Exhaled Breath Condensate Biomarkers in CARAS

August 27, 2024 updated by: Henan University of Traditional Chinese Medicine

Preliminary Application and Evaluation of Exhaled Breath Condensate Biomarkers in Combined Allergic Rhinitis and Asthma Syndrome (CARAS)

To explore the differences in the expression of biomarkers in different sample types between the healthy population and different subgroups of the disease, and to screen for potential biomarkers in a more simple, direct and objective way. To screen the biomarkers that can be identified by CARAS Chinese medicine symptoms and different stages, and to provide a reference basis for individualised diagnosis and treatment of the disease.

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhengzhou
      • Henan, Zhengzhou, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Chinese Medicine
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Allergic rhinitis (AR) is a common chronic inflammatory disease of the upper respiratory tract with paroxysmal sneezing, nasal congestion, watery nasal discharge and nasal itching as the main clinical symptoms. Bronchial asthma (BA) is a complex heterogeneous chronic inflammatory disease of the bronchi with recurrent symptoms of wheezing, shortness of breath, chest tightness, and coughing.AR usually coexists with BA, and about 70-90% of patients with asthma develop rhinitis, and about 40% of patients with rhinitis develop asthma. When AR and BA occur together, it is called combined allergic rhinitis and asthma syndrome (CARAS).

Description

Inclusion Criteria:

  • Patients with AR, BA and CARAS who meet the Western medical diagnostic criteria;
  • Chinese medical evidence consistent with lung qi deficiency evidence, phlegm-heat congestion of the lung evidence, or wind-heat offending the lung evidence;
  • Age 18 to 80 years;
  • Voluntarily accepted the study and signed an informed consent form;
  • Not participated in other clinical studies within 1 month before enrollment.

Exclusion Criteria:

  • Patients with combined vasomotor rhinitis and eosinophilic non-allergic rhinitis, other non-allergic rhinitis diseases that can cause symptoms such as nasal congestion and runny nose;
  • Patients who are participating in other drug trials;
  • Patients with a combination of other serious systemic diseases;
  • Pregnant or lactating women;
  • Patients with confusion, disorders of consciousness, dementia, and various psychiatric disorders.

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.
acute exacerbation CARAS
Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
Other: questionnaire survey
subjects fill out questionnaires
chronic persistence CARAS
Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
Other: questionnaire survey
subjects fill out questionnaires
clinical control CARAS
Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
Other: questionnaire survey
subjects fill out questionnaires
acute exacerbation BA
Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
Other: questionnaire survey
subjects fill out questionnaires
chronic persistence BA
Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
Other: questionnaire survey
subjects fill out questionnaires
clinical control BA
Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
Other: questionnaire survey
subjects fill out questionnaires
intermittent AR
Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
Other: questionnaire survey
subjects fill out questionnaires
persistent AR
Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
Other: questionnaire survey
subjects fill out questionnaires
healthy individuals
Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
Other: questionnaire survey
subjects fill out questionnaires

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
Interleukin-2、4、5、13 (IL-2、4、5、13)
Time Frame: Basline
Airway inflammation will be assessed using the IL-2、4、5、13.
Basline
Interferon-γ (IFN-γ)
Time Frame: Basline
Airway inflammation will be assessed using the IFN-γ.
Basline
Tumor necrosis factor-β (TNF-β)
Time Frame: Basline
Airway inflammation will be assessed using the TNF-β.
Basline
Eosinophil cationic proteins (ECP)
Time Frame: Basline
Airway inflammation will be assessed using the ECP.
Basline
Immunoglobulin E (IgE)
Time Frame: Basline
Airway inflammation will be assessed using the IgE.
Basline

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
Fractional exhaled nitric oxide (FeNO)
Time Frame: Basline
Higher FeNO values indicate higher airway inflammation.
Basline
Forced expiratory volume in one second (FEV1)
Time Frame: Basline
Lung function will be assessed using the FEV1.
Basline
Forced vital capacity (FVC)
Time Frame: Basline
Lung function will be assessed using the FEV1.
Basline
FVC as the percentage of the predicted value (FVC%)
Time Frame: Basline
Lung function will be assessed using the FVC%.
Basline
Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)
Time Frame: Basline
Lung function will be assessed using the FEV1/FVC.
Basline

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.
Henan University of Traditional Chinese Medicine

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.
April 1, 2023

Primary Completion (Estimated)

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.
May 30, 2025

Study Completion (Estimated)

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.
May 30, 2025

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).
August 21, 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.
August 23, 2024

First Posted (Actual)

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.
August 27, 2024

Study Record Updates

Last Update Posted (Actual)

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.
August 28, 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.
August 27, 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.
August 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.
  • EBC biomarkers in CARAS

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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