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

NCT06862362 | Not Yet Recruiting

• 1 other identifier: ES-2025-K005-01
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Cough (CC)

Keywords

chronic cough; registry; clinical data; biosample

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients with chronic cough

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic cough visiting the respiratory clinic or hospitalized.

You may qualify if:

• 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)

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

sputum cells, sputum supernatant, PBMC, serum, urine specimens, airway mucosa and bronchoalveolar lavage fluid (BALF)

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kefang Lai, PhD

  The First Affliated hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kefang Lai, PhD

CONTACT

8134+81566841; klai@vip.163.com

Fang Yi, PhD

CONTACT

+8613544435065; upyifang@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 6, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

CN (1)