ATP Level and Cough Sensitivity to ATP in Subjects With Refractory/Unexplained Chronic Cough

NCT ID: NCT05265871

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 131 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2024-01-24

Brief Summary

This is a cross-sectional study to investigate ATP level in induced sputum and cough sensitivity to ATP in subjects with refractory/unexplained chronic cough. 60 patients with refractory/unexplained chronic cough and 30 matched healthy controls were recruited. Demographic data, clinical characteristic, cough sacles and medical history records were collected. Cough chanllage(ATP and capsaicin) and ATP measurement in sputum were conducted.The difference of sputum ATP level between patients and control and the correlation between sputum ATP level and cough sensitivity to ATP were analyzed.

Conditions

Refractory/Unexplained Chronic Cough

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

refractory/unexplained chronic cough

Induced sputum test and cough challenge(ATP and capsaicin) were performed.

No interventions assigned to this group

Healthy control

Induced sputum test and cough challenge(ATP and capsaicin ) were performed.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. ≥18 years old

2. cough as sole symptom lasting ≥6 months

3. cough visual analogue score ≥30mm

4. diagnosed as RCC/UCC according to guidelines

Exclusion Criteria

1. smoking currently or in the past 6 months, or a smoking history of >20 pack-year

2. a forced expiratory volume in 1 second/forced vital capacity ratio <70%;

3. use of inhaled/oral corticosteroid, bronchodilators, anti-allergic medicine, antitussive medicine or anti-reflux treatment in the past 1 week;

4. a history of acute respiratory infection in the past 4 weeks;

5. a history of severe disease (cancer, acute coronary syndrome and so on).

1. smoking currently or in the past 6 months, or a smoking history of >20 pack-year

2. a forced expiratory volume in 1 second/forced vital capacity ratio <70%

3. a history of acute respiratory infection in the past 4 weeks

4. posstive findings of chest radiography

5. a history of chronic respiratory disease and allergic disease

6. any signs of cough hypersensitivity

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kefang Lai

OTHER

Sponsor Role: lead

Responsible Party

Kefang Lai

Director of Clinical Research Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kefang Lai, MD, PhD

Role: STUDY_CHAIR

Guangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, The First Affiliated Hospital of Guangzhou Medical University

Locations

Guangzhou Institute of Respiratory Health, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RCC-ATP

Identifier Type: -

Identifier Source: org_study_id