Chronic Obstructive Pulmonary DiseasePhase 3SPACENCT00259779
Comparison Between Symbicort® and Prednisolone in COPD
A Phase 3 study testing budesonide/formoterol and Prednisolone in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 37 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- budesonide/formoterol and Prednisolone
- How many people
- 120 participants
- Where
- 37 sitesin 5 countries
- Study dates
- Sep 2005to Jul 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
37 sites in 5 countries.
37 sites in 5 countries
Sweden18 sites
Research Site
Åkersberga
Research Site
Alingsås
Research Site
Åtvidaberg
Research Site
Borlänge
Research Site
Gothenburg
Research Site
Höllviken
Research Site
Kilafors
Research Site
Limhamn
Research Site
Lindesberg
Research Site
Luleå
Research Site
Malmö
Research Site
Motala
Research Site
Örebro
Research Site
Sigtuna
Research Site
Stockholm
Research Site
Trosa
Research Site
Tumba
Research Site
Uppsala
Denmark7 sites
Research Site
Aalborg
Research Site
Ålbæk
Research Site
Christiansfeld
Research Site
Erfurt
Research Site
Nørager
Research Site
Oksbøl
Research Site
Sæby
Norway5 sites
Research Site
Fredrikstad
Research Site
Harstad
Research Site
Molde
Research Site
Oslo
Research Site
Straume
Finland4 sites
Research Site
Ekenäs
Research Site
Jakobstad
Research Site
Lohja
Research Site
Porvoo
About this study
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)
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).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- budesonide/formoterol, Prednisolone
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide/formoterolDrug
Also called Symbicort
PrednisoloneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in one second (FEV1)
Secondary outcomes (8)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startSep 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Symbicort Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259779
- Sponsor's protocol ID
- D5892L00002
- Other IDs
- Eudra CT 2005-001090-10, SPACE
- Acronym
- SPACE
- Status last verified
- Jan 2011
- First submitted
- 29 Nov 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Publications
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.
PubMed 19228428
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00259779
- Acronym / sponsor ID
- SPACE / D5892L00002
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonide/formoterolAlso: Symbicort | Drug | – |
| Prednisolone | Drug | – |
Primary outcome
Forced Expiratory Volume in one second (FEV1)
8 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
- Derived from this study: PubMed 19228428Stallberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Symbicort Medical Science Director, MD study director
AstraZeneca
37 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing budesonide/formoterol and Prednisolone in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 37 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Sweden, Denmark, Norway, Finland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume in one second (FEV1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00259779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2011.