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

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

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).

Study Overview

• Status: Completed
• Conditions: Asthma

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 Type: Observational
• Enrollment (Actual): 4817

Contacts and Locations

Study Locations

• China
  • Baotou, China
    • Research Site
  • Beijing, China
    • Research Site
  • Changsha, China
    • Research Site
  • Changshu, China
    • Research Site
  • Chengdu, China
    • Research Site
  • Chongqing, China
    • Research Site
  • Dalian, China
    • Research Site
  • Daping, China
    • Research Site
  • Fuzhou, China
    • Research Site
  • Guangyuan, China
    • Research Site
  • Guangzhou, China
    • Research Site
  • Harbin, China
    • Research Site
  • Hefei, China
    • Research Site
  • Huhehaote, China
    • Research Site
  • Jining, China
    • Research Site
  • Kunming, China
    • Research Site
  • Mianyang, China
    • Research Site
  • Nantong, China
    • Research Site
  • Qingdao, China
    • Research Site
  • Shanghai, China
    • Research Site
  • ShenZhen, China
    • Research Site
  • Shenyang, China
    • Research Site
  • Shijiazhuang, China
    • Research Site
  • Suining, China
    • Research Site
  • Suzhou, China
    • Research Site
  • Taiyuan, China
    • Research Site
  • Tianjin, China
    • Research Site
  • Wuhan, China
    • Research Site
  • Xian, China
    • Research Site
  • Zhengzhou, China
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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 history, or asthma exacerbation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Newly diagnosed asthma patients; 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?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Jiangtao Lin, PhD, China-Japan Friendship Hospital

Publications and helpful links

General Publications

• Lin JT, Chen P, Zhou X, Sun TY, Xie CM, Xiu QY, Yao WZ, Yang L, Yin KS, Zhang YM. Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma. Chin Med J (Engl). 2012 Sep;125(17):2994-3001.
• Rabe KF, Vermeire PA, Soriano JB, Maier WC. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur Respir J. 2000 Nov;16(5):802-7. doi: 10.1183/09031936.00.16580200.
• Thompson PJ, Salvi S, Lin J, Cho YJ, Eng P, Abdul Manap R, Boonsawat W, Hsu JY, Faruqi RA, Moreno-Cantu JJ, Fish JE, Ho JC. Insights, attitudes and perceptions about asthma and its treatment: findings from a multinational survey of patients from 8 Asia-Pacific countries and Hong Kong. Respirology. 2013 Aug;18(6):957-67. doi: 10.1111/resp.12137.
• Zhao J; National Parents of Asthmatic Children KAP Project Team. [Asthma control status in children and related factors in 29 cities of China]. Zhonghua Er Ke Za Zhi. 2013 Feb;51(2):90-5. Chinese.
• Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
• Juniper EF, O'Byrne PM, Roberts JN. Measuring asthma control in group studies: do we need airway calibre and rescue beta2-agonist use? Respir Med. 2001 May;95(5):319-23. doi: 10.1053/rmed.2001.1034.
• Lin J, Fu X, Jiang P, Song W, Hu X, Jie Z, Liu C, He Z, Zhou X, Tang H. INITIAL - An observational study of disease severity in newly diagnosed asthma patients and initial response following 12 weeks' treatment. Sci Rep. 2019 Feb 4;9(1):1254. doi: 10.1038/s41598-018-36611-w.

Helpful Links

• 10573240
• 11392570
• 22932169
• 11153575
• 23730953
• 23527968
• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2014
• Primary Completion (Actual): September 15, 2016
• Study Completion (Actual): September 15, 2016

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (Estimate): May 21, 2014

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 14, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: NIS-RCN-XXX-2013/2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No