AsthmaNCT02881502
Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe Asthma
An observational study of Asthma, run by Xijing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- severe asthma group
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: outpatients and the students
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
XijingH
Xian, Shanxi, 780032
Guo H qin, graduate, 18194278935 ext. 029, hqgsunshine@163.com
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- severe asthma group
- Keywords
- granulocyte activation, HDAC2, severe asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
severe asthma groupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: severe asthma group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiqin Guo, Xijing Hospital
- Investigators
- Wu C gui, professor, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881502
- Sponsor's protocol ID
- Haiqin Guo
- Status last verified
- Aug 2016
- First submitted
- 15 Jul 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe Asthma
- ClinicalTrials.gov ID
- NCT02881502
- Acronym / sponsor ID
- Haiqin Guo
- Conditions
- Asthma
- Keywords
- granulocyte activation, HDAC2, severe asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: severe asthma groupOutpatient patients with severe asthma diagnosis, in accordance with the inclusion criteria and exclusion criteria. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients and the students
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| severe asthma groupNo intervention | Other | severe asthma group |
Primary outcome
Evidence of clinically definite severe asthma confirmed by the plasma concentration of blood related indexes(MPO、MMP-9、NE、ECP、HDAC2)
Time frame: one year
Compare the difference was not statistically significant of the different groups by testing the concentration of blood related indicators of subjects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wu C gui, professor study director
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guo H qin, Graduate (18194278935 ext. 029, hqgsunshine@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinically definite severe asthma confirmed by the plasma concentration of blood related indexes(MPO、MMP-9、NE、ECP、HDAC2) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.