AsthmaPhase 3NCT00646009
Symbicort Onset of Action 2
A Phase 3 study testing budesonide/formoterol, fluticasone/salmeterol and albuterol in people with Asthma, run by AstraZeneca.
Trial summary
The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- budesonide/formoterol, fluticasone/salmeterol and albuterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Aug 2003
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Diagnosis of asthma and baseline lung function test results as determined by the protocol
- Required and received inhaled corticosteroids within timeframe and doses specified in the protocol
Who cannot join
- Severe asthma or asthma that is markedly effected by seasonal factors
- Has required and received non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
About this study
Official title: A Randomized, Multicenter, Placebo and Active-controlled, Single-dose, 4-period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.
The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma
- Conditions
- Asthma
- Being tested
- budesonide/formoterol, fluticasone/salmeterol, albuterol
- Keywords
- asthma, adults, Symbicort, budesonide/formoterol, Advair Diskus, Ventolin
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide/formoterolDrug
Also called Symbicort
fluticasone/salmeterolDrug
Also called Advair Diskus
albuterolDrug
Also called Ventolin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | budesonide/formoterol Receives: Drug: budesonide/formoterol |
| 2 | Active comparator | fluticasone/salmeterol Receives: Drug: fluticasone/salmeterol |
| 3 | Active comparator | albuterol Receives: Drug: albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 3 minutes post dose
Measured: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Secondary outcomes (2)
12 hour serial FEV1
Measured: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Patients perception of effect
Measured: Patients perception of effect
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 startMar 2003
- Study completionAug 2003
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
- Crossover
- Masking
- Double blind
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Catherine Bonuccelli, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646009
- Sponsor's protocol ID
- SD-039-0733
- Other IDs
- D5896C00733
- Status last verified
- Jan 2011
- First submitted
- 26 Mar 2008
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- 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
- A Randomized, Multicenter, Placebo and Active-controlled, Single-dose, 4-period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.
- ClinicalTrials.gov ID
- NCT00646009
- Acronym / sponsor ID
- SD-039-0733
- Conditions
- Asthma
- Keywords
- asthma, adults, Symbicort, budesonide/formoterol, Advair Diskus, Ventolin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Aug 2003 (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 compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: budesonide/formoterolbudesonide/formoterol |
| 2 | Active comparator | Drug: fluticasone/salmeterolfluticasone/salmeterol |
| 3 | Active comparator | Drug: albuterolalbuterol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Diagnosis of asthma and baseline lung function test results as determined by the protocol
- Required and received inhaled corticosteroids within timeframe and doses specified in the protocol
Key exclusion criteria (2 listed)
- Severe asthma or asthma that is markedly effected by seasonal factors
- Has required and received non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
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 | 1 |
| fluticasone/salmeterolAlso: Advair Diskus | Drug | 2 |
| albuterolAlso: Ventolin | Drug | 3 |
Primary outcome
FEV1 3 minutes post dose
Time frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
2 secondary outcomes
12 hour serial FEV1
Time frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Patients perception of effect
Time frame: Patients perception of effect
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.
Catherine Bonuccelli study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing budesonide/formoterol, fluticasone/salmeterol and albuterol 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 24 Jan 2011. 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?
FEV1 3 minutes post dose (time frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)). 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.