Gene Expression Profile and Inflammation Profile of Classic Asthma, Cough Variant Asthma and Eosinophilic Bronchitis

NCT02555345 | Unknown

• 1 other identifier: RZ-689
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthmatic Bronchitis

Keywords

classic asthma, cough variant asthma,eosinophilic bronchitis

Outcome Measures

Primary Outcomes (1)

• Difference in Gene Expression Profile of Peripheral Blood Mononuclear Cells in Classic Asthma,Cough Variant Asthma and Eosinophilic Bronchitis Compared with Healthy Controls

  Five milliliters of venous blood was collected. The peripheral blood mononuclear cells(PBMC) were isolated by the Ficoll-Paque plus(GE Healthcare Bio-Sciences Corp, NJ ) according to the manufacture's recommendations. RNA from PBMC was extracted. RNA-seq, a high throughput RNA sequencing technology, would characterize the transcriptome by sequencing complementary cDNAs followed by mapping of the sequence reads to the genome.

  15 months

Secondary Outcomes (7)

• Induced sputum cytology

  15 months

• Airway inflammation indices

  15 months

• Fractional exhaled nitric oxide Measurements

  15 months

• Peripheral blood eosinophil counts, serum IgE assessment

  15 months

• Cumulative provocative dose causing 20% fall in FEV1 measured through the Methacholine bronchial challenge test

  15 months

Study Arms (4)

classic asthma/No intervention

Patients with classic asthma were stable.Chest X-ray or CT scan was normal.Fenofibrate(FeNO) was performed.Spirometry was needed. The leicester cough questionnaire (LCQ) was offered to physicians.Sputum,blood and urine samples were collected to study genetic, inflammation and other aspects of these diseases.

CVA/No intervention

Chest X-ray or CT scan was normal.FeNO was performed. Spirometry was needed. The LCQ was offered to physicians. Sputum,blood and urine samples were collected to study genetic, inflammation and other aspects of these diseases.

EB/No intervention

Chest X-ray or CT scan was normal.FeNO was performed. Spirometry was needed. The LCQ was offered.Sputum,blood and urine samples were collected to study genetic, inflammation and other aspects of these diseases.

Healthy/No intervention

Chest X-ray or CT scan was normal.FeNO was performed.Spirometry was needed. Sputum,blood and urine samples were collected to study genetic, inflammation and other aspects of these diseases.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All of subjects with classic asthma, CVA, eosinophilic bronchitis, and healthy volunteers are recruited from respiratory outpatient clinics and from staff at the First Affiliated Hospital of Guangzhou Medical College between October 25, 2014 and January 20,2016.

You may qualify if:

• Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form prior to initiation of any study-related procedure.
• The patients with classic asthma had a history of episode dyspnea and wheezing with or without cough.
• 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.
• 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.
• Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form prior to initiation of any study-related procedure.
• 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.
• 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.
• Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form prior to initiation of any study-related procedure.
• 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.
• 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.
• Male or female patients aged ≥ 18 and ≤ 65, who have signed an Informed Consent form prior to initiation of any study-related procedure.
• Normal spirometry: baseline FEV1 ≥ 80% of the predicted normal value, FEV1/FVC(forced vital capacity) \> LLN (lower limit of normal).
• Normal airways responsiveness.
• Healthy subjects have no any disease or negative allergen skin prick test results.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State Key Laboratory of Respiratory Disease: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample collection for future analysis (including genetic tests on DNA) on the pathobiology of diseases.

MeSH Terms

Conditions

Bronchiolitis; Cough-Variant Asthma

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Asthma; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kefang Lai, PHD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kefang Lai, PHD

CONTACT

8620-83062887; klai@163.com

Nanshan Zhong, MD

CONTACT

8620-83062718; nanshan@vip.163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RUI ZHANG

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 21, 2015
• Study Start: October 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 21, 2015

Record last verified: 2015-09

Locations

CN (1)