Treatment Efficacy of Budesonide/Formoterol in Cough Variant Asthma and Typical Asthma Patients
Status:
Unknown status
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Zhujiang Hospital
Treatments:
Budesonide Budesonide, Formoterol Fumarate Drug Combination Formoterol Fumarate