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

NCT02881502 | Unknown DMC

• 1 other identifier: Haiqin Guo
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

granulocyte activation; HDAC2; severe asthma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

mild and moderate asthma group

Patients diagnosed with asthma in the outpatient clinic, in accordance with the inclusion criteria and exclusion criteria.

severe asthma group

Outpatient patients with severe asthma diagnosis, in accordance with the inclusion criteria and exclusion criteria.

Other: severe asthma group

Interventions

severe asthma group OTHER

No intervention

severe asthma group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

outpatients and the students

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

XijingH

Xian, Shanxi, 780032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Wu C gui, professor

  Xijing Hospital

  STUDY DIRECTOR

Central Study Contacts

Guo H qin, Graduate

CONTACT

18194278935; hqgsunshine@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree Candidate,Student of Respiratory Medicine

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: August 29, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 29, 2016

Record last verified: 2016-08

Locations

CN (1)