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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01785901
First received: February 5, 2013
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Asthma
Other: without interventions

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Asthma Control Rate Achieved by Budesonide/Formoterol in Clinical Practice in China

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The rate of controlled and partly controlled asthma according to the definition of Global Initiative for Asthma [ Time Frame: one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The rate of completely controlled and well controlled asthma according to Asthma Control Test's score [ Time Frame: one day ] [ Designated as safety issue: No ]
  • The average frequency of reliever use in previous week [ Time Frame: one day ] [ Designated as safety issue: No ]

Enrollment: 1500
Study Start Date: May 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: without interventions

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Asthma patients from clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785901

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Chongqing
Research Site
Chongqing, Chongqing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Heilongjiang
Research Site
Harbin, Heilongjiang, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Inner Mongolia
Research Site
Baotou, Inner Mongolia, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
China, Shandong
Research Site
Qingdao, Shandong, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Zhejiang
Research site
Hangzhou, Zhejiang, China
Research Site
Wenzhou, Zhejiang, China
Sponsors and Collaborators
AstraZeneca
  More Information

Publications:
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.

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01785901     History of Changes
Other Study ID Numbers: NIS-RCN-SYM-2012/1
Study First Received: February 5, 2013
Last Updated: October 10, 2014
Health Authority: China: China Ethics Committee

Keywords provided by AstraZeneca:
asthma
control rate
budesonide/formoterol
Non-Interventional study

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Budesonide
Formoterol
Symbicort
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014