Gender Differences and SNPs in Asthmatic Patients | NCT04567212

Studies
Gender Differences and SNPs in Asthmatic Patients

NCT04567212

Sponsor

University of Catanzaro

Status

Unknown status

Last Update Posted

Nov 23, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Allergic Asthma
Asthma

Interventions

genetic evaluation
MicroRNA evaluation

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Nov 20, 2021Estimated

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Sep 11, 2020

First Submission Date that Met QC Criteria

Sep 22, 2020

First Posted Date

Sep 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2020

Last Update Posted Date

Nov 23, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luca Gallelli, MD PhD, University of CatanzaroPrincipal Investigator

Lead Sponsor

University of CatanzaroOTHER

Collaborators

Name	Class
Azienda Sanitaria Provinciale Di Catanzaro	OTHER
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Male-group		in this group we will enroll only male with asthma	Genetic: genetic evaluation Other: MicroRNA evaluation
Female-group		in this group we will enroll only female with asthma	Genetic: genetic evaluation Other: MicroRNA evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
genetic evaluation	Genetic	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression of SNPs	statistically significant difference (P<0.05) in SNPs expression between male and female	1 month

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AO Materdomini	Recruiting	Catanzaro	Italia	88100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D006967	Hypersensitivity
D003075	Coitus

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided