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

NCT05265871 | Completed Results

• 1 other identifier: RCC-ATP
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

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

Keywords

refractory/unexplained chronic cough; cough sensitivity; adenosine triphosphate

Outcome Measures

Primary Outcomes (1)

• ATP Level in Sputum Supernatant

  ATP level in induced sputum in patients with refractory/unexplained chronic cough and healthy control

  ATP concentrations were measured in all specimens on the day of the last participant's enrollment.

Secondary Outcomes (1)

• ATP Cough Sensitivity

  Each subject underwent ATP cough challenge on the day of enrollment.

Study Arms (2)

refractory/unexplained chronic cough

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

Healthy control

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

Eligibility Criteria

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

Study Population

Subjects with chronic cough visiting cough clinics at the First Affiliated Hospital of Guangzhou Medical University would all be screened by the investigator. To be specific, RCC/UCC refers to a chronic cough: 1) without identifiable causes after throughout investigation; 2) persistent after empirical treatment to known causes; 3) persistent after treatment for positive conditions known to be associated with chronic cough. Age and gender matched healthy controls would be recruited. The subject who meets the criteria and provides written informed consent is considered as eligible and enrolled into the study.

You may qualify if:

• ≥18 years old
• cough as sole symptom lasting ≥6 months
• cough visual analogue score ≥30mm
• diagnosed as RCC/UCC according to guidelines

You may not qualify if:

• smoking currently or in the past 6 months, or a smoking history of \>20 pack-year
• a forced expiratory volume in 1 second/forced vital capacity ratio \<70%;
• use of inhaled/oral corticosteroid, bronchodilators, anti-allergic medicine, antitussive medicine or anti-reflux treatment in the past 1 week;
• a history of acute respiratory infection in the past 4 weeks;
• a history of severe disease (cancer, acute coronary syndrome and so on).
• smoking currently or in the past 6 months, or a smoking history of \>20 pack-year
• a forced expiratory volume in 1 second/forced vital capacity ratio \<70%
• a history of acute respiratory infection in the past 4 weeks
• posstive findings of chest radiography
• a history of chronic respiratory disease and allergic disease
• any signs of cough hypersensitivity

Sponsors & Collaborators

• Kefang Lai: lead

Study Sites (1)

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum supernate (without DNA)

Results Point of Contact

• Title: Kefang Lai
• Organization: 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

klai@vip.163.com

18928868231

Study Officials

• Kefang Lai, MD, PhD

  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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Clinical Research Department

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: May 16, 2022
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-04

Locations

CN (1)