AsthmaNCT01785901
The Asthma Control Rate Achieved by Budesonide/Formoterol in Clinical Practice in China
An observational study of Asthma, run by AstraZeneca at 11 sites in China.
Trial summary
This is a multi-centre, cross-sectional study planned to be conducted in China. The study aims to observe about 1500 asthma patients who have already received budesonide/formoterol combination treatment by physicians' determination and whose medications are aligned with the package insert of budesonide/formoterol… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- without interventions
- How many people
- 1,502 participants
- Where
- 11 sitesChina
- Study dates
- May 2013to Oct 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asthma patients from clinic
Who may be able to join
- Clinical diagnosis of asthma at least 6 months;
- Prescribed with budesonide/formoterol treatment at least 3 months before enrolled;
- Has used the same maintenance dose of budesonide/formoterol for at least 4 weeks before enrolled.
Who cannot join
- Participation in any clinical study within 3 months;
- Have COPD history/suspicious COPD;
- ≥ 10 pack years of smoking history
- Used any other asthma maintenance medication accompanied with budesonide/formoterol within 3 months before enrolled
- With asthma exacerbation (defined as asthma symptom deterioration resulting oral/rectal/parenteral GCS medication or emergency room treatment or hospitalisation) within 4 weeks before enrolled
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Research Site
Baotou, Inner Mongolia
Research Site
Beijing, Beijing Municipality
Research Site
Changsha, Hunan
Research Site
Chengdu, Sichuan
Research Site
Chongqing, Chongqing Municipality
Research Site
Guangzhou, Guangdong
Research site
Hangzhou, Zhejiang
Research Site
Harbin, Heilongjiang
Research Site
Nanjing, Jiangsu
Research Site
Qingdao, Shandong
Research Site
Wenzhou, Zhejiang
About this study
This is a multi-centre, cross-sectional study planned to be conducted in China. The study aims to observe about 1500 asthma patients who have already received budesonide/formoterol combination treatment by physicians' determination and whose medications are aligned with the package insert of budesonide/formoterol approved in China.
Read the detailed description
The asthma control rate achieved by budesonide/formoterol in clinical practice in China.
- Conditions
- Asthma
- Being tested
- without interventions
- Keywords
- asthma, control rate, budesonide/formoterol, Non-Interventional study
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without interventionsOther
without interventions
| Study group | Role | What they receive |
|---|---|---|
| Target subject population 1500 | Asthma patients who have already received the treatment of budesonide/formoterol by physicians' determination and whose medications are aligned with the package insert of budesonide/formoterol approved in China Receives: Other: without interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of controlled and partly controlled asthma according to the definition of Global Initiative for Asthma
Measured: one day
Secondary outcomes (2)
The rate of completely controlled and well controlled asthma according to Asthma Control Test's score
Measured: one day
The average frequency of reliever use in previous week
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785901
- Sponsor's protocol ID
- NIS-RCN-SYM-2012/1
- Status last verified
- Aug 2016
- First submitted
- 5 Feb 2013
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Makar AB, McMartin KE, Palese M, Tephly TR. Formate assay in body fluids: application in methanol poisoning. Biochem Med. 1975 Jun;13(2):117-26. doi: 10.1016/0006-2944(75)90147-7. No abstract available.
PubMed 1Lin J, Li J, Yu W, Liu Y, Liu C, Chen P, He H, He B, Liu S, Zhou X. A multicenter, cross-sectional, observational study of budesonide/formoterol maintenance and reliever therapy in real-world settings. Respir Med. 2017 Jun;127:45-50. doi: 10.1016/j.rmed.2017.04.004. Epub 2017 Apr 6.
PubMed 28502418
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Asthma Control Rate Achieved by Budesonide/Formoterol in Clinical Practice in China
- ClinicalTrials.gov ID
- NCT01785901
- Acronym / sponsor ID
- NIS-RCN-SYM-2012/1
- Conditions
- Asthma
- Keywords
- asthma, control rate, budesonide/formoterol, Non-Interventional study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,502 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Feb 2013 (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.
This is a multi-centre, cross-sectional study planned to be conducted in China. The study aims to observe about 1500 asthma patients who have already received budesonide/formoterol combination treatment by physicians' determination and whose medications are aligned with the package insert of budesonide/formoterol approved in China.
Detailed description
The asthma control rate achieved by budesonide/formoterol in clinical practice in China.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Target subject population 1500 | – | Other: without interventionsAsthma patients who have already received the treatment of budesonide/formoterol by physicians' determination and whose medications are aligned with the package insert of budesonide/formoterol approved in China |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asthma patients from clinic
Key inclusion criteria (3 listed)
- Clinical diagnosis of asthma at least 6 months;
- Prescribed with budesonide/formoterol treatment at least 3 months before enrolled;
- Has used the same maintenance dose of budesonide/formoterol for at least 4 weeks before enrolled.
Key exclusion criteria (5 listed)
- Participation in any clinical study within 3 months;
- Have COPD history/suspicious COPD;
- ≥ 10 pack years of smoking history
- Used any other asthma maintenance medication accompanied with budesonide/formoterol within 3 months before enrolled
- With asthma exacerbation (defined as asthma symptom deterioration resulting oral/rectal/parenteral GCS medication or emergency room treatment or hospitalisation) within 4 weeks before enrolled
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 |
|---|---|---|
| without interventionswithout interventions | Other | Target subject population 1500 |
Primary outcome
The rate of controlled and partly controlled asthma according to the definition of Global Initiative for Asthma
Time frame: one day
2 secondary outcomes
The rate of completely controlled and well controlled asthma according to Asthma Control Test's score
Time frame: one day
The average frequency of reliever use in previous week
Time frame: one day
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 19 Aug 2016.
- Background: PubMed 1Makar AB, McMartin KE, Palese M, Tephly TR. Formate assay in body fluids: application in methanol poisoning. Biochem Med. 1975 Jun;13(2):117-26. doi: 10.1016/0006-2944(75)90147-7. No abstract available.
- Derived from this study: PubMed 28502418Lin J, Li J, Yu W, Liu Y, Liu C, Chen P, He H, He B, Liu S, Zhou X. A multicenter, cross-sectional, observational study of budesonide/formoterol maintenance and reliever therapy in real-world settings. Respir Med. 2017 Jun;127:45-50. doi: 10.1016/j.rmed.2017.04.004. Epub 2017 Apr 6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
11 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 11 sites in China.
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 5 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 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. 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?
The rate of controlled and partly controlled asthma according to the definition of Global Initiative for Asthma (time frame: one day). 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 NCT01785901, 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 19 Aug 2016.