Gender Differences and SNPs in Asthmatic Patients

Asthma Clinical Trial

Official title:

Gender Differences and SNPs in Asthmatic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04567212
• Other study ID #: SNPS asthma
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2020
• Source: University of Catanzaro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2021
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Genetic:
• 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.

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

Locations

Country	Name	City	State
Italy	AO Materdomini	Catanzaro	Italia
Italy	ASP Catanzaro	Catanzaro

Sponsors (3)

Lead Sponsor	Collaborator
University of Catanzaro	Azienda Ospedaliera Policlinico "Mater Domini", Azienda Sanitaria Provinciale Di Catanzaro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of SNPs	statistically significant difference (P<0.05) in SNPs expression between male and female	1 month
Secondary	Concentration of MicroRNA	statistically significant difference (P<0.05) in microRNA between male and female	1 month
Secondary	SNPs and age	statistically significant difference (P<0.05) in SNPs expression between age > 12 years and < 12 years	1 month