The Asthma Control Rate Achieved by Budesonide/Formoterol in Clinical Practice in China

Asthma Clinical Trial

Official title:

The Asthma Control Rate Achieved by Budesonide/Formoterol in Clinical Practice in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785901
• Other study ID #: NIS-RCN-SYM-2012/1
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: August 17, 2016
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: China Ethics Committee
• Study type: Observational

Clinical Trial Summary

This is a multi-centre, cross-sectional study planned to be conducted in China. The study aims to observe about 1500 asthma patients who have already received budesonide/formoterol combination treatment by physicians' determination and whose medications are aligned with the package insert of budesonide/formoterol approved in China.

Description:

The asthma control rate achieved by budesonide/formoterol in clinical practice in China.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1502
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of asthma at least 6 months;

2. Prescribed with budesonide/formoterol treatment at least 3 months before enrolled;

3. Has used the same maintenance dose of budesonide/formoterol for at least 4 weeks before enrolled.

Exclusion Criteria:

1. Participation in any clinical study within 3 months;

2. Have COPD history/suspicious COPD;

3. = 10 pack years of smoking history

4. Used any other asthma maintenance medication accompanied with budesonide/formoterol within 3 months before enrolled

5. With asthma exacerbation (defined as asthma symptom deterioration resulting oral/rectal/parenteral GCS medication or emergency room treatment or hospitalisation) within 4 weeks before enrolled

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• without interventions
without interventions

Locations

Country	Name	City	State
China	Research Site	Baotou	Inner Mongolia
China	Research Site	Beijing	Beijing
China	Research Site	Changsha	Hunan
China	Research Site	Chengdu	Sichuan
China	Research Site	Chongqing	Chongqing
China	Research Site	Guangzhou	Guangdong
China	Research site	Hangzhou	Zhejiang
China	Research Site	Harbin	Heilongjiang
China	Research Site	Nanjing	Jiangsu
China	Research Site	Qingdao	Shandong
China	Research Site	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

References & Publications (1)

Makar AB, McMartin KE, Palese M, Tephly TR. Formate assay in body fluids: application in methanol poisoning. Biochem Med. 1975 Jun;13(2):117-26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of controlled and partly controlled asthma according to the definition of Global Initiative for Asthma		one day	No
Secondary	The rate of completely controlled and well controlled asthma according to Asthma Control Test's score		one day	No
Secondary	The average frequency of reliever use in previous week		one day	No

External Links

•   CSR Synopsis
•   Lin et al Asthma Control NIS abstract_2015 APSR. Abstract ID: 310