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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Asthma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Participating in any clinical trial during the last 90 days Have COPD With asthma exacerbation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly diagnosed asthma patients<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma