Gender Differences and SNPs in Asthmatic Patients

November 20, 2020 updated by: Luca Gallelli, University of Catanzaro
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • Recruiting
        • ASP Catanzaro
        • Contact:
        • Sub-Investigator:
          • Antonio Scuteri, MD
        • Sub-Investigator:
          • Giacomo Leuzzi, MD
        • Sub-Investigator:
          • Giuseppe Giuliano, MD
    • Italia
      • Catanzaro, Italia, Italy, 88100
        • Recruiting
        • AO Materdomini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We will perform an observational study in patients with asthma enrolled fro general practitioners and specialist in respiratory disease. After the recruitment a sample of blood and oral mucosa will be taken to evaluate the expression of SNPs and of inflammatory status

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Male-group
in this group we will enroll only male with asthma
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
Female-group
in this group we will enroll only female with asthma
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catanzaro

Collaborators

Azienda Sanitaria Provinciale Di Catanzaro
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ANTICIPATED)

November 20, 2021

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (ACTUAL)

September 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNPS asthma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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