AsthmaPhase 3NCT00651547
Symbicort in Asthmatic Children - SEEDLING
A Phase 3 study testing budesonide/formoterol, budesonide and formoterol in people with Asthma, run by AstraZeneca.
Trial summary
The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in 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, budesonide and formoterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 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
- Baseline lung function tests results as determined by the protocol
- Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol
Who cannot join
- Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
- Has had cancer within previous 5 years or has a significant disease, as judged by investigator, that may put the patient at risk in this study
About this study
Official title: A 12 Week Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (40/4.5 Mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Asthmatic Children Aged Six to Eleven Years - SEEDLING 40/4.5
The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years
- Conditions
- Asthma
- Being tested
- budesonide/formoterol, budesonide, formoterol
- Keywords
- Asthma, Symbicort, budesonide/formoterol, budesonide, formoterol, children
- 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
budesonideDrug
formoterolDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: budesonide/formoterol |
| 2 | Active comparator | Not described Receives: Drug: budesonide |
| 3 | Active comparator | Not described Receives: Drug: formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning PEF
Measured: Daily
Secondary outcomes (1)
Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments
Measured: Throughout the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 405 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
- NCT00651547
- Sponsor's protocol ID
- SD-039-0718
- Other IDs
- D5896C00718
- Status last verified
- Mar 2009
- First submitted
- 1 Apr 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 12 Week Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (40/4.5 Mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Asthmatic Children Aged Six to Eleven Years - SEEDLING 40/4.5
- ClinicalTrials.gov ID
- NCT00651547
- Acronym / sponsor ID
- SD-039-0718
- Conditions
- Asthma
- Keywords
- Asthma, Symbicort, budesonide/formoterol, budesonide, formoterol, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- Oct 2003 (actual)
- First posted
- 3 Apr 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 Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: budesonide/formoterol |
| 2 | Active comparator | Drug: budesonide |
| 3 | Active comparator | Drug: formoterol |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Baseline lung function tests results as determined by the protocol
- Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol
Key exclusion criteria (3 listed)
- Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
- Has had cancer within previous 5 years or has a significant disease, as judged by investigator, 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/formoterolAlso: Symbicort | Drug | 1 |
| budesonide | Drug | 2 |
| formoterol | Drug | 3 |
Primary outcome
Morning PEF
Time frame: Daily
1 secondary outcome
Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments
Time frame: Throughout the 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, budesonide and formoterol 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 2 inclusion and 3 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?
Morning PEF (time frame: Daily). 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.