Gene Expression Profile and Inflammation Profile of Classic Asthma, Cough Variant Asthma and Eosinophilic Bronchitis
Gene Expression Profile and Inflammation Profile of Classic Asthma, Cough Variant Asthma and Eosinophilic Bronchitis
This study aims to identify and validate the gene expression differentials of peripheral
 blood mononuclear cells and differential inflammation profiles and other aspects in classic
 asthma, cough-variant asthma and eosinophilic bronchitis.
Asthma is a common and heterogeneous respiratory disorder affecting millions of people,
 posing a considerable burden on health care systems globally. The disease is characterized by
 inflammation of the airways with eosinophils, neutrophils, mast cells, lymphocytes, airway
 epithelial cells, smooth muscle cells and other cells, by airflow obstruction and by
 bronchial hyperresponsiveness. The disease is triggered by multiple gene-environment
 interactions. Asthma heterogeneity is recognized in terms of clinical phenotypes of asthma
 whereby classic asthma (CA) and cough variant asthma (CVA) are identified. classic asthma is
 a common phenotype of asthma that presents episodic dyspnoea and wheezing with or without
 cough. Cough variant asthma is a phenotype of asthma that presents solely cause of chronic
 cough.

 Eosinophilic bronchitis (EB) is a common cause of chronic cough, which like eosinophils
 asthma is characterized by airway eosinophilic inflammation, but unlike asthma there is no
 airway hyperresponsiveness or variable airflow obstruction.

 Improvement of disease diagnosis and management require a better understanding of disease
 heterogeneity. A useful biomarker for phenotype recognition will represent underlying
 pathologic mechanisms of disease, marking heterogeneity and guiding personalized treatment
 approaches. Our hypothesis was that the different clinical manifestos in patients with
 eosinophilic bronchitis, classic asthma, and cough-variant asthma could be caused by
 differential gene expression profiles of peripheral blood mononuclear cells (PBMC) and
 differential inflammation profiles and other aspects.
Inclusion Criteria:

 The patients with classic asthma inclusion criteria Asthmatic patient inclusion criteria

 1. Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form
 prior to initiation of any study-related procedure.

 2. The patients with classic asthma had a history of episode dyspnea and wheezing with or
 without cough.

 3. Clinical diagnosis of asthma confirmed by a chest physician according to international
 guidelines (GINA 2014); methacholine airway hyperresponsiveness (provocative
 concentration of methacholine causing a 20% fall in FEV1(forced expiratory volume at
 one second )【PD20】),>12% improvement in FEV1 10 min after inhaling 200ug of
 salbutamol.

 4. None of the patients with classic asthma had used inhaled or oral corticosteroids,
 long-acting β2-agonists, leukotriene antagonists, sodium cromoglycate,or nedocromil
 sodium, anticholinergic agents, during four weeks prior to entry into the study.

 The patients with CVA inclusion criteria

 1. Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form
 prior to initiation of any study-related procedure.

 2. The diagnosis of CVA is based on isolated cough lasting for ≥ 8 weeks without wheezing
 or dyspnea, airway hyperresponsiveness (AHR), and relief of cough with bronchodilators
 according to recommendations in the Chinese national guidelines on the diagnosis and
 management of cough.

 3. None of the patients with CVA had used inhaled or oral corticosteroids, long-acting
 β2-agonists, leukotriene antagonists, sodium cromoglycate,or nedocromil sodium,
 anticholinergic agents, during four weeks prior to entry into the study.

 The patients with EB inclusion criteria

 1. Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form
 prior to initiation of any study-related procedure.

 2. The diagnosis of EB is based on cough lasting for ≥ 8 weeks according to
 recommendations in the Chinese national guidelines on the diagnosis and management of
 cough.

 3. None of the patients with EB had used inhaled or oral corticosteroids, long-acting
 β2-agonists, leukotriene antagonists, sodium cromoglycate,or nedocromil sodium,
 anticholinergic agents, during four weeks prior to entry into the study.

 Healthy subjects inclusion criteria

 1. Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form
 prior to initiation of any study-related procedure.

 2. Normal spirometry: baseline FEV1 ≥ 80% of the predicted normal value, FEV1/FVC(forced
 vital capacity) > LLN (lower limit of normal).

 3. Normal airways responsiveness.

 4. Healthy subjects have no any disease or negative allergen skin prick test results.

 Exclusion Criteria:

 Patients with classic asthma, CVA and EB exclusion criteria

 The presence of any of the following will exclude a subject from study enrolment:

 Current smokers, ex-smokers. Individuals with respiratory infection during the previous one
 month. Clinical history of chronic obstructive pulmonary disease(COPD), bronchiectasis,
 pulmonary embolism.

 Clinical history of haematological, immunologic, renal, neurologic, hepatic, endocrinal or
 other disease, or any condition that might compromise the results or interpretation of the
 study.

 Asthma exacerbation and unstable asthma . Pregnant or lactating women.