Clinical trial NCT02881502: Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: granulocyte activation
HDAC2
severe asthma
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients and the students

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evidence of clinically definite severe asthma confirmed by the plasma concentration of blood related indexes(MPO、MMP-9、NE、ECP、HDAC2)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Xian
country: China
facility: XijingH
state: Shanxi
Study officials:
affiliation: Xijing Hospital
name: Wu C gui, professor
role: STUDY_DIRECTOR
References: