AsthmaPhase 4NCT01647646
Real Life Effectiveness in Patients With Not Optimally Controlled Asthma
A Phase 4 study testing Seretide in people with Asthma, run by Far Eastern Memorial Hospital.
Trial summary
In real life, the investigators will be using different strategies including SMART therapy or other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Seretide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Mar 2012
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- asthma not well control
Who cannot join
- COPD
About this study
Official title: Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA
In real life, the investigators will be using different strategies including SMART therapy or other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.
Read the detailed description
- All not-well controlled asthma patients would include the study.
- We will compare three ways of asthma control including SMART, fixed doses with regular doses and fixed doses with higher doses
- We will evaluate the efficacy/safety for these not-well controlled patients.
- Conditions
- Asthma
- Being tested
- Seretide
- Keywords
- asthma, SMART, fixed dose
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeretideDrug
Also called Symbicort compared with Seretide
Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety
| Study group | Role | What they receive |
|---|---|---|
| Symbicort | Active comparator | We will evaluate the efficacy fot Symbicort use. The usage was 2 doses bid for one year period.
Intervention drug: Seretide fixed doses therapy Receives: Drug: Seretide |
| Seretide | Experimental | In non-well asthma controlled patients, experimental study with Seretide regular doses (125 2 doses bid for one year) and higher doses (250 2 doses bid) for one year Receives: Drug: Seretide |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of asthma total and well control
F/U clinical asthma control status and percentage of Acute exacerbation
Measured: one year
Secondary outcomes (1)
percentage of asthma acute exacerbation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startMar 2009
- Primary completionFeb 2011
- Study completionMar 2012
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shih-Lung Cheng, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647646
- Sponsor's protocol ID
- 97083
- Status last verified
- Jul 2012
- First submitted
- 19 Jul 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA
- ClinicalTrials.gov ID
- NCT01647646
- Acronym / sponsor ID
- 97083
- Conditions
- Asthma
- Keywords
- asthma, SMART, fixed dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 Jul 2012 (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.
In real life, the investigators will be using different strategies including SMART therapy or other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.
Detailed description
- All not-well controlled asthma patients would include the study.
- We will compare three ways of asthma control including SMART, fixed doses with regular doses and fixed doses with higher doses
- We will evaluate the efficacy/safety for these not-well controlled patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbicort | Active comparator | Drug: SeretideWe will evaluate the efficacy fot Symbicort use. The usage was 2 doses bid for one year period. Intervention drug: Seretide fixed doses therapy |
| Seretide | Experimental | Drug: SeretideIn non-well asthma controlled patients, experimental study with Seretide regular doses (125 2 doses bid for one year) and higher doses (250 2 doses bid) for one year |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- asthma not well control
Key exclusion criteria (1 listed)
- COPD
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 |
|---|---|---|
| SeretideAlso: Symbicort compared with SeretideUsing Symbicort and Seretide for asthma control measurements Compared with efficacy and safety | Drug | Seretide, Symbicort |
Primary outcome
the percentage of asthma total and well control
Time frame: one year
F/U clinical asthma control status and percentage of Acute exacerbation
1 secondary outcome
percentage of asthma acute exacerbation
Time frame: one year
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 Jul 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Seretide in people with Asthma, run by Far Eastern Memorial Hospital.
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 1 inclusion and 1 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 Jul 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the percentage of asthma total and well control (time frame: one year). 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 24 Jul 2012.