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NCT02143739 Clinical Trial

The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China

Asthma Clinical Trial

— INITIAL  

Official title:
The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02143739
Other study ID # NIS-RCN-XXX-2013/2
Secondary ID
Status Completed
Phase N/A
First received May 19, 2014
Last updated September 14, 2017
Start date June 7, 2014
Est. completion date September 15, 2016

Study information
Verified date September 2017
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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).

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).

Recruitment information / eligibility
Status Completed
Enrollment 4817
Est. completion date September 15, 2016
Est. primary completion date September 15, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China 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 Huhehaote
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 Xian
China Research Site Zhengzhou

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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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