AsthmaPhase 3NCT00646529
Long-Term Safety of Symbicort in Asthmatic Children - SAPLING
A Phase 3 study testing budesonide/formoterol (Symbicort) and budesonide (Pulmicort) in people with Asthma, run by AstraZeneca.
Trial summary
The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- budesonide/formoterol (Symbicort) and budesonide (Pulmicort)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Oct 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At least 6 and maximally 11 years of age
- Diagnosis of asthma
- Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start
Who cannot join
- Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study
About this study
Official title: A Six Month, Randomized, Open-Label, Safety Study of Symbicort (160/4.5mcg) Compared to Pulmicort Turbuhaler in Asthmatic Children Aged Six to Eleven Years - SAPLING
The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years
- Conditions
- Asthma
- Being tested
- budesonide/formoterol (Symbicort), budesonide (Pulmicort)
- Keywords
- asthma, children, Symbicort, budesonide/formoterol, Pulmicort, budesonide
- 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
budesonide (Pulmicort)Drug
Also called Pulmicort
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | budesonide/formoterol Receives: Drug: budesonide/formoterol (Symbicort) |
| 2 | Active comparator | budesonide Receives: Drug: budesonide (Pulmicort) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol
Measured: 4 assessments within 26 week treatment period
Secondary outcomes (1)
Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort
Measured: 4 assessments within 26 week treatment period
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 startJul 2002
- Study completionOct 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 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
- NCT00646529
- Sponsor's protocol ID
- SD-039-0719
- Other IDs
- D5896C00719
- Status last verified
- Mar 2009
- First submitted
- 26 Mar 2008
- Last updated
- 30 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six Month, Randomized, Open-Label, Safety Study of Symbicort (160/4.5mcg) Compared to Pulmicort Turbuhaler in Asthmatic Children Aged Six to Eleven Years - SAPLING
- ClinicalTrials.gov ID
- NCT00646529
- Acronym / sponsor ID
- SD-039-0719
- Conditions
- Asthma
- Keywords
- asthma, children, Symbicort, budesonide/formoterol, Pulmicort, budesonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- Oct 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 assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years
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: budesonide (Pulmicort)budesonide |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- At least 6 and maximally 11 years of age
- Diagnosis of asthma
- Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start
Key exclusion criteria (2 listed)
- Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study
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 |
| budesonide (Pulmicort)Also: Pulmicort | Drug | 2 |
Primary outcome
Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol
Time frame: 4 assessments within 26 week treatment period
1 secondary outcome
Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort
Time frame: 4 assessments within 26 week 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 30 Mar 2009.
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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 (Symbicort) and budesonide (Pulmicort) 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 30 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?
Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol (time frame: 4 assessments within 26 week treatment period). 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 30 Mar 2009.