Clinical trial NCT01785901: The Asthma Control Rate Achieved by Budesonide/Formoterol in Clinical Practice in China
Official title: The Asthma Control Rate Achieved by Budesonide/Formoterol in Clinical Practice in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
control rate
budesonide/formoterol
Non-Interventional study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 1502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Asthma patients from clinic

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: The rate of controlled and partly controlled asthma according to the definition of Global Initiative for Asthma
timeFrame: one day
Secondary outcomes:
measure: The rate of completely controlled and well controlled asthma according to Asthma Control Test's score
timeFrame: one day
measure: The average frequency of reliever use in previous week
timeFrame: one day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Harbin
country: China
facility: Research Site
state: Heilongjiang
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Baotou
country: China
facility: Research Site
state: Inner Mongolia
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Qingdao
country: China
facility: Research Site
state: Shandong
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Hangzhou
country: China
facility: Research site
state: Zhejiang
city: Wenzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
References:
citation: 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.
citation: 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.