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

NCT ID: NCT01785901

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1502 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Target subject population 1500

Asthma patients who have already received the treatment of budesonide/formoterol by physicians' determination and whose medications are aligned with the package insert of budesonide/formoterol approved in China

without interventions

Intervention Type OTHER

without interventions

Interventions

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without interventions

without interventions

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Beijing, Beijing Municipality, China

Site Status

Research Site

Chongqing, Chongqing Municipality, China

Site Status

Research Site

Guangzhou, Guangdong, China

Site Status

Research Site

Harbin, Heilongjiang, China

Site Status

Research Site

Changsha, Hunan, China

Site Status

Research Site

Baotou, Inner Mongolia, China

Site Status

Research Site

Nanjing, Jiangsu, China

Site Status

Research Site

Qingdao, Shandong, China

Site Status

Research Site

Chengdu, Sichuan, China

Site Status

Research site

Hangzhou, Zhejiang, China

Site Status

Research Site

Wenzhou, Zhejiang, China

Site Status

Countries

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China

References

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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. doi: 10.1016/0006-2944(75)90147-7. No abstract available.

Reference Type BACKGROUND
PMID: 1 (View on PubMed)

Lin J, Li J, Yu W, Liu Y, Liu C, Chen P, He H, He B, Liu S, Zhou X. A multicenter, cross-sectional, observational study of budesonide/formoterol maintenance and reliever therapy in real-world settings. Respir Med. 2017 Jun;127:45-50. doi: 10.1016/j.rmed.2017.04.004. Epub 2017 Apr 6.

Reference Type DERIVED
PMID: 28502418 (View on PubMed)

Related Links

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Other Identifiers

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NIS-RCN-SYM-2012/1

Identifier Type: -

Identifier Source: org_study_id

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