AsthmaNCT00784953
Real Life Effectiveness in Patients With Not Optimally Controlled Asthma
An observational study of Asthma, run by AstraZeneca at 6 sites in Taiwan.
Trial summary
A non-interventional study to explore actual asthma control status in real-life environment and to observe the efficacy after stepped-up to Symbicort SMART or various identical regimens. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- How many people
- 842 participants
- Where
- 6 sitesTaiwan
- Study dates
- Oct 2008to May 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Medical center
Who may be able to join
- Asthma patient who was partly controlled or uncontrolled by previous controllers of ICS only, or low dose ICS plus either LABA, leukotriene modifier or theophylline; or ICS- naïve with severe and persist symptom based on physician's judgment
- According to GINA guideline, who need to step up the controller medications, and ICS/LABA to be prescribed based on physician's discretion
Who cannot join
- Patients aged not within limitation refer to label information of various product prescribed
- Patients who have taken oral corticosteroids within 4 weeks prior to enrollment
- Patients with contraindications to prescribed medication
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Research Site
Changhua
Research Site
Kaohsiung City
Research Site
Keelung
Research Site
Taichung
Research Site
Tainan
Research Site
Taipei
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
A non-interventional study to explore actual asthma control status in real-life environment and to observe the efficacy after stepped-up to Symbicort SMART or various identical regimens.
The study will be implemented by screening asthmatic patients from respiratory clinics to identify those not optimally controlled and required stepping up the controllers to initiate, or to titrate dose of, ICS/LABA including Symbicort.
- Conditions
- Asthma
- Keywords
- Symbicort SMART, budesonide, formoterol, ICS/LABA, Asthma Control Questionnaire, Not optimally controlled asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Asthma patients who were partly controlled or uncontrolled, need to step up, or adjust dose of the controller medications to ICS/LABA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ACQ score from baseline to the mean of all available data from the follow up visits
Measured: wk 4±1; wk 12~16
Secondary outcomes (3)
Change in the individual asthma control status & pulmonary function from enrollment
Measured: wk 4±1; wk 12~16
Dose/usage of ICS/LABA and relievers & Patient compliance
Measured: wk 4±1; wk 12~16
Medical resource utilization
Measured: wk 4±1; wk 12~16; 6 month; 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2011
- Study completionMay 2011
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 842 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin Meng, MD, PhD, Study director, AstraZeneca TaiwanJia-Horng Wang, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784953
- Sponsor's protocol ID
- NIS-RTW-SYM-2008/1
- Status last verified
- Nov 2015
- First submitted
- 3 Nov 2008
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheng SL, Ho ML, Lai YF, Wang HC, Hsu JY, Liu SF, Huang MS, Lee CH, Lin CH, Hang LW, Liu YC, Yang KY, Wang JH. Budesonide/Formoterol Anti-Inflammatory Reliever and Maintenance or Fluticasone Propionate/Salmeterol Plus As-Needed, Short-Acting beta2 Agonist: Real-World Effectiveness in pAtients without Optimally Controlled asThma (REACT) Study. Drug Des Devel Ther. 2020 Dec 8;14:5441-5450. doi: 10.2147/DDDT.S266177. eCollection 2020.
PubMed 33324041
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. 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
- NCT00784953
- Acronym / sponsor ID
- NIS-RTW-SYM-2008/1
- Conditions
- Asthma
- Keywords
- Symbicort SMART, budesonide, formoterol, ICS/LABA, Asthma Control Questionnaire, Not optimally controlled asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 842 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 Nov 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.
A non-interventional study to explore actual asthma control status in real-life environment and to observe the efficacy after stepped-up to Symbicort SMART or various identical regimens.
The study will be implemented by screening asthmatic patients from respiratory clinics to identify those not optimally controlled and required stepping up the controllers to initiate, or to titrate dose of, ICS/LABA including Symbicort.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Asthma patients who were partly controlled or uncontrolled, need to step up, or adjust dose of the controller medications to ICS/LABA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Medical center
Key inclusion criteria (2 listed)
- Asthma patient who was partly controlled or uncontrolled by previous controllers of ICS only, or low dose ICS plus either LABA, leukotriene modifier or theophylline; or ICS- naïve with severe and persist symptom based on physician's judgment
- According to GINA guideline, who need to step up the controller medications, and ICS/LABA to be prescribed based on physician's discretion
Key exclusion criteria (3 listed)
- Patients aged not within limitation refer to label information of various product prescribed
- Patients who have taken oral corticosteroids within 4 weeks prior to enrollment
- Patients with contraindications to prescribed medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in ACQ score from baseline to the mean of all available data from the follow up visits
Time frame: wk 4±1; wk 12~16
3 secondary outcomes
Change in the individual asthma control status & pulmonary function from enrollment
Time frame: wk 4±1; wk 12~16
Dose/usage of ICS/LABA and relievers & Patient compliance
Time frame: wk 4±1; wk 12~16
Medical resource utilization
Time frame: wk 4±1; wk 12~16; 6 month; 12 month
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 10 Nov 2015.
- Derived from this study: PubMed 33324041Cheng SL, Ho ML, Lai YF, Wang HC, Hsu JY, Liu SF, Huang MS, Lee CH, Lin CH, Hang LW, Liu YC, Yang KY, Wang JH. Budesonide/Formoterol Anti-Inflammatory Reliever and Maintenance or Fluticasone Propionate/Salmeterol Plus As-Needed, Short-Acting beta2 Agonist: Real-World Effectiveness in pAtients without Optimally Controlled asThma (REACT) Study. Drug Des Devel Ther. 2020 Dec 8;14:5441-5450. doi: 10.2147/DDDT.S266177. eCollection 2020.
- CSR SynopsisLink provided by the sponsor.
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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.
Robin Meng, MD, PhD study director
AstraZeneca Taiwan
Jia-Horng Wang, MD principal investigator
Taipei Veterans General Hospital, Taiwan
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 6 sites in Taiwan.
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 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 ACQ score from baseline to the mean of all available data from the follow up visits (time frame: wk 4±1; wk 12~16). 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 NCT00784953, 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 10 Nov 2015.