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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Each subject underwent ATP cough challenge on the day of enrollment. |
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Inclusion criteria for patients:
Exclusion criteria for patients:
Healthy control aged ≥18 years old are included. Exclusion criteria are as follow:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
Exclusion criteria for patients:
|
| FG001 | Healthy Controls | Healthy control (≥18 years old) are included, who are age and gender marched with patients. Exclusion criteria are as follow:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
Exclusion criteria for patients:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ATP Level in Sputum Supernatant | ATP level in induced sputum in patients with refractory/unexplained chronic cough and healthy control | Posted | Mean | Inter-Quartile Range | pM | ATP concentrations were measured in all specimens on the day of the last participant's enrollment. |
|
This study mainly involves induced sputum test and cough challenge without any interventional design. Induced sputum test and cough challenge are received as safe and widely used in clinics or researches. Therefore, observation of adverse event has not been designed.
All-Cause mortality, serious, and other [Not Including Serious] adverse events were not monitored, so total number of participants at risk for adverse events is zero.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
Exclusion criteria for patients:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 | 18928868231 | klai@vip.163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 25, 2025 | Apr 25, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2025 | Apr 25, 2025 | SAP_001.pdf |
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sputum supernate (without DNA)
| China |
| BG001 | Healthy Controls | Healthy control (≥18 years old) are included, who are age and gender marched with patients. Exclusion criteria are as follow:
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Mean | Inter-Quartile Range | mM | Each subject underwent ATP cough challenge on the day of enrollment. |
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Healthy Controls | Healthy control (≥18 years old) are included, who are age and gender marched with patients. Exclusion criteria are as follow:
| 0 | 0 | 0 | 0 | 0 | 0 |
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