Clinical trial NCT06862362: China Chronic Cough Registry: a Multicenter, Prospective, Observational Study
Official title: China Chronic Cough Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Cough (CC)
Keywords: chronic cough
registry
clinical data
biosample
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic cough visiting the respiratory clinic or hospitalized.

Brief summary: 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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Baseline demographics, clinical and pathophysiologic characteristics of the total patients in the chronic cough cohort
timeFrame: After 6000 patients entry at baselin
measure: The prognosis of chronic cough in a real-word clinic
timeFrame: From baseline to the end of follow-up at the second year
measure: Identifing phenotypes and endotypes, based on biomarkers and/or clinical parameters.
timeFrame: After baseline entry and At the first or second year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affliated hospital of Guangzhou Medical University
name: Kefang Lai, PhD
role: PRINCIPAL_INVESTIGATOR
References: