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

Completed

• Conditions: Asthma
• Interventions: Other: without interventions

• Registration Number: NCT01785901
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-07
• Study Start: 2013-05
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1502

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Target subject population 1500	without interventions	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

Primary Outcome Measures

Name	Time	Method
The rate of controlled and partly controlled asthma according to the definition of Global Initiative for Asthma	one day

Secondary Outcome Measures

Name	Time	Method
The rate of completely controlled and well controlled asthma according to Asthma Control Test's score	one day
The average frequency of reliever use in previous week	one day

Trial Locations

Locations (2)

Research Site; 🇨🇳 Wenzhou, Zhejiang, China

Research site; 🇨🇳 Hangzhou, Zhejiang, China