Mild or Moderate AsthmaPhase 3NCT00646516
Gemini Symbicort pMDI
A Phase 3 study testing budesonide/formoterol (Symbicort) in people with Mild or Moderate Asthma, run by AstraZeneca.
Trial summary
The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Mild or Moderate Asthma
- What is being tested?
- budesonide/formoterol (Symbicort)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 615 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Feb 2005
- 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
- Diagnosis of asthma
- Baseline lung function tests as determined by protocol.
- Required and received treatment with inhaled corticosteroids and/or lung treatments specified in the protocol within timeframe and doses specified in protocol.
Who cannot join
- Severe asthma
- Has required treatment with any non-inhaled corticosteroid 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 Rand, Doubleblind, Activecontrolled, Parallel-grp,Singledummy, Multicenter,12 wk Study to Assess the Effic.&Safety of Symbicort pMDI 2x160/4.5mcg QD Compared to Symb. pMDI 2x80/4.5mcg QD, Symb. pMDI 2x80/4.5mcg Bid and to Budesonide pMDI 2x160 Mcg QD in Asthmatic Sub's12yrs and Over
The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.
- Conditions
- Mild or Moderate Asthma
- Being tested
- budesonide/formoterol (Symbicort)
- Keywords
- Asthma, inhaled corticosteroids, Symbicort, budesonide/formoterol, budesonide
- Medical subject headings
- Lymphoma, Follicular, 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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: budesonide/formoterol (Symbicort) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from start of treatment in evening pre-dose FEV1
Measured: 2, 6 and 12 weeks after starting treatment
Secondary outcomes (2)
Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes
Measured: Daily
Investigate safety profile of Symbicort and budesonide
Measured: Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment
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 startOct 2003
- Study completionFeb 2005
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 Mild or Moderate 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
- 615 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Liza O'Dowd, MD, Study director, AstraZenecaCatherine Bonuccelli, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646516
- Sponsor's protocol ID
- D5896C00001
- Status last verified
- Jan 2011
- First submitted
- 26 Mar 2008
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kerwin EM, Oppenheimer JJ, LaForce C, Parasuraman B, Miller CJ, O'Dowd L, Goldman M. Efficacy and tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler in adults and adolescents with asthma previously stable with twice-daily budesonide/ formoterol dosing. Ann Allergy Asthma Immunol. 2009 Jul;103(1):62-72. doi: 10.1016/S1081-1206(10)60145-7.
PubMed 19663129
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 Rand, Doubleblind, Activecontrolled, Parallel-grp,Singledummy, Multicenter,12 wk Study to Assess the Effic.&Safety of Symbicort pMDI 2x160/4.5mcg QD Compared to Symb. pMDI 2x80/4.5mcg QD, Symb. pMDI 2x80/4.5mcg Bid and to Budesonide pMDI 2x160 Mcg QD in Asthmatic Sub's12yrs and Over
- ClinicalTrials.gov ID
- NCT00646516
- Acronym / sponsor ID
- D5896C00001
- Conditions
- Mild or Moderate Asthma
- Keywords
- Asthma, inhaled corticosteroids, Symbicort, budesonide/formoterol, budesonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Feb 2005 (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 determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: budesonide/formoterol (Symbicort) |
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)
- Diagnosis of asthma
- Baseline lung function tests as determined by protocol.
- Required and received treatment with inhaled corticosteroids and/or lung treatments specified in the protocol within timeframe and doses specified in protocol.
Key exclusion criteria (3 listed)
- Severe asthma
- Has required treatment with any non-inhaled corticosteroid 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/formoterol (Symbicort)Also: Symbicort | Drug | 1 |
Primary outcome
Change from start of treatment in evening pre-dose FEV1
Time frame: 2, 6 and 12 weeks after starting treatment
2 secondary outcomes
Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes
Time frame: Daily
Investigate safety profile of Symbicort and budesonide
Time frame: Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment
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 19663129Kerwin EM, Oppenheimer JJ, LaForce C, Parasuraman B, Miller CJ, O'Dowd L, Goldman M. Efficacy and tolerability of once-daily budesonide/formoterol pressurized metered-dose inhaler in adults and adolescents with asthma previously stable with twice-daily budesonide/ formoterol dosing. Ann Allergy Asthma Immunol. 2009 Jul;103(1):62-72. doi: 10.1016/S1081-1206(10)60145-7.
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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.
Liza O'Dowd, MD study director
AstraZeneca
Catherine Bonuccelli study chair
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing budesonide/formoterol (Symbicort) in people with Mild or Moderate 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 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 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 from start of treatment in evening pre-dose FEV1 (time frame: 2, 6 and 12 weeks after starting treatment). 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 NCT00646516, 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.