Agricultural Health Study Follow-up
NCT01399411
Asthma, Autoimmune Diseases
Iowa City, Illinois, United States
View Trial DetailsNCT Number: NCT02143739
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).
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Notify Me18 year and older
All sexes
Observational
Research Site, Baotou, China
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 1
severity based on GINA definition (GINA 2006 update) at baseline in the total population.
Time frame: up to 3 months
The asthma control status assessment will be based on Assessment of Current Clinical Control in GINA (GINA 2012 update).
AstraZeneca
Industry
The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China.
Acronym: INITIAL
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