The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China
INITIAL
1 other identifier
observational
4,817
1 country
30
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
Typical duration for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedStudy Start
First participant enrolled
June 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2016
CompletedSeptember 15, 2017
September 1, 2017
2.3 years
May 19, 2014
September 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
evaluate the control level of initial 12 weeks treatment based on Assessment of Current Clinical Control in GINA (GINA 2012 update).
up to 3 months
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Participating in any clinical trial during the last 90 days
- Have COPD
- With asthma exacerbation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (30)
Research Site
Baotou, China
Research Site
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
Related Publications (7)
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.
PMID: 22932169BACKGROUNDRabe 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.
PMID: 11153575BACKGROUNDThompson 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.
PMID: 23730953BACKGROUNDZhao 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.
PMID: 23527968BACKGROUNDJuniper 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.
PMID: 10573240RESULTJuniper 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.
PMID: 11392570RESULTLin 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.
PMID: 30718519DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiangtao Lin, PhD
China-Japan Friendship Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2014
First Posted
May 21, 2014
Study Start
June 7, 2014
Primary Completion
September 15, 2016
Study Completion
September 15, 2016
Last Updated
September 15, 2017
Record last verified: 2017-09