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

AstraZeneca

Status: Completed

Conditions: Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT02143739

NIS-RCN-XXX-2013/2

Details and patient eligibility

About

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).

Full 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).

Enrollment: 4,817 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,817 participants in 1 patient group

Newly diagnosed asthma patients

Description:

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.