- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04567212
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
-
-
-
Catanzaro, Italy, 88100
- Recruiting
- ASP Catanzaro
-
Contact:
- Antonio Guerra, MD
- Phone Number: 3398199190
- Email: guerra.antonio@simg.it
-
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
|
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
|
Female-group
in this group we will enroll only female with asthma
|
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
|
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.
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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