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Gender Differences and SNPs in Asthmatic Patients

NCT ID: NCT04567212

Last Updated: 2020-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-12-30

Brief Summary

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The GINA 2020 guidelines suggest that asthma affects approximately 300 million persons worldwide. Even if there is a specific drug treatment for each stage of disease (From mild to severe) in some patients it is not efficacy and it culd be reated to the gender difference Polymorphisms seems to be involved in asthma (allergic or not) even if no data have been published concerning the role of gender in this clinical manifestation. The aim of this study is to assess whether genetic variations involved in the genes encoding the two key leukotriene enzymes, ALOX5 and LTC4S, and CysLTR1 are implicated in the sex difference of allergic asthma in a well-characterized patient cohort.

Detailed Description

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The GINA 2020 guidelines suggest that asthma affects approximately 300 million persons worldwide. Even if there is a specific drug treatment for each stage of disease (From mild to severe) in some patients it is not efficacy and it culd be reated to the gender difference Polymorphisms seems to be involved in asthma (allergic or not) even if no data have been published concerning the role of gender in this clinical manifestation. The role of polymorphisms in susceptibility to allergic asthma has been partially investigated but no study has analysed gender subgroups separately, neglecting a their potential predictive role in symptomatological and functional variations in the allergic asthma in both sexes. The aim of this study is to assess whether genetic variations involved in the genes encoding the two key leukotriene enzymes, ALOX5 and LTC4S, and CysLTR1 are implicated in the sex difference of allergic asthma in a well-characterized patient cohort.

Conditions

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Allergic Asthma Asthma

Keywords

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asthma allergy Gender polymorphism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Male-group

in this group we will enroll only male with asthma

genetic evaluation

Intervention Type GENETIC

A sampe of blood (3 mL) and of oral mucosa will be take and analyzed using nCounter GX Human Inflammation Kit a comprehensive number of 8SNPs in 3 human genes known to be differentially expressed in allergic asthma.

MicroRNA evaluation

Intervention Type OTHER

Using the sampe of blood (3 mL) using RT-PCR we will evaluate the expression of microRNA in enrolled patients

Female-group

in this group we will enroll only female with asthma

genetic evaluation

Intervention Type GENETIC

A sampe of blood (3 mL) and of oral mucosa will be take and analyzed using nCounter GX Human Inflammation Kit a comprehensive number of 8SNPs in 3 human genes known to be differentially expressed in allergic asthma.

MicroRNA evaluation

Intervention Type OTHER

Using the sampe of blood (3 mL) using RT-PCR we will evaluate the expression of microRNA in enrolled patients

Interventions

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genetic evaluation

A sampe of blood (3 mL) and of oral mucosa will be take and analyzed using nCounter GX Human Inflammation Kit a comprehensive number of 8SNPs in 3 human genes known to be differentially expressed in allergic asthma.

Intervention Type GENETIC

MicroRNA evaluation

Using the sampe of blood (3 mL) using RT-PCR we will evaluate the expression of microRNA in enrolled patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* asthma (allergic or not) diagnosed according to Global Initiative for Asthma guidelines (GINA 2020).
* signed informed consent

Exclusion Criteria

* • infectious diseases

* neurodegenerative diseases
* autoimmune diseases
* neoplasms
* progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
* alcohol consumption (\>3 alcoholic beverages daily)
* substanceabuse
* inability to give written informed consent
* those who will not sign the consent to the processing of personal data
Minimum Eligible Age

6 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda Sanitaria Provinciale Di Catanzaro

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

OTHER

Sponsor Role collaborator

University of Catanzaro

OTHER

Sponsor Role lead

Responsible Party

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Luca Gallelli

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AO Materdomini

Catanzaro, Italia, Italy

Site Status RECRUITING

ASP Catanzaro

Catanzaro, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Luca Gallelli, MD

Role: primary

Antonio Guerra, MD

Role: primary

Other Identifiers

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SNPS asthma

Identifier Type: -

Identifier Source: org_study_id