- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02881502
Clinical Study of Relationship Between Granulocyte Activation, HDAC2 and Severe Asthma
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Shanxi
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Xian, Shanxi, Kina, 780032
- Rekruttering
- XijingH
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Ta kontakt med:
- Guo H qin, graduate
- Telefonnummer: 029 18194278935
- E-post: hqgsunshine@163.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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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.
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mild and moderate asthma group
Patients diagnosed with asthma in the outpatient clinic, in accordance with the inclusion criteria and exclusion criteria.
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severe asthma group
Outpatient patients with severe asthma diagnosis, in accordance with the inclusion criteria and exclusion criteria.
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No intervention
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Evidence of clinically definite severe asthma confirmed by the plasma concentration of blood related indexes(MPO、MMP-9、NE、ECP、HDAC2)
Tidsramme: one year
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Compare the difference was not statistically significant of the different groups by testing the concentration of blood related indicators of subjects
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one year
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Wu C gui, professor, Xijing Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Haiqin Guo
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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