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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jiangtao Lin, PhD | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baotou | China | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22932169 | Background | 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. | |
| 11153575 | Background | Rabe 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. |
| Label | URL |
|---|---|
| 10573240 | View source |
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| Beijing |
| China |
| Research Site | Changsha | China |
| Research Site | Changshu | China |
| Research Site | Chengdu | China |
| Research Site | Chongqing | China |
| Research Site | Dalian | China |
| Research Site | Daping | China |
| Research Site | Fuzhou | China |
| Research Site | Guangyuan | China |
| Research Site | Guangzhou | China |
| Research Site | Harbin | China |
| Research Site | Hefei | China |
| Research Site | Hohhot | China |
| Research Site | Jining | China |
| Research Site | Kunming | China |
| Research Site | Mianyang | China |
| Research Site | Nantong | China |
| Research Site | Qingdao | China |
| Research Site | Shanghai | China |
| Research Site | Shenyang | China |
| Research Site | Shenzhen | China |
| Research Site | Shijiazhuang | China |
| Research Site | Suining | China |
| Research Site | Suzhou | China |
| Research Site | Taiyuan | China |
| Research Site | Tianjin | China |
| Research Site | Wuhan | China |
| Research Site | Xi'an | China |
| Research Site | Zhengzhou | China |
| 23730953 | Background | Thompson 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. |
| 23527968 | Background | Zhao 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. |
| 10573240 | Result | Juniper 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. |
| 11392570 | Result | Juniper 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. |
| 30718519 | Derived | Lin 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. |
| 11392570 | View source |
| 22932169 | View source |
| 11153575 | View source |
| 23730953 | View source |
| 23527968 | View source |
| CSR Synopsis | View source |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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