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

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: Not yet recruiting
• Conditions: Chronic Cough (CC)

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: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Kefang Lai, PhD; Phone Number: 8134+81566841; Email: klai@vip.163.com
• Study Contact Backup: Name: Fang Yi, PhD; Phone Number: +8613544435065; Email: upyifang@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with chronic cough

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline demographics, clinical and pathophysiologic characteristics of the total patients in the chronic cough cohort	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	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.	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

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Kefang Lai, PhD, The First Affliated hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 23, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: registry; chronic cough; clinical data; biosample
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Chronic Cough; Cough
• Other Study ID 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