AsthmaPhase 4SMARTASIANCT00939341
Study to Investigate Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma Patients Across Asia
A Phase 4 study testing Symbicort (Budesonide/Formoterol) in people with Asthma, run by AstraZeneca at 35 sites in 5 countries.
Trial summary
The purpose of this study is to compare whether Symbicort Maintenance \& Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Symbicort (Budesonide/Formoterol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 862 participants
- Where
- 35 sitesin 5 countries
- Study dates
- Jul 2009to Aug 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed informed consent
- Asthma diagnosis at least 6 months before visit 1 of study
- Patients who have reversible airway obstruction continuous asthma treatment except Symbicort at least within 4 weeks before visit 1 of study
Who cannot join
- Known or suspected allergy to active ingredients of study medication or excipients
- Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study
- Smoking, current or previous with a smoking history of ≥ 10 pack years
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
China13 sites
Research Site
Beijing
Research Site
Changsha, Hunan
Research Site
Chengdu
Research Site
Fuzhou
Research Site
Guangzhou, Guangdong
Research Site
Hangzhou
Research Site
Nanjing
Research Site
Qingdao, Shandong
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang
Research Site
Wuhan, Hubei
Research Site
Zheng Ahou, Henan
Research Site
Zhengzhou
India10 sites
Research Site
Ahmedabad, Gujarat
Research Site
Bangalore, Karnataka
Research Site
Bengaluru, Karnataka
Research Site
Chennai, Tamil Nadu
Research Site
Coimbatore, Tamil Nadu
Research Site
Hyderabad, Andhra Pradesh
Research Site
Indore, Madhya Pradesh
Research Site
Lucknow, Uttar Pradesh
Research Site
Mumbai, Maharashtra
Research Site
Noida, Uttar Pradesh
Taiwan6 sites
Research Site
Chiayi City
Research Site
Hsinchu
Research Site
Kaohsiung City
Research Site
Taichung
Research Site
Taipei
Research Site
Taoyuan City
Thailand4 sites
Research Site
Bangkok, Bangkok
Research Site
Nakhonratchasima, Naimuang
Research Site
Pathum Thani, Changwat Pathum Thani
Research Site
Pathumwan, Bangkok
Indonesia2 sites
Research Site
Jakarta, DKI Jakarta
Research Site
Surabaya, East Java
About this study
Official title: Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients Across Asia: SMARTASIA
The purpose of this study is to compare whether Symbicort Maintenance \& Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.
- Conditions
- Asthma
- Being tested
- Symbicort (Budesonide/Formoterol)
- Keywords
- Symbicort SMART
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbicort (Budesonide/Formoterol)Drug
Also called Symbicort
Turbuhaler 160/4.5 µg delivered dose, twice daily (one inhalation in the morning and one inhalation in the evening) and as need (prn) in response to symptoms
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Symbicort Turbuhaler 160/4.5 µg delivered dose Receives: Drug: Symbicort (Budesonide/Formoterol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Measured: Baseline and 12 weeks
Secondary outcomes (16)
Change in ACQ(5) Score From Baseline at Country Level (China)
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Measured: Baseline and 12 weeks
Change in Overall ACQ(5) Score From Baseline at Country Level (India)
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Measured: Baseline and 12 weeks
Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Measured: Baseline and 12 weeks
Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Measured: Baseline and 12 weeks
Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Measured: Baseline and 12 weeks
Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline
Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)
Measured: Baseline and 12 weeks
Change in AQLQ (S) Domain (Symptom) Scores From Baseline
Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
Measured: Baseline and 12 weeks
Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline
Participants' QOL were scored on a scale of decreasing QOL impairment from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) symptom score from baseline were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)
Measured: Baseline and 12 weeks
Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline
Participants' emotional functions were scored on a scale of decreasing impairment to emotional function from 1 to 7, in which 1 = maximum impairment. The change in overall mean AQLQ(S) emotion function score were calculated as change from baseline (Week 0) to the treatment period (mean of the scores at Week 4, Week 8, Week 12)
Measured: Baseline and 12 weeks
Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline
Participants ' responses to environmental stimuli were scored on a scale of decreasing response to environmental stimuli from 1 to 7, in which 1 = maximum response. The change in overall mean AQLQ(S) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12)
Measured: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period
Change in the number of as-needed day-time inhalations of medication, defined as the difference in mean value of all available data obtained during treatment period and mean value in run-in period.
Measured: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period
Change in the number of as-needed night-time inhalations of medication, calculated as difference in mean value of all available data obtained during treatment period and mean value in run-in period.
Measured: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period
Total number of inhalations of Symbicort® 160µg/4.5µg per day during treatment period, defined as the sum of maintenance medication and as-needed medication during night and day time
Measured: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 3 Inhalations of Symbicort® 160µg/4.5µg in a Day
The mean percentage of days during treatment period participants used ≥ 3 inhalations of Symbicort® 160µg/4.5µg in a day
Measured: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day
The mean percentage of days during treatment period participants used ≥ 5 inhalations of Symbicort® 160µg/4.5µg in a day
Measured: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 9 Inhalations of Symbicort® 160µg/4.5µg in a Day
The mean percentage of days during treatment period participants used ≥ 9 inhalations of Symbicort® 160µg/4.5µg in a day
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 862 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guy Yeoman, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939341
- Sponsor's protocol ID
- D5890L00035
- Acronym
- SMARTASIA
- Status last verified
- Jan 2012
- First submitted
- 13 Jul 2009
- Last updated
- 16 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lin J, Tang Y, Xiu Q, Kang J, Cai S, Huang K, Itoh Y, Ling X, Zhong N. Real-life effectiveness of budesonide/formoterol therapy in asthma: A subanalysis of the SMARTASIA study. Allergy Asthma Proc. 2016 Jan-Feb;37(1):27-34. doi: 10.2500/aap.2016.37.3910.
PubMed 26831844Zhong N, Lin J, Mehta P, Ngamjanyaporn P, Wu TC, Yunus F. Real-life effectiveness of budesonide/formoterol maintenance and reliever therapy in asthma patients across Asia: SMARTASIA study. BMC Pulm Med. 2013 Apr 4;13:22. doi: 10.1186/1471-2466-13-22.
PubMed 23557023
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Effectiveness of Symbicort Maintenance and Reliever Therapy (SMART) in Asthma Patients Across Asia: SMARTASIA
- ClinicalTrials.gov ID
- NCT00939341
- Acronym / sponsor ID
- SMARTASIA / D5890L00035
- Conditions
- Asthma
- Keywords
- Symbicort SMART
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 862 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 15 Jul 2009 (estimated)
- Results
- Posted 28 Nov 2011
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 whether Symbicort Maintenance \& Reliever Therapy (SMART) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Symbicort (Budesonide/Formoterol)Symbicort Turbuhaler 160/4.5 µg delivered dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of signed informed consent
- Asthma diagnosis at least 6 months before visit 1 of study
- Patients who have reversible airway obstruction continuous asthma treatment except Symbicort at least within 4 weeks before visit 1 of study
Key exclusion criteria (3 listed)
- Known or suspected allergy to active ingredients of study medication or excipients
- Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study
- Smoking, current or previous with a smoking history of ≥ 10 pack years
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 |
|---|---|---|
| Symbicort (Budesonide/Formoterol)Also: SymbicortTurbuhaler 160/4.5 µg delivered dose, twice daily (one inhalation in the morning and one inhalation in the evening) and as need (prn) in response to symptoms | Drug | 1 |
Primary outcome
Change in Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level
Time frame: Baseline and 12 weeks
Participants' levels of asthma control were scored on a 7-point Likert scale from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The regional mean change of overall ACQ(5) score were calculated as change from baseline (Week 0) to the average during the treatment period (mean of scores at Week 4, Week 8, Week 12).
16 secondary outcomes
Change in ACQ(5) Score From Baseline at Country Level (China)
Time frame: Baseline and 12 weeks
Change in Overall ACQ(5) Score From Baseline at Country Level (India)
Time frame: Baseline and 12 weeks
Change in Overall ACQ(5) Score From Baseline at Country Level (Indonesia)
Time frame: Baseline and 12 weeks
Change in Overall ACQ(5) Score From Baseline at Country Level (Taiwan)
Time frame: Baseline and 12 weeks
Change in Overall ACQ(5) Score From Baseline at Country Level (Thailand)
Time frame: Baseline and 12 weeks
Change in Asthma Quality of Life Questionnaire, Standardized Version (AQLQ (S)) Overall Scores From Baseline
Time frame: Baseline and 12 weeks
Change in AQLQ (S) Domain (Symptom) Scores From Baseline
Time frame: Baseline and 12 weeks
Change in AQLQ (S) Domain (Activity Limitation) Scores From Baseline
Time frame: Baseline and 12 weeks
Change in AQLQ (S) Domain (Emotion Function) Scores From Baseline
Time frame: Baseline and 12 weeks
Change in AQLQ (S) Domain (Environmental Stimuli) Scores From Baseline
Time frame: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Day-time Reliever Medication From run-in Period
Time frame: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Change in As-needed Night-time Reliever Medication From run-in Period
Time frame: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Total Number of Inhalations of Symbicort® 160µg/4.5µg Per Day During Treatment Period
Time frame: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 3 Inhalations of Symbicort® 160µg/4.5µg in a Day
Time frame: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 5 Inhalations of of Symbicort® 160µg/4.5µg in a Day
Time frame: Baseline and 12 weeks
Study Medication Use (Maintenance and Reliever) in Diary Cards - Percentage of Days During Treatment Period Participants Used ≥ 9 Inhalations of Symbicort® 160µg/4.5µg in a Day
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26831844Lin J, Tang Y, Xiu Q, Kang J, Cai S, Huang K, Itoh Y, Ling X, Zhong N. Real-life effectiveness of budesonide/formoterol therapy in asthma: A subanalysis of the SMARTASIA study. Allergy Asthma Proc. 2016 Jan-Feb;37(1):27-34. doi: 10.2500/aap.2016.37.3910.
- Derived from this study: PubMed 23557023Zhong N, Lin J, Mehta P, Ngamjanyaporn P, Wu TC, Yunus F. Real-life effectiveness of budesonide/formoterol maintenance and reliever therapy in asthma patients across Asia: SMARTASIA study. BMC Pulm Med. 2013 Apr 4;13:22. doi: 10.1186/1471-2466-13-22.
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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.
Guy Yeoman, MD study director
AstraZeneca
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Symbicort (Budesonide/Formoterol) in people with Asthma, run by AstraZeneca at 35 sites in 5 countries.
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 16 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in China, India, Taiwan, Thailand, Indonesia. 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.
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?
Yes. Results are posted in the registry (first posted 28 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Asthma Control Questionnaire (ACQ(5)) Score From Baseline at a Regional Level (time frame: Baseline and 12 weeks). 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 NCT00939341, which also lists 2 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 16 Jan 2012.