AsthmaPhase 3NCT00646594
Atlantis Symbicort
A Phase 3 study testing budesonide/formoterol (Symbicort) and fluticasone/salmeterol (Advair) in people with Asthma, run by AstraZeneca.
Trial summary
The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents. 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 (Symbicort) and fluticasone/salmeterol (Advair)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Jan 2005
- 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
- Diagnosis of asthma
- Baseline lung function tests as determined by protocol
- Required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol
Who cannot join
- Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a beta-blockers
- Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator
About this study
Official title: A Two Stage Randomized, Open-Label, Parallel Group, Phase III, Multicenter, 7 Month Study to Assess the Efficacy & Safety of SYMBICORT pMDI Adminstered Either as Fixed or as an Adjustable Regimen Versus a Fixed Regimen of Advair in Subjects 12 Yrs of Age and Older With Asthma.
The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.
- Conditions
- Asthma
- Being tested
- budesonide/formoterol (Symbicort), fluticasone/salmeterol (Advair)
- Keywords
- Asthma, inhaled cortocisteroids, Symbicort, budesonide/formoterol, Advair, fluticasone/salmeterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide/formoterol (Symbicort)Drug
Also called Symbicort
fluticasone/salmeterol (Advair)Drug
Also called Advair
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | budesonide/formoterol Receives: Drug: budesonide/formoterol (Symbicort) |
| 2 | Active comparator | fluticasone/salmeterol Receives: Drug: fluticasone/salmeterol (Advair) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control assessed by asthma exacerbations
Measured: Continuosly throughout the treatment period
Secondary outcomes (3)
Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.
Measured: Daily and at 1, 3 and 6 months after start of treatmen
Use of medical resources and medication for the treatment of asthma.
Measured: Throughout the treatment period
Investigate safety profile of Symbicort compared to Advair
Measured: 1, 3 and 6 months after start of treatment and 1 week after end of tretment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startNov 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mitchell Golmand, MD, Study director, AstraZenecaCatherine Bonuccelli, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646594
- Sponsor's protocol ID
- D5896C00005
- Status last verified
- Mar 2009
- First submitted
- 26 Mar 2008
- Last updated
- 27 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162O'Connor RD, Patrick DL, Parasuraman B, Martin P, Goldman M. Comparison of patient-reported outcomes during treatment with adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler versus fixed-dose fluticasone propionate/salmeterol dry powder inhaler in patients with asthma. J Asthma. 2010 Mar;47(2):217-23. doi: 10.3109/02770900903497154.
PubMed 20170333
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Stage Randomized, Open-Label, Parallel Group, Phase III, Multicenter, 7 Month Study to Assess the Efficacy & Safety of SYMBICORT pMDI Adminstered Either as Fixed or as an Adjustable Regimen Versus a Fixed Regimen of Advair in Subjects 12 Yrs of Age and Older With Asthma.
- ClinicalTrials.gov ID
- NCT00646594
- Acronym / sponsor ID
- D5896C00005
- Conditions
- Asthma
- Keywords
- Asthma, inhaled cortocisteroids, Symbicort, budesonide/formoterol, Advair, fluticasone/salmeterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Jan 2005 (actual)
- First posted
- 28 Mar 2008 (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 determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: budesonide/formoterol (Symbicort)budesonide/formoterol |
| 2 | Active comparator | Drug: fluticasone/salmeterol (Advair)fluticasone/salmeterol |
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)
- Diagnosis of asthma
- Baseline lung function tests as determined by protocol
- Required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol
Key exclusion criteria (2 listed)
- Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a beta-blockers
- Had cancer within previous 5 years or currently has any other significant disease or disorder as judged 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/formoterol (Symbicort)Also: Symbicort | Drug | 1 |
| fluticasone/salmeterol (Advair)Also: Advair | Drug | 2 |
Primary outcome
Asthma control assessed by asthma exacerbations
Time frame: Continuosly throughout the treatment period
3 secondary outcomes
Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.
Time frame: Daily and at 1, 3 and 6 months after start of treatmen
Use of medical resources and medication for the treatment of asthma.
Time frame: Throughout the treatment period
Investigate safety profile of Symbicort compared to Advair
Time frame: 1, 3 and 6 months after start of treatment and 1 week after end of tretment
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 27 Mar 2009.
- Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
- Derived from this study: PubMed 20170333O'Connor RD, Patrick DL, Parasuraman B, Martin P, Goldman M. Comparison of patient-reported outcomes during treatment with adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler versus fixed-dose fluticasone propionate/salmeterol dry powder inhaler in patients with asthma. J Asthma. 2010 Mar;47(2):217-23. doi: 10.3109/02770900903497154.
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Asthma
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.
Mitchell Golmand, MD study director
AstraZeneca
Catherine Bonuccelli study chair
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing budesonide/formoterol (Symbicort) and fluticasone/salmeterol (Advair) in people with Asthma, run by AstraZeneca.
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 2 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 27 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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 control assessed by asthma exacerbations (time frame: Continuosly throughout the treatment period). 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 NCT00646594, which also lists 2 linked publications.
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 27 Mar 2009.