Clinical trial NCT05265871: ATP Level and Cough Sensitivity to ATP in Subjects With Refractory/Unexplained Chronic Cough
Official title: ATP Level in Induced Sputum and Cough Sensitivity to ATP in Subjects With Refractory/Unexplained Chronic Cough
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory/Unexplained Chronic Cough
Keywords: refractory/unexplained chronic cough
cough sensitivity
adenosine triphosphate
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: Inclusion criteria for patients:

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 for patients:

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).

Healthy control aged ≥18 years old are included. Exclusion criteria are as follow:

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

Primary outcomes:
measure: ATP Level in Sputum Supernatant
timeFrame: ATP concentrations were measured in all specimens on the day of the last participant's enrollment.
Secondary outcomes:
measure: ATP Cough Sensitivity
timeFrame: Each subject underwent ATP cough challenge on the day of enrollment.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: 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
state: Guangdong
Study officials:
affiliation: 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
name: Kefang Lai, MD, PhD
role: STUDY_CHAIR
References: