Gender Differences and SNPs in Asthmatic Patients
1 other identifier
observational
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 11, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedNovember 23, 2020
November 1, 2020
1.3 years
September 11, 2020
November 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Expression of SNPs
statistically significant difference (P\<0.05) in SNPs expression between male and female
1 month
Secondary Outcomes (2)
Concentration of MicroRNA
1 month
SNPs and age
1 month
Study Arms (2)
Male-group
in this group we will enroll only male with asthma
Female-group
in this group we will enroll only female with asthma
Interventions
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.
Using the sampe of blood (3 mL) using RT-PCR we will evaluate the expression of microRNA in enrolled patients
Eligibility Criteria
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
You may qualify if:
- asthma (allergic or not) diagnosed according to Global Initiative for Asthma guidelines (GINA 2020).
- signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
AO Materdomini
Catanzaro, Italia, 88100, Italy
ASP Catanzaro
Catanzaro, 88100, Italy
Biospecimen
we will take the oral swab in order to evaluate the enzyme expression
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
September 11, 2020
First Posted
September 28, 2020
Study Start
August 1, 2020
Primary Completion
November 20, 2021
Study Completion
December 30, 2021
Last Updated
November 23, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share