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

Completed

• Conditions: Asthma

• Registration Number: NCT02143739
• Lead Sponsor: AstraZeneca

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).

Study Timeline

• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-21
• Study Start: 2014-06-07
• Primary Completion: 2016-09-15
• Study Completion: 2016-09-15
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4817

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma Severity assessment based on GINA definition (GINA 2006 update) at baseline in the total population	Day 1	severity based on GINA definition (GINA 2006 update) at baseline in the total population.

Secondary Outcome Measures

Name	Time	Method
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	The asthma control status assessment will be based on Assessment of Current Clinical Control in GINA (GINA 2012 update).

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhengzhou, China