AsthmaPhase 3NCT00652002
Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5
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 with formoterol alone in the treatment of asthma in adolescents and adults 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, budesonide and formoterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Jan 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least 12 years of age
- Diagnosis of asthma
- Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol 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
- 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 12 Week, Randomized, Double-blind, Double-dummy, Placebo-controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-products (Budesonide and Formoterol) in Adolescents (at Least 12 Years of Age) and Adults With Asthma - SPRUCE 160/4.5
The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults
- Conditions
- Asthma
- Being tested
- budesonide/formoterol, budesonide, formoterol
- Keywords
- Asthma, Symbicort, budesonide/formoterol, budesonide, formoterol
- 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 | budesonide Receives: Drug: budesonide |
| 3 | Active comparator | formoterol Receives: Drug: formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation
Measured: FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period
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 completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 450 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
- NCT00652002
- Sponsor's protocol ID
- SD-039-0717
- Other IDs
- D5896C00717
- Status last verified
- Jan 2011
- First submitted
- 1 Apr 2008
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Tashkin DP, Moore GE, Trudo F, DePietro M, Chipps BE. Assessment of Consistency of Fixed Airflow Obstruction Status during Budesonide/Formoterol Treatment and Its Effects on Treatment Outcomes in Patients with Asthma. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):705-12. doi: 10.1016/j.jaip.2016.02.014. Epub 2016 Mar 30.
PubMed 27039236Tashkin DP, Chipps BE, Trudo F, Zangrilli JG. Fixed airflow obstruction in asthma: a descriptive study of patient profiles and effect on treatment responses. J Asthma. 2014 Aug;51(6):603-9. doi: 10.3109/02770903.2014.895012. Epub 2014 Mar 19.
PubMed 24524222Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
PubMed 22329608
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, Placebo-controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-products (Budesonide and Formoterol) in Adolescents (at Least 12 Years of Age) and Adults With Asthma - SPRUCE 160/4.5
- ClinicalTrials.gov ID
- NCT00652002
- Acronym / sponsor ID
- SD-039-0717
- Conditions
- Asthma
- Keywords
- Asthma, Symbicort, budesonide/formoterol, budesonide, formoterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Study completion
- Jan 2004 (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 with formoterol alone in the treatment of asthma in adolescents and adults
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: budesonidebudesonide |
| 3 | Active comparator | Drug: formoterolformoterol |
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)
- At least 12 years of age
- Diagnosis of asthma
- Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol within the timeframe and doses specified in the protocol
Key exclusion criteria (2 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
- 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/formoterolAlso: Symbicort | Drug | 1 |
| budesonide | Drug | 2 |
| formoterol | Drug | 3 |
Primary outcome
12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation
Time frame: FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period
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 24 Jan 2011.
- Derived from this study: PubMed 27039236Tashkin DP, Moore GE, Trudo F, DePietro M, Chipps BE. Assessment of Consistency of Fixed Airflow Obstruction Status during Budesonide/Formoterol Treatment and Its Effects on Treatment Outcomes in Patients with Asthma. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):705-12. doi: 10.1016/j.jaip.2016.02.014. Epub 2016 Mar 30.
- Derived from this study: PubMed 24524222Tashkin DP, Chipps BE, Trudo F, Zangrilli JG. Fixed airflow obstruction in asthma: a descriptive study of patient profiles and effect on treatment responses. J Asthma. 2014 Aug;51(6):603-9. doi: 10.3109/02770903.2014.895012. Epub 2014 Mar 19.
- Derived from this study: PubMed 22329608Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
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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 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?
12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation (time frame: FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: 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 NCT00652002, which also lists 3 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 24 Jan 2011.