Clinical trial NCT02143739: The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China
Official title: The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 4817
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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).

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).

Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed asthma patients who are not on inhaled gluococorticosteroid within 3 months.
2. Out-patient with an age of 18 years and above
3. 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.

Exclusion Criteria:

1. Participating in any clinical trial during the last 90 days
2. Have COPD
3. With asthma exacerbation

Primary outcomes:
measure: Asthma Severity assessment based on GINA definition (GINA 2006 update) at baseline in the total population
timeFrame: Day 1
Secondary outcomes:
measure: evaluate the control level of initial 12 weeks treatment based on Assessment of Current Clinical Control in GINA (GINA 2012 update).
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Baotou
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Changshu
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Dalian
country: China
facility: Research Site
city: Daping
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangyuan
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Harbin
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Huhehaote
country: China
facility: Research Site
city: Jining
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Mianyang
country: China
facility: Research Site
city: Nantong
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: ShenZhen
country: China
facility: Research Site
city: Shijiazhuang
country: China
facility: Research Site
city: Suining
country: China
facility: Research Site
city: Suzhou
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
Study officials:
affiliation: China-Japan Friendship Hospital
name: Jiangtao Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.