NCT01785901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

February 5, 2013

Last Update Submit

August 17, 2016

Conditions

Asthma

Keywords

asthmacontrol ratebudesonide/formoterolNon-Interventional study

Outcome Measures

Primary Outcomes (1)

  • The rate of controlled and partly controlled asthma according to the definition of Global Initiative for Asthma

    one day

Secondary Outcomes (2)

  • 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

Study Arms (1)

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

Interventions

without interventionsOTHER

without interventions

Target subject population 1500

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Asthma patients from clinic

You may qualify if:

  • Clinical diagnosis of asthma at least 6 months;
  • Prescribed with budesonide/formoterol treatment at least 3 months before enrolled;
  • Has used the same maintenance dose of budesonide/formoterol for at least 4 weeks before enrolled.

You may not qualify if:

  • Participation in any clinical study within 3 months;
  • Have COPD history/suspicious COPD;
  • ≥ 10 pack years of smoking history
  • Used any other asthma maintenance medication accompanied with budesonide/formoterol within 3 months before enrolled
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Chongqing, Chongqing Municipality, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Harbin, Heilongjiang, China

Location

Research Site

Changsha, Hunan, China

Location

Research Site

Baotou, Inner Mongolia, China

Location

Research Site

Nanjing, Jiangsu, China

Location

Research Site

Qingdao, Shandong, China

Location

Research Site

Chengdu, Sichuan, China

Location

Research site

Hangzhou, Zhejiang, China

Location

Research Site

Wenzhou, Zhejiang, China

Location

Related Publications (2)

  • 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.

    PMID: 1BACKGROUND

  • 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.

    PMID: 28502418DERIVED

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Methods

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

CN(11)