AsthmaPhase 3NCT00259766
SHARE - Symbicort and Health Economics in a Real Life Evaluation
A Phase 3 study testing Budesonide, Formoterol and Terbutaline in people with Asthma, run by AstraZeneca at 108 sites in Sweden.
Trial summary
The purpose of this study is to compare health-related costs and asthma control in ordinary clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and Symbicort fixed dosing plus Bricanyl as… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide, Formoterol and Terbutaline
- How many people
- 1,970 participants
- Where
- 108 sitesSweden
- Study dates
- Apr 2004to May 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent,
- asthma,
- previously treated with glucocorticosteroids and B2-agonist
Who cannot join
- History of smoking, pregnancy, any significant disease or disorder which may put the patient at risk because of study participation
Trial locations and contacts
108 sites in 1 country.
108 sites in 1 country
Sweden108 sites
Research Site
Åkersberga
Research Site
Alingsås
Research Site
Ånge
Research Site
Ängelholm
Research Site
Angered
Research Site
Arlöv
Research Site
Årsta
Research Site
Arvidsjaur
Research Site
Arvika
Research Site
Åstorp
Research Site
Åtvidaberg
Research Site
Bandhagen
Research Site
Boden
Research Site
Borensberg
Research Site
Bro
Research Site
Brunflo
Research Site
Eskilstuna
Research Site
Falun
Research Site
Filipstad
Research Site
Fränsta
Research Site
Gagnef
Research Site
Gärsnäs
Research Site
Gothenburg
Research Site
Grängesberg
Research Site
Gullspång
Research Site
Håby
Research Site
Halmstad
Research Site
Helsingborg
Research Site
Hisingsbacka
Research Site
Hofors
Research Site
Höganäs
Research Site
Höllviken
Research Site
Huddinge
Research Site
Iggesund
Research Site
Jarfalla
Research Site
Kalmar
Research site
Karlskoga
Research Site
Karlstad
Research Site
Katrineholm
Research Site
Kil
Research Site
Kinna
Research Site
Klippan
Research Site
Kolmården
Research Site
Kristinehamn
Research Site
Kungälv
Research Site
Kungsbacka
Research Site
Kungsör
Research Site
Landskrona
Research Site
Laxå
Research Site
Leksand
Research Site
Lerum
Research Site
Lidingö
Research Site
Likenäs
Research Site
Limhamn
Research Site
Lindome
Research Site
Linköping
Research Site
Ljungskile
Research Site
Ludvika
Research Site
Luleå
Research Site
Lund
Research Site
Malmö
Research Site
Mariefred
Research Site
Mölndal
Research site
Mölnlycke
Research Site
Nacka
Research Site
Norrköping
Research Site
Norrtälje
Research Site
Nyköping
Research site
Ödeshög
Research Site
Örebro
Research site
Osby
Research Site
Påarp
Research Site
Partille
Reseearch Site
Perstorp
Research Site
Saltsjo-Bo
Research Site
Sandviken
Research Site
Sjöbo
Research Site
Sjuntorp
Research Site
Söderköping
Research site
Sollentuna
Research Site
Solna
Research site
Stenstorp
Research Site
Stenungsund
Research Site
Stockholm
Research Site
Storfors
Research Site
Stugun
Research Site
Sundbyberg
Research Site
Sundsvall
Research Site
Sunne
Research Site
Täby
Research Site
Trollhättan
Research Site
Trosa
Research Site
Tyresö
Research Site
Uddevalla
Research site
Ulricehamn
Research Site
Umeå
Research Site
Uppsala
Research Site
Vallentuna
Research Site
Vännäs
Research Site
Varberg
Research Site
Värnamo
Research site
Väsby
Research Site
Västerås
Research Site
Västervik
Research site
Västra Frölunda
Research Site
Vellinge
Research Site
Ystad
Research Site
Ytterby
About this study
Official title: Symbicort and Health Economics in a Real Life Evaluation - SHARE - A Randomised, Open-Label, Parallel-Group, Multicentre Study to Assess the Asthma-Related Health-Care Costs, in Ordinary Clinical Practice During 12 Months
The purpose of this study is to compare health-related costs and asthma control in ordinary clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and Symbicort fixed dosing plus Bricanyl as needed in asthmatic patients not adequately controlled on inhaled glucocorticosteroids alone.
- Conditions
- Asthma
- Being tested
- Budesonide, Formoterol, Terbutaline
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Also called Symbicort
FormoterolDrug
TerbutalineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities
Secondary outcomes (2)
Number of days patients or assistant persons are absent from work due to patient's asthma
Number of exacerbations and treatment failures
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 startApr 2004
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- None (open label)
- Enrolment
- 1,970 participants
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
- NCT00259766
- Sponsor's protocol ID
- D5890L00001
- Other IDs
- SHARE
- Status last verified
- Jan 2011
- First submitted
- 25 Nov 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
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
- Symbicort and Health Economics in a Real Life Evaluation - SHARE - A Randomised, Open-Label, Parallel-Group, Multicentre Study to Assess the Asthma-Related Health-Care Costs, in Ordinary Clinical Practice During 12 Months
- ClinicalTrials.gov ID
- NCT00259766
- Acronym / sponsor ID
- D5890L00001
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,970 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- May 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.
The purpose of this study is to compare health-related costs and asthma control in ordinary clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and Symbicort fixed dosing plus Bricanyl as needed in asthmatic patients not adequately controlled on inhaled glucocorticosteroids alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent,
- asthma,
- previously treated with glucocorticosteroids and B2-agonist
Key exclusion criteria (1 listed)
- History of smoking, pregnancy, any significant disease or disorder which may put the patient at risk because of study participation
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 |
|---|---|---|
| BudesonideAlso: Symbicort | Drug | – |
| Formoterol | Drug | – |
| Terbutaline | Drug | – |
Primary outcome
Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities
2 secondary outcomes
Number of days patients or assistant persons are absent from work due to patient's asthma
Number of exacerbations and treatment failures
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.
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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
108 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide, Formoterol and Terbutaline in people with Asthma, run by AstraZeneca at 108 sites in Sweden.
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 1 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 108 sites in Sweden. 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?
Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.