AsthmaPhase 3NCT00646321
Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT
A Phase 3 study testing budesonide/formoterol (Symbicort) and budesonide in people with Asthma, run by AstraZeneca.
Trial summary
The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- budesonide/formoterol (Symbicort) and budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Aug 2004
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At least 6 and maximally 15 years of age
- Diagnosis of asthma and baseline lung function tests as determined by the protocol
- Has required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol
Who cannot join
- Severe asthma
- Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
About this study
Official title: A 12 Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of SYMBICORT pMDI Administered Once Daily in Children and Adolescents 6 to 15 Years of Age With Asthma - SPROUT
The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years
- Conditions
- Asthma
- Being tested
- budesonide/formoterol (Symbicort), budesonide
- Keywords
- asthma, children, adolescents, Symbicort, budesonide/ formoterol, 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
budesonideDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | budesonide/formoterol Receives: Drug: budesonide/formoterol (Symbicort) |
| 2 | Active comparator | budesonide Receives: Drug: budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in evening PEF
Measured: Daily throughout the 12 week treatment period
Secondary outcomes (2)
Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes
Measured: Daily throughout the 12 week treatment period
Routine safety assessments described in the protocol
Measured: 2-4 assessments within 12 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 startApr 2003
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Double blind
- Enrolment
- 540 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
- NCT00646321
- Sponsor's protocol ID
- SD-039-0725
- Other IDs
- D5896C00725
- Status last verified
- Jan 2011
- First submitted
- 26 Mar 2008
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Eid NS, Noonan MJ, Chipps B, Parasuraman B, Miller CJ, O'Brien CD. Once- vs twice-daily budesonide/formoterol in 6- to 15-year-old patients with stable asthma. Pediatrics. 2010 Sep;126(3):e565-75. doi: 10.1542/peds.2009-2970. Epub 2010 Aug 16.
PubMed 20713475
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 12 Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of SYMBICORT pMDI Administered Once Daily in Children and Adolescents 6 to 15 Years of Age With Asthma - SPROUT
- ClinicalTrials.gov ID
- NCT00646321
- Acronym / sponsor ID
- SD-039-0725
- Conditions
- Asthma
- Keywords
- asthma, children, adolescents, Symbicort, budesonide/ formoterol, budesonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Aug 2004 (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 Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: budesonide/formoterol (Symbicort)budesonide/formoterol |
| 2 | Active comparator | Drug: budesonidebudesonide |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- At least 6 and maximally 15 years of age
- Diagnosis of asthma and baseline lung function tests as determined by the protocol
- Has required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol
Key exclusion criteria (2 listed)
- Severe asthma
- Has required treatment with any non-inhaled corticosteroids within 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/formoterol (Symbicort)Also: Symbicort | Drug | 1 |
| budesonide | Drug | 2 |
Primary outcome
Change in evening PEF
Time frame: Daily throughout the 12 week treatment period
2 secondary outcomes
Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes
Time frame: Daily throughout the 12 week treatment period
Routine safety assessments described in the protocol
Time frame: 2-4 assessments within 12 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 24 Jan 2011.
- Derived from this study: PubMed 20713475Eid NS, Noonan MJ, Chipps B, Parasuraman B, Miller CJ, O'Brien CD. Once- vs twice-daily budesonide/formoterol in 6- to 15-year-old patients with stable asthma. Pediatrics. 2010 Sep;126(3):e565-75. doi: 10.1542/peds.2009-2970. Epub 2010 Aug 16.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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.
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 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?
Change in evening PEF (time frame: Daily throughout the 12 week 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 NCT00646321, which also lists 1 linked publication.
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.