Treatment Efficacy of Budesonide/Formoterol in Cough Variant Asthma and Typical Asthma Patients
Primary Purpose
Bronchial Asthma
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
budesonide 160μg/formoterol 4.5μg
Sponsored by

About this trial
This is an interventional treatment trial for Bronchial Asthma focused on measuring Budesonide/formoterol, Typical asthma, Cough variant asthma
Eligibility Criteria
Inclusion Criteria:
- aged 15-75
- first diagnosed corresponding to the diagnostic standards established by Asthma Committee, Respiratory Society, Chinese Medical Association, or previously diagnosed asthma without regular treatment
- Mch bronchial provocation test is positive
- the chest X-ray is normal.
Exclusion Criteria:
- accompanied by other disease of respiratory system
- combined with serious illness of other system, such as myocardial infarction, severe arrhythmia, malignant tumors and so on
- women with pregnancy or lactation.
Sites / Locations
- Zhujiang Hospital of Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
patients with CVA(CVA group)
patients with TA(TA group)
Arm Description
budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for six months
budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for six months
Outcomes
Primary Outcome Measures
Forced Expiratory Volume in first second
Secondary Outcome Measures
forced vital capacity
Fractional Exhaled Nitric Oxide
Asthma Controlled Test
Bronchial Provocation Test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02934945
Brief Title
Treatment Efficacy of Budesonide/Formoterol in Cough Variant Asthma and Typical Asthma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bronchial asthma is a common respiratory disease characterized by chronic airway inflammation, which have been affecting about 1-18% of the population in the world, causing tremendous economic burden for the patients and countries. Generally, asthma is a heterogeneous disease, and it could be classified into many types on the basis of symptoms, that is, typical asthma, cough variant asthma, and chest tightness variant asthma etc. Typical asthma (TA) is defined according to the history of repeated respiratory symptoms such as wheeze, shortness of breath, chest tightness, and cough, usually with reversible airflow limitation, airway hyper-responsiveness, and airway remodeling. Cough variant asthma (CVA) is characterized by the single manifestation, recurrent cough, which could be improved after the use of bronchodilators. However, according to different guidelines, it is still controversial on the treatment of CVA and TA. The guidelines of Global Initiative for Asthma(GINA) in 2014 put forward the treatment of TA patients, but did not list the treatment specific to CVA. The guideline of ACCP(American College of Chest Physicians) and cough guidelines of China are proposed to treat the CVA effectively with bronchial diastolic drug. Inhaled corticosteroids (ICS) and leukotriene receptor antagonists are effective for the treatment of CVA. Currently, more and more studies supported that application of ICS combined with bronchial dilation agents is more beneficial to CVA patients. Budesonide/formoterol is a compound of ICS and long-acting beta2-agonist(LABA), which can not only be used as a maintenance medication, but also be used as a relief medication, namely, budesonide/formoterol treatment regimen for SMART (Symbicort as both maintenance and reliever therapy). Most studies show that SMART treatment can be used in the treatment of TA patients. But the study on whether budesonide/formoterol can be used to treat CVA is still little. To provide basis for clinical medication guidance for patients with CVA and TA, this study will enroll 30 patients with TA or CVA , who will be required to adopt the SMART regimen in the following 6 months.The symptom score, airway inflammation, pulmonary function and airway reactivity changes, will be measured every mouth. After the study finished, the investigators will compare the difference between the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
Keywords
Budesonide/formoterol, Typical asthma, Cough variant asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with CVA(CVA group)
Arm Type
Other
Arm Description
budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for six months
Arm Title
patients with TA(TA group)
Arm Type
Other
Arm Description
budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for six months
Intervention Type
Drug
Intervention Name(s)
budesonide 160μg/formoterol 4.5μg
Other Intervention Name(s)
Symbicort
Intervention Description
SMART regimen
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in first second
Time Frame
up to six months
Secondary Outcome Measure Information:
Title
forced vital capacity
Time Frame
up to six months
Title
Fractional Exhaled Nitric Oxide
Time Frame
up to six months
Title
Asthma Controlled Test
Time Frame
up to six months
Title
Bronchial Provocation Test
Time Frame
up to six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 15-75
first diagnosed corresponding to the diagnostic standards established by Asthma Committee, Respiratory Society, Chinese Medical Association, or previously diagnosed asthma without regular treatment
Mch bronchial provocation test is positive
the chest X-ray is normal.
Exclusion Criteria:
accompanied by other disease of respiratory system
combined with serious illness of other system, such as myocardial infarction, severe arrhythmia, malignant tumors and so on
women with pregnancy or lactation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuyu Chen, M.D
Phone
+8613580421202
Email
1137968694@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jielu Liu, M.D
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huapeng Yu, Ph.D
Organizational Affiliation
Southern Medical University, China
Official's Role
Study Director
Facility Information:
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuyu Chen, M.D
Phone
13580421202
Email
1137968694@qq.com
First Name & Middle Initial & Last Name & Degree
Jielu Liu, M.D
12. IPD Sharing Statement
Learn more about this trial
Treatment Efficacy of Budesonide/Formoterol in Cough Variant Asthma and Typical Asthma Patients
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