Treatment Efficacy of Budesonide/Formoterol in Cough Variant Asthma and Typical Asthma Patients

Bronchial Asthma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02934945
• Other study ID #: 2015-HXNK-004
• Status: Recruiting
• Phase: Phase 4
• First received: October 7, 2016
• Last updated: October 13, 2016
• Start date: September 2015
• Est. completion date: March 2017

Study information

• Verified date: July 2016
• Source: Zhujiang Hospital
• Contact: Shuyu Chen, M.D
• Phone: +8613580421202
• Email: 1137968694[@]qq.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

Inclusion Criteria:

1. aged 15-75

2. first diagnosed corresponding to the diagnostic standards established by Asthma Committee, Respiratory Society, Chinese Medical Association, or previously diagnosed asthma without regular treatment

3. Mch bronchial provocation test is positive

4. the chest X-ray is normal.

Exclusion Criteria:

1. accompanied by other disease of respiratory system

2. combined with serious illness of other system, such as myocardial infarction, severe arrhythmia, malignant tumors and so on

3. women with pregnancy or lactation.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• budesonide 160µg/formoterol 4.5µg
SMART regimen

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in first second		up to six months	Yes
Secondary	forced vital capacity		up to six months	Yes
Secondary	Fractional Exhaled Nitric Oxide		up to six months	No
Secondary	Asthma Controlled Test		up to six months	No
Secondary	Bronchial Provocation Test		up to six months	No