We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01785901
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : August 19, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Asthma Other: without interventions

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

Study Design

Study Type : Observational
Actual Enrollment : 1502 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Asthma Control Rate Achieved by Budesonide/Formoterol in Clinical Practice in China
Study Start Date : May 2013
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. The rate of controlled and partly controlled asthma according to the definition of Global Initiative for Asthma [ Time Frame: one day ]

Secondary Outcome Measures :
  1. The rate of completely controlled and well controlled asthma according to Asthma Control Test's score [ Time Frame: one day ]
  2. The average frequency of reliever use in previous week [ Time Frame: one day ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Asthma patients from clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785901

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
More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01785901     History of Changes
Other Study ID Numbers: NIS-RCN-SYM-2012/1
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by AstraZeneca:
control rate
Non-Interventional study

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