Overview

This trial has been completed.

Condition asthma
Sponsor AstraZeneca
Start date June 2014
End date September 2016
Trial size 4939 participants
Trial identifier NCT02143739, NIS-RCN-XXX-2013/2

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
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.

Primary Outcomes

Measure
Asthma Severity assessment based on GINA definition (GINA 2006 update) at baseline in the total population
time frame: Day 1

Secondary Outcomes

Measure
evaluate the control level of initial 12 weeks treatment based on Assessment of Current Clinical Control in GINA (GINA 2012 update).
time frame: up to 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China.
Principal investigator Jiangtao Lin, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.