Trial Outcomes & Findings for ATP Level and Cough Sensitivity to ATP in Subjects With Refractory/Unexplained Chronic Cough (NCT NCT05265871)
NCT ID: NCT05265871
Last Updated: 2025-05-11
Results Overview
ATP level in induced sputum in patients with refractory/unexplained chronic cough and healthy control
Recruitment status
COMPLETED
Target enrollment
131 participants
Primary outcome timeframe
ATP concentrations were measured in all specimens on the day of the last participant's enrollment.
Results posted on
2025-05-11
Participant Flow
Participant milestones
| Measure |
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).
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
30
|
|
Overall Study
COMPLETED
|
101
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ATP Level and Cough Sensitivity to ATP in Subjects With Refractory/Unexplained Chronic Cough
Baseline characteristics by cohort
| Measure |
Patients With Refractory/Unexplained Chronic Cough
n=101 Participants
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).
|
Healthy Controls
n=30 Participants
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
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
101 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ATP 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
Outcome measures
| Measure |
Patients With Refractory/Unexplained Chronic Cough
n=96 Participants
Induced sputum test and cough challenge(ATP and capsaicin) were performed.
|
Healthy Control
n=25 Participants
Induced sputum test and cough challenge(ATP and capsaicin ) were performed.
|
|---|---|---|
|
ATP Level in Sputum Supernatant
|
2313.4 pM
Interval 1312.3 to 4633.8
|
1804.6 pM
Interval 1237.3 to 5276.2
|
SECONDARY outcome
Timeframe: Each 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.
Outcome measures
| Measure |
Patients With Refractory/Unexplained Chronic Cough
n=101 Participants
Induced sputum test and cough challenge(ATP and capsaicin) were performed.
|
Healthy Control
n=30 Participants
Induced sputum test and cough challenge(ATP and capsaicin ) were performed.
|
|---|---|---|
|
ATP Cough Sensitivity
|
3.16 mM
Interval 0.316 to 31.6
|
316 mM
Interval 31.6 to 316.0
|
Adverse Events
Patients With Refractory/Unexplained Chronic Cough
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kefang Lai
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
Phone: 18928868231
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place