Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe Asthma

Asthma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02881502
• Other study ID #: Haiqin Guo
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2016
• Last updated: August 23, 2016
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: August 2016
• Source: Xijing Hospital
• Contact: Guo H qin, Graduate
• Phone: 18194278935
• Email: hqgsunshine[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Program： Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe Asthma Aim：The early prediction of severe asthma, early intervention on the disease, reduce the family and the national finance.

design:This study is a single center randomized controlled trial designed by the Department of respiratory medicine, Xijing Hospital, as the main research unit.Compare the case group(severe asthma group and mild-and-moderate asthma group) and control group(healthy control group) by detecting the activity of MPO、NE、MMP-9 and ECP in the peripheral blood and the activity of HDAC2 in PBMCs of patients.

case:60

Case selection:

Inclusion criteria: age 18-75 years old; diagnosis of asthma was clear; informed consent was signed.

Exclusion criteria: poor compliance; cognitive ability is low; psychiatric disorders need to be combined with psychotropic medication.

Description:

Application of SPSS 19 statistical software. Measurement data were expressed as mean ± standard deviation.

First the data is normality tested and homogeneity of variance tested, according to the measurement data of normal distribution by SNK single factor analysis of variance; does not conform to the normal distribution of measurement data, using the Kruskal Wallis non parametric test. P < 0.05 for the difference was statistically significant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

inclusion criteria: healthy control group:

• Mainly from students,

• family members of patients without chronic lung disease,

• healthy population,

• age 18-75 years old, the gender is not limited. case group:

• The patient has been diagnosed with asthma in the outpatient clinic. The diagnostic criteria are in accordance with the Guidelines for Prevention and Treatment of Bronchial Asthma in the respiratory disease branch of the Chinese Medical Association.

In the past 1 year need guidelines of global asthma record instrument 4-5 drug treatment of asthma [high dose inhaled corticosteroid with long-acting beta2 receptor agonist or leukotriene modifiers / theophylline or systemic hormone therapy is more than or equal to 50% of the time, in order to prevent into uncontrolled asthma, or even in the treatment is to control asthma patients for severe asthma.

exclusion criteria:

• Poor treatment compliance, or low cognitive ability to impact the self rating scale ;

• There are serious heart, liver, renal dysfunction, or other infectious diseases ;

• The individual who refuse to sign the informed consent.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• severe asthma group
No intervention

Locations

Country	Name	City	State
China	XijingH	Xian	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinically definite severe asthma confirmed by the plasma concentration of blood related indexes(MPO?MMP-9?NE?ECP?HDAC2)	Compare the difference was not statistically significant of the different groups by testing the concentration of blood related indicators of subjects	one year	Yes