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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05265871
Enrollment
131
Registered
2022-03-04
Start date
2022-05-16
Completion date
2024-01-24
Last updated
2025-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory/Unexplained Chronic Cough

Keywords

refractory/unexplained chronic cough, cough sensitivity, adenosine triphosphate

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.

Interventions

None listed

Sponsors

Kefang Lai
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
ATP Level in Sputum SupernatantATP concentrations were measured in all specimens on the day of the last participant's enrollment.ATP level in induced sputum in patients with refractory/unexplained chronic cough and healthy control

Secondary

MeasureTime frameDescription
ATP Cough SensitivityEach subject underwent ATP cough challenge on the day of enrollment.Cough sensitivity for ATP in patients with refractory/unexplained chronic cough and healthy control. Lowest concentration of ATP that provoked at least 5 coughs (C5) is used to indicate cough sensitivity.

Countries

China

Participant flow

Participants by arm

ArmCount
Patients With Refractory/Unexplained Chronic Cough
Patients with RCC/UCC were recruited in the Cough Clinic at the First Affiliated Hospital of Guangzhou Medical University from May 2022 to January 2024. 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. 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).
101
Healthy Controls
Healthy control (≥18 years old) are included, who are age and gender marched with patients. 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
30
Total131

Baseline characteristics

CharacteristicHealthy ControlsTotalPatients With Refractory/Unexplained Chronic Cough
Age, Continuous42.6 years
STANDARD_DEVIATION 10.8
40.6 years
STANDARD_DEVIATION 12.6
40.1 years
STANDARD_DEVIATION 13.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
30 Participants131 Participants101 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
14 Participants68 Participants54 Participants
Sex: Female, Male
Male
16 Participants63 Participants47 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

ATP Level in Sputum Supernatant

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

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

ArmMeasureValue (MEAN)
Patients With Refractory/Unexplained Chronic CoughATP Level in Sputum Supernatant2313.4 pM
Healthy ControlATP Level in Sputum Supernatant1804.6 pM
Secondary

ATP Cough Sensitivity

Cough sensitivity for ATP in patients with refractory/unexplained chronic cough and healthy control. Lowest concentration of ATP that provoked at least 5 coughs (C5) is used to indicate cough sensitivity.

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

ArmMeasureValue (MEAN)
Patients With Refractory/Unexplained Chronic CoughATP Cough Sensitivity3.16 mM
Healthy ControlATP Cough Sensitivity316 mM

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026