Allergic AsthmaNCT04567212
Gender Differences and SNPs in Asthmatic Patients
An observational study of Allergic Asthma and Asthma, run by University of Catanzaro at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Asthma, Asthma
- What is being tested?
- genetic evaluation and MicroRNA evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Aug 2020to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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
Who may be able to join
- asthma (allergic or not) diagnosed according to Global Initiative for Asthma guidelines (GINA 2020).
- signed informed consent
Who cannot join
- • 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)
Show all 9Show fewer
- substanceabuse
- inability to give written informed consent
- those who will not sign the consent to the processing of personal data
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
AO Materdomini
Catanzaro, Italia, 88100
Luca Gallelli, MD, +390961712537, gallelli@unicz.it
- Recruiting
ASP Catanzaro
Catanzaro, 88100
Antonio Guerra, MD, 3398199190, guerra.antonio@simg.it
Antonio Scuteri, MD
About this study
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.
Read the 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.
- Conditions
- Allergic Asthma, Asthma
- Being tested
- genetic evaluation, MicroRNA evaluation
- Keywords
- asthma, allergy, Gender, polymorphism
- Medical subject headings
- Asthma, Hypersensitivity, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic evaluationGenetic
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.
MicroRNA evaluationOther
Using the sampe of blood (3 mL) using RT-PCR we will evaluate the expression of microRNA in enrolled patients
| Study group | Role | What they receive |
|---|---|---|
| Male-group | in this group we will enroll only male with asthma Receives: Genetic: genetic evaluation; Other: MicroRNA evaluation | |
| Female-group | in this group we will enroll only female with asthma Receives: Genetic: genetic evaluation; Other: MicroRNA evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of SNPs
statistically significant difference (P<0.05) in SNPs expression between male and female
Measured: 1 month
Secondary outcomes (2)
Concentration of MicroRNA
statistically significant difference (P<0.05) in microRNA between male and female
Measured: 1 month
SNPs and age
statistically significant difference (P<0.05) in SNPs expression between age > 12 years and < 12 years
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Aug 2020
- Primary completion20 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria Provinciale Di Catanzaro, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Responsible party
- Principal investigator, Luca Gallelli, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567212
- Sponsor's protocol ID
- SNPS asthma
- Status last verified
- Nov 2020
- First submitted
- 11 Sep 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences and SNPs in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT04567212
- Acronym / sponsor ID
- SNPS asthma
- Conditions
- Allergic Asthma, Asthma
- Keywords
- asthma, allergy, Gender, polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Collaborators
- Azienda Sanitaria Provinciale Di Catanzaro, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 20 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male-group | – | Genetic: genetic evaluation, Other: MicroRNA evaluationin this group we will enroll only male with asthma |
| Female-group | – | Genetic: genetic evaluation, Other: MicroRNA evaluationin this group we will enroll only female with asthma |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (2 listed)
- asthma (allergic or not) diagnosed according to Global Initiative for Asthma guidelines (GINA 2020).
- signed informed consent
Key exclusion criteria (9 listed)
- • infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic evaluationA 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. | Genetic | Female-group, Male-group |
| MicroRNA evaluationUsing the sampe of blood (3 mL) using RT-PCR we will evaluate the expression of microRNA in enrolled patients | Other | Female-group, Male-group |
Primary outcome
Expression of SNPs
Time frame: 1 month
statistically significant difference (P<0.05) in SNPs expression between male and female
2 secondary outcomes
Concentration of MicroRNA
Time frame: 1 month
SNPs and age
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Asthma and Asthma, run by University of Catanzaro at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of SNPs (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020; AzTrials last refreshed its copy on 30 Oct 2026.