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

August 17, 2016 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

1502

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Research Site
    • Chongqing
      • Chongqing, Chongqing, China
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China
        • Research Site
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Research Site
    • Hunan
      • Changsha, Hunan, China
        • Research Site
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Research Site
    • Shandong
      • Qingdao, Shandong, China
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, China
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Research Site
      • Wenzhou, Zhejiang, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Asthma patients from clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: without interventions
without interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of controlled and partly controlled asthma according to the definition of Global Initiative for Asthma
Time Frame: one day
one day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-RCN-SYM-2012/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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