland
11	Research Site	Tammisaari	Finland
12	Research Site	Berlin	Germany
13	Research Site	Leipzig	Germany
14	Research Site	Marburg	Germany
15	Research Site	Fredrikstad	Norway
16	Research Site	Harstad	Norway
17	Research Site	Molde	Norway
18	Research Site	Oslo	Norway
19	Research Site	Straume	Norway
20	Research Site	Akersberga	Sweden
21	Research Site	Alingsas	Sweden
22	Research Site	Atvidaberg	Sweden
23	Research Site	Borlange	Sweden
24	Research Site	Goteborg	Sweden
25	Research Site	Hollviken	Sweden
26	Research Site	Kilafors	Sweden
27	Research Site	Limhamn	Sweden
28	Research Site	Lindesberg	Sweden
29	Research Site	Lulea	Sweden
30	Research Site	Malmo	Sweden
31	Research Site	Motala	Sweden
32	Research Site	Sigtuna	Sweden
33	Research Site	Stockholm	Sweden
34	Research Site	Trosa	Sweden
35	Research Site	Tumba	Sweden
36	Research Site	Uppsala	Sweden
37	Research Site	Örebro	Sweden