Allergic RhinitisNCT06668974
Causal Associations Between Allergic Rhinitis and Asthma
An observational study of Allergic Rhinitis and Asthma, run by Zhibin Xu at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Allergic Rhinitis, Asthma
- What is being tested?
- Mendelian Randomization
- How many people
- 239,607 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 28 Oct 2024
- 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 0 years and older
- All sexes
- Child, Adult, Older adult
Study population: This study includes individuals diagnosed with allergic rhinitis or asthma from the UK Biobank and Finnish biobank databases.
Who may be able to join
- Individuals diagnosed with allergic rhinitis or asthma.
- Availability of genetic data in the UK Biobank or Finnish biobank.
Who cannot join
- Individuals without genetic data.
- Participants with incomplete phenotype or genotype data.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: 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.
Read the 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.
- Conditions
- Allergic Rhinitis, Asthma
- Being tested
- Mendelian Randomization
- Keywords
- Mendelian Randomization, Genetic Association, Bidirectional Causality, Genome-Wide Association Study (GWAS), Respiratory Diseases
- Medical subject headings
- Rhinitis, Allergic, Asthma, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mendelian RandomizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mendelian Randomization | |
| 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. Receives: Other: Mendelian Randomization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Causal Effect of Allergic Rhinitis on Asthma Risk
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.
Measured: Oct 24 2024
Causal Effect of Asthma on Allergic Rhinitis Risk
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.
Measured: Oct 24 2024
Secondary outcomes (3)
Sensitivity Analysis Using MR-Egger Intercept Test
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.
Measured: Oct 24 2024
Sensitivity Analysis Using Leave-One-Out Test
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).
Measured: Oct 24 2024
Sensitivity Analysis Using MR-PRESSO
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.
Measured: Oct 24 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Oct 2024
- Primary completion15 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 239,607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhibin Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhibin Xu, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668974
- Sponsor's protocol ID
- GS-002
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bidirectional Mendelian Randomization Study Reveals Causal Associations Between Allergic Rhinitis and Asthma
- ClinicalTrials.gov ID
- NCT06668974
- Acronym / sponsor ID
- GS-002
- Conditions
- Allergic Rhinitis, Asthma
- Keywords
- Mendelian Randomization, Genetic Association, Bidirectional Causality, Genome-Wide Association Study (GWAS), Respiratory Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239,607 participants (actual)
- Lead sponsor
- Zhibin XuUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 1 Nov 2024 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allergic Rhinitis Cohort | – | Other: Mendelian RandomizationThis 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. |
| Asthma Cohort | – | Other: Mendelian RandomizationThis 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. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This study includes individuals diagnosed with allergic rhinitis or asthma from the UK Biobank and Finnish biobank databases.
Key inclusion criteria (2 listed)
- Individuals diagnosed with allergic rhinitis or asthma.
- Availability of genetic data in the UK Biobank or Finnish biobank.
Key exclusion criteria (2 listed)
- Individuals without genetic data.
- Participants with incomplete phenotype or genotype data.
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 |
|---|---|---|
| Mendelian RandomizationThis 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. | Other | Allergic Rhinitis Cohort, Asthma Cohort |
Primary outcome
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.
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.
3 secondary outcomes
Sensitivity Analysis Using MR-Egger Intercept Test
Time frame: Oct 24 2024
Sensitivity Analysis Using Leave-One-Out Test
Time frame: Oct 24 2024
Sensitivity Analysis Using MR-PRESSO
Time frame: Oct 24 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis and Asthma, run by Zhibin Xu at 1 site in China.
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 2 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: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Causal Effect of Allergic Rhinitis on Asthma Risk (time frame: Oct 24 2024). The study lists 2 primary outcomes in all. 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 1 Nov 2024.