Gender Differences and SNPs in Asthmatic Patients

Study Overview
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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.

Official Title
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Gender Differences and SNPs in Asthmatic Patients

Conditions
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Allergic Asthma, Asthma

Intervention / Treatment
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* Genetic: genetic evaluation
* Other: MicroRNA evaluation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male-group<br>in this group we will enroll only male with asthma | Genetic: genetic evaluation<br>* 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.<br>Other: MicroRNA evaluation<br>* Using the sampe of blood (3 mL) using RT-PCR we will evaluate the expression of microRNA in enrolled patients<br>|
| Female-group<br>in this group we will enroll only female with asthma | Genetic: genetic evaluation<br>* 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.<br>Other: MicroRNA evaluation<br>* Using the sampe of blood (3 mL) using RT-PCR we will evaluate the expression of microRNA in enrolled patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of SNPs | statistically significant difference (P<0.05) in SNPs expression between male and female | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of MicroRNA | statistically significant difference (P<0.05) in microRNA between male and female | 1 month | 
| SNPs and age | statistically significant difference (P<0.05) in SNPs expression between age > 12 years and < 12 years | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, allergy, Gender, polymorphism