China Chronic Cough Registry: a Multicenter, Prospective, Observational Study

March 3, 2025 updated by: Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University

China Chronic Cough Cohort Study

The aim is to establish a national clinical database and biobanks for chronic coughers. Through real-world chronic cough case registry and follow-up studies, we will explore the clinical phenotypes and molecular subtypes of chronic cough.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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.

Detailed Description

There is currently no national cohort study on chronic cough in China. Preliminary researches indicated heterogeneity in the clinical phenotypes and hypersensitivity associated with chronic cough, highlighting the need to establish a large chronic cough cohort for further study. The completion of this project will provide real-world data for the management of chronic cough patients, contributing to the improvement of prevention, treatment, and management standards. It will also provide Chinese data for further refining cough guidelines. Additionally, by elucidating the phenotypes and molecular subtypes related to chronic cough, this study will be significant for identifying relevant targets to guide new drug development for chronic cough. This multicenter, prospective, observational study will enroll patients with chronic cough in a real-world clinic. Baseline information including demographics, cough characteristics, past treatment history, laboratory test results, initial diagnosis and treatment details will be recorded by using an online registration and follow-up platform. After the baseline data registration, we will conduct annual follow-ups for these patients over a period of two years. The cough prognosis and medication using history will be recorded at every follow-up. Some patients will provide biological samples such as sputum supernatant, serum, etc at baseline and follow-up. The diagnosis and treatment process for these patients is based on clinical practice/guideline standards, without any other interventions.

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.
6000

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 Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic cough visiting the respiratory clinic or hospitalized.

Description

Inclusion Criteria:

  • Is over 18 years old
  • Cough as the sole or main symptom
  • Has cough lasting more than 8 weeks
  • No obvious findings of Chest X-ray / Chest CT
  • Has no other evident diagnoses (e.g. IPF, NCFB, COPD, bronchiectasis, lung cancer)
  • Has given signed consent for inclusion in the study

Exclusion Criteria:

-

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.
Patients with chronic cough

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
Baseline demographics, clinical and pathophysiologic characteristics of the total patients in the chronic cough cohort
Time Frame: After 6000 patients entry at baselin
The demographics, and clinical characteristics included age, sex, BMI, smoking history, cough triggers, cough timing, cough complications and associated symptoms, comorbidities, previous treatment and response, cough severity outcomes evaluated by questionnaires including cough VAS, urge to cough VAS, CET, LCQ. Blood eosinophils counting, lung function and FeNO measurements were performed and recorded.
After 6000 patients entry at baselin
The prognosis of chronic cough in a real-word clinic
Time Frame: From baseline to the end of follow-up at the second year
Elucidating the prognosis of the total patients after 2 yeas follow-up. Cough relief will be reported by patients-self and risk factors for patients with persistent cough will be investigated. After 2 years from the baseline, patients will be visited at clinic or through telephone, cough VAS, urge to cough VAS, CET and LCQ will be completed. Identifying the risk factors for patients with persistent cough by analyzing the demographic information and baseline clinical characteristics including cough duration, comorbidities, accompanying symptoms, airway inflammation biomarkers and treatment situations during the follow-up period, etc.
From baseline to the end of follow-up at the second year
Identifing phenotypes and endotypes, based on biomarkers and/or clinical parameters.
Time Frame: After baseline entry and At the first or second year follow-up
To elucidate the potential phenotypes and endotypes of chronic cough, demographics, baseline clinical characteristics including cough duration, cough triggers, cough timing, cough complications and associated symptoms, comorbidities etc., cough severity evaluated by cough VAS, urge to cough VAS, CET and LCQ and baseline diagnostic tests including lung function, FeNO, blood routine tests will be analyzed. Cough relief status also will be recorded during the annual follow-up. Further more, biological samples including peripheral blood mononuclear cells (PBMC), serum, sputum samples including sputum supernatant, sputum cells and urine were collected from a subset of patients at baseline and at the 1-year follow-up. For some patients with refractory chronic cough, additional biological specimens such as airway mucosa and bronchoalveolar lavage fluid will be collected. These samples will undergo transcriptomics, metagenomics, proteomics, metabolomics, whole exome sequencing, single-cell AT
After baseline entry and At the first or second year follow-up

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.
The First Affiliated Hospital of Guangzhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kefang Lai, PhD, The First Affliated hospital of Guangzhou Medical University

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 (Estimated)

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.
May 1, 2025

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.
December 31, 2026

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.
December 31, 2028

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).
February 23, 2025

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.
March 3, 2025

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.
March 25, 2025

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.
March 25, 2025

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.
March 3, 2025

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.
March 1, 2025

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.
  • ES-2025-K005-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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