Clinical trial NCT04567212: Gender Differences and SNPs in Asthmatic Patients
Official title: Gender Differences and SNPs in Asthmatic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Asthma
Asthma
Keywords: asthma
allergy
Gender
polymorphism
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria Provinciale Di Catanzaro
name: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
First posted: 2020-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Expression of SNPs
timeFrame: 1 month
Secondary outcomes:
measure: Concentration of MicroRNA
timeFrame: 1 month
measure: SNPs and age
timeFrame: 1 month
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: AO Materdomini
state: Italia
city: Catanzaro
country: Italy
facility: ASP Catanzaro
Study officials:
References: