AsthmaINITIALNCT02143739
The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China
An observational study of Asthma, run by AstraZeneca at 30 sites in China.
Trial summary
The primary objective of the NIS is to evaluate the severity of newly diagnosed asthma patients based on Global Initiative for Asthma (GINA) severity category (GINA 2006 update). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 4,817 participants
- Where
- 30 sitesChina
- Study dates
- 7 Jun 2014to 15 Sep 2016
- How long will I take part?
- 12 Weeks
- 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: The patient population will be outpatients, men or women, ≥18 years of age, Newly diagnosed asthma patients who are not on inhaled gluococorticosteroid within 3 months.The patient population should not have COPD history, or asthma exacerbation.
Who may be able to join
- Newly diagnosed asthma patients who are not on inhaled gluococorticosteroid within 3 months.
- Out-patient with an age of 18 years and above
- Signed and dated informed consent The prescription of the medicinal product is clearly separated from the decision to include the subject in the NIS. Generally, asthma medication refers to those recommended in GINA guideline (GINA2012 update) and decided by investigator.
Who cannot join
- Participating in any clinical trial during the last 90 days
- Have COPD
- With asthma exacerbation
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
China30 sites
Research Site
Baotou
Research Site
Beijing
Research Site
Changsha
Research Site
Changshu
Research Site
Chengdu
Research Site
Chongqing
Research Site
Dalian
Research Site
Daping
Research Site
Fuzhou
Research Site
Guangyuan
Research Site
Guangzhou
Research Site
Harbin
Research Site
Hefei
Research Site
Hohhot
Research Site
Jining
Research Site
Kunming
Research Site
Mianyang
Research Site
Nantong
Research Site
Qingdao
Research Site
Shanghai
Research Site
Shenyang
Research Site
Shenzhen
Research Site
Shijiazhuang
Research Site
Suining
Research Site
Suzhou
Research Site
Taiyuan
Research Site
Tianjin
Research Site
Wuhan
Research Site
Xi'an
Research Site
Zhengzhou
About this study
Official title: The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China.
The primary objective of the NIS is to evaluate the severity of newly diagnosed asthma patients based on Global Initiative for Asthma (GINA) severity category (GINA 2006 update).
Read the detailed description
This is a multi-centre, prospective non-interventional study planned to be conducted in China. The study aims to recruit about 5000 newly diagnosed patients from about 50 tier 3 hospitals with respiratory department. Each site recruits about 50-150 patients.
The primary variable will be distribution of severity based on GINA definition (GINA 2006 update) at baseline in the total population.
There will be 4 visits for this study, Informed consent and following study procedures (ACQ-5(asthma control questionnaire), severity assessment) will be done at visit 1. After that, according to clinical practice in China patients usually go to the clinic every 4 weeks. Asthma control status, ACQ-5 and sever exacerbation will be assessed at each clinic visit till 12 weeks (visit 2, 3, 4).
- Conditions
- Asthma
- Keywords
- 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 |
|---|---|---|
| Newly diagnosed asthma patients | The patient population will be outpatients, men or women, ≥18 years of age, Newly diagnosed asthma patients who are not on inhaled gluococorticosteroid within 3 months.The patient population should not have COPD(chronic obstructive pulmonary diseases) history, or asthma exacerbation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Severity assessment based on GINA definition (GINA 2006 update) at baseline in the total population
severity based on GINA definition (GINA 2006 update) at baseline in the total population.
Measured: Day 1
Secondary outcomes (1)
evaluate the control level of initial 12 weeks treatment based on Assessment of Current Clinical Control in GINA (GINA 2012 update).
The asthma control status assessment will be based on Assessment of Current Clinical Control in GINA (GINA 2012 update).
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study start7 Jun 2014
- Primary completion15 Sep 2016
- Study completion15 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Other
- Time perspective
- Prospective
- Enrolment
- 4,817 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiangtao Lin, PhD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143739
- Sponsor's protocol ID
- NIS-RCN-XXX-2013/2
- Acronym
- INITIAL
- Status last verified
- Sep 2017
- First submitted
- 19 May 2014
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lin JT, Chen P, Zhou X, Sun TY, Xie CM, Xiu QY, Yao WZ, Yang L, Yin KS, Zhang YM. Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma. Chin Med J (Engl). 2012 Sep;125(17):2994-3001.
PubMed 22932169Rabe KF, Vermeire PA, Soriano JB, Maier WC. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Respir J. 2000 Nov;16(5):802-7. doi: 10.1183/09031936.00.16580200.
PubMed 11153575Thompson PJ, Salvi S, Lin J, Cho YJ, Eng P, Abdul Manap R, Boonsawat W, Hsu JY, Faruqi RA, Moreno-Cantu JJ, Fish JE, Ho JC. Insights, attitudes and perceptions about asthma and its treatment: findings from a multinational survey of patients from 8 Asia-Pacific countries and Hong Kong. Respirology. 2013 Aug;18(6):957-67. doi: 10.1111/resp.12137.
PubMed 23730953Zhao J; National Parents of Asthmatic Children KAP Project Team. [Asthma control status in children and related factors in 29 cities of China]. Zhonghua Er Ke Za Zhi. 2013 Feb;51(2):90-5. Chinese.
PubMed 23527968Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
PubMed 10573240Juniper EF, O'Byrne PM, Roberts JN. Measuring asthma control in group studies: do we need airway calibre and rescue beta2-agonist use? Respir Med. 2001 May;95(5):319-23. doi: 10.1053/rmed.2001.1034.
PubMed 11392570Lin J, Fu X, Jiang P, Song W, Hu X, Jie Z, Liu C, He Z, Zhou X, Tang H. INITIAL - An observational study of disease severity in newly diagnosed asthma patients and initial response following 12 weeks' treatment. Sci Rep. 2019 Feb 4;9(1):1254. doi: 10.1038/s41598-018-36611-w.
PubMed 30718519
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China.
- ClinicalTrials.gov ID
- NCT02143739
- Acronym / sponsor ID
- INITIAL / NIS-RCN-XXX-2013/2
- Conditions
- Asthma
- Keywords
- asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,817 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2014 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 15 Sep 2016 (actual)
- First posted
- 21 May 2014 (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 primary objective of the NIS is to evaluate the severity of newly diagnosed asthma patients based on Global Initiative for Asthma (GINA) severity category (GINA 2006 update).
Detailed description
This is a multi-centre, prospective non-interventional study planned to be conducted in China. The study aims to recruit about 5000 newly diagnosed patients from about 50 tier 3 hospitals with respiratory department. Each site recruits about 50-150 patients.
The primary variable will be distribution of severity based on GINA definition (GINA 2006 update) at baseline in the total population.
There will be 4 visits for this study, Informed consent and following study procedures (ACQ-5(asthma control questionnaire), severity assessment) will be done at visit 1. After that, according to clinical practice in China patients usually go to the clinic every 4 weeks. Asthma control status, ACQ-5 and sever exacerbation will be assessed at each clinic visit till 12 weeks (visit 2, 3, 4).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed asthma patients | – | –The patient population will be outpatients, men or women, ≥18 years of age, Newly diagnosed asthma patients who are not on inhaled gluococorticosteroid within 3 months.The patient population should not have COPD(chronic obstructive pulmonary diseases) history, or asthma exacerbation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population will be outpatients, men or women, ≥18 years of age, Newly diagnosed asthma patients who are not on inhaled gluococorticosteroid within 3 months.The patient population should not have COPD history, or asthma exacerbation.
Key inclusion criteria (3 listed)
- Newly diagnosed asthma patients who are not on inhaled gluococorticosteroid within 3 months.
- Out-patient with an age of 18 years and above
- Signed and dated informed consent The prescription of the medicinal product is clearly separated from the decision to include the subject in the NIS. Generally, asthma medication refers to those recommended in GINA guideline (GINA2012 update) and decided by investigator.
Key exclusion criteria (3 listed)
- Participating in any clinical trial during the last 90 days
- Have COPD
- With asthma exacerbation
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
Asthma Severity assessment based on GINA definition (GINA 2006 update) at baseline in the total population
Time frame: Day 1
severity based on GINA definition (GINA 2006 update) at baseline in the total population.
1 secondary outcome
evaluate the control level of initial 12 weeks treatment based on Assessment of Current Clinical Control in GINA (GINA 2012 update).
Time frame: up to 3 months
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 15 Sep 2017.
- Background: PubMed 22932169Lin JT, Chen P, Zhou X, Sun TY, Xie CM, Xiu QY, Yao WZ, Yang L, Yin KS, Zhang YM. Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma. Chin Med J (Engl). 2012 Sep;125(17):2994-3001.
- Background: PubMed 11153575Rabe KF, Vermeire PA, Soriano JB, Maier WC. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Respir J. 2000 Nov;16(5):802-7. doi: 10.1183/09031936.00.16580200.
- Background: PubMed 23730953Thompson PJ, Salvi S, Lin J, Cho YJ, Eng P, Abdul Manap R, Boonsawat W, Hsu JY, Faruqi RA, Moreno-Cantu JJ, Fish JE, Ho JC. Insights, attitudes and perceptions about asthma and its treatment: findings from a multinational survey of patients from 8 Asia-Pacific countries and Hong Kong. Respirology. 2013 Aug;18(6):957-67. doi: 10.1111/resp.12137.
- Background: PubMed 23527968Zhao J; National Parents of Asthmatic Children KAP Project Team. [Asthma control status in children and related factors in 29 cities of China]. Zhonghua Er Ke Za Zhi. 2013 Feb;51(2):90-5. Chinese.
- Results publication: PubMed 10573240Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
- Results publication: PubMed 11392570Juniper EF, O'Byrne PM, Roberts JN. Measuring asthma control in group studies: do we need airway calibre and rescue beta2-agonist use? Respir Med. 2001 May;95(5):319-23. doi: 10.1053/rmed.2001.1034.
- Derived from this study: PubMed 30718519Lin J, Fu X, Jiang P, Song W, Hu X, Jie Z, Liu C, He Z, Zhou X, Tang H. INITIAL - An observational study of disease severity in newly diagnosed asthma patients and initial response following 12 weeks' treatment. Sci Rep. 2019 Feb 4;9(1):1254. doi: 10.1038/s41598-018-36611-w.
- 10573240Link provided by the sponsor.
- 11392570Link provided by the sponsor.
- 22932169Link provided by the sponsor.
- 11153575Link provided by the sponsor.
- 23730953Link provided by the sponsor.
- 23527968Link 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.
Jiangtao Lin, PhD principal investigator
China-Japan Friendship Hospital
30 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 30 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 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 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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?
Asthma Severity assessment based on GINA definition (GINA 2006 update) at baseline in the total population (time frame: Day 1). 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 NCT02143739, which also lists 7 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 15 Sep 2017.