Causal Associations Between Allergic Rhinitis and Asthma

October 31, 2024 updated by: Zhibin Xu

Bidirectional Mendelian Randomization Study Reveals Causal Associations Between Allergic Rhinitis and Asthma

This study investigates the causal relationship between allergic rhinitis and asthma using a bidirectional two-sample Mendelian randomization approach. Genetic data were derived from UK Biobank for allergic rhinitis and from Finnish biobank for asthma. This analysis aims to clarify the potential causal link between these two conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This observational study utilizes a bidirectional two-sample Mendelian randomization (MR) analysis to examine the causal association between allergic rhinitis and asthma. The genetic data for allergic rhinitis were obtained from the UK Biobank, encompassing 18,934 cases and 64,595 controls, while asthma data were derived from a Finnish biobank, including 20,629 cases and 135,449 controls. The Mendelian randomization analysis was performed using inverse-variance weighting (IVW), Mendelian randomization-Egger (MR-Egger), and weighted median methods to ensure robust causal inference. Additional tests, such as Cochrane's Q test and Mendelian randomization pleiotropy residual sum and outlier (MR-PRESSO), were applied to assess heterogeneity and pleiotropy, enhancing the reliability of the findings. The results are expected to provide insights into the bidirectional causal relationship between allergic rhinitis and asthma, potentially informing future prevention and treatment strategies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
239607

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This study includes individuals diagnosed with allergic rhinitis or asthma from the UK Biobank and Finnish biobank databases.

Description

Inclusion Criteria:

  • Individuals diagnosed with allergic rhinitis or asthma.
  • Availability of genetic data in the UK Biobank or Finnish biobank.

Exclusion Criteria:

  • Individuals without genetic data.
  • Participants with incomplete phenotype or genotype 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Allergic Rhinitis Cohort
This cohort consists of individuals with allergic rhinitis and a control group from the UK Biobank database, including 18,934 cases of allergic rhinitis and 64,595 controls. Genetic data were used to explore causal relationships with asthma.
Other: Mendelian Randomization
This study utilizes a bidirectional Mendelian randomization approach to analyze genetic data from individuals with allergic rhinitis and asthma. No active intervention is applied; genetic variants serve as instrumental variables to assess causal associations between the conditions.
Asthma Cohort
This cohort includes individuals with asthma and a control group from the Finnish biobank database, consisting of 20,629 cases of asthma and 135,449 controls. Genetic data were analyzed to examine causal associations with allergic rhinitis.
Other: Mendelian Randomization
This study utilizes a bidirectional Mendelian randomization approach to analyze genetic data from individuals with allergic rhinitis and asthma. No active intervention is applied; genetic variants serve as instrumental variables to assess causal associations between the conditions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Causal Effect of Allergic Rhinitis on Asthma Risk
Time Frame: Oct 24 2024
Estimate the causal effect of allergic rhinitis on asthma risk using bidirectional Mendelian randomization. This measure includes odds ratios (OR) derived from inverse-variance weighting (IVW), Mendelian randomization-Egger (MR-Egger), and weighted median methods.
Oct 24 2024
Causal Effect of Asthma on Allergic Rhinitis Risk
Time Frame: Oct 24 2024
Estimate the causal effect of asthma on allergic rhinitis risk using bidirectional Mendelian randomization. This measure includes odds ratios (OR) derived from inverse-variance weighting (IVW), Mendelian randomization-Egger (MR-Egger), and weighted median methods.
Oct 24 2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity Analysis Using MR-Egger Intercept Test
Time Frame: Oct 24 2024
Perform sensitivity analysis using the Mendelian randomization-Egger (MR-Egger) intercept test to assess horizontal pleiotropy in the causal estimates between allergic rhinitis and asthma.
Oct 24 2024
Sensitivity Analysis Using Leave-One-Out Test
Time Frame: Oct 24 2024
Conduct a leave-one-out test to evaluate the robustness of the causal estimates between allergic rhinitis and asthma by sequentially removing each single nucleotide polymorphism (SNP).
Oct 24 2024
Sensitivity Analysis Using MR-PRESSO
Time Frame: Oct 24 2024
Use the Mendelian randomization pleiotropy residual sum and outlier (MR-PRESSO) test to detect and correct for outliers, assessing heterogeneity in the causal estimates between allergic rhinitis and asthma.
Oct 24 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhibin Xu

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings