Refractory/Unexplained Chronic CoughNCT05265871
ATP Level and Cough Sensitivity to ATP in Subjects With Refractory/Unexplained Chronic Cough
An observational study of Refractory/Unexplained Chronic Cough, run by Kefang Lai at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractory/Unexplained Chronic Cough
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2022to 24 Jan 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- ≥18 years old
- cough as sole symptom lasting ≥6 months
- cough visual analogue score ≥30mm
- diagnosed as RCC/UCC according to guidelines
Who cannot join
- 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).
- Healthy control aged ≥18 years old are included. Exclusion criteria are as follow:
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
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
About this study
Official title: ATP Level in Induced Sputum and Cough Sensitivity to ATP in Subjects With Refractory/Unexplained Chronic Cough
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATP Level in Sputum Supernatant
ATP level in induced sputum in patients with refractory/unexplained chronic cough and healthy control
Measured: ATP concentrations were measured in all specimens on the day of the last participant's enrollment.
Secondary outcomes (1)
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.
Measured: Each subject underwent ATP cough challenge on the day of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start16 May 2022
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory/Unexplained Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kefang Lai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Kefang Lai, MD, PhD, Study chair, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265871
- Sponsor's protocol ID
- RCC-ATP
- Status last verified
- Apr 2025
- First submitted
- 23 Feb 2022
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATP Level in Induced Sputum and Cough Sensitivity to ATP in Subjects With Refractory/Unexplained Chronic Cough
- ClinicalTrials.gov ID
- NCT05265871
- Acronym / sponsor ID
- RCC-ATP
- Conditions
- Refractory/Unexplained Chronic Cough
- Keywords
- refractory/unexplained chronic cough, cough sensitivity, adenosine triphosphate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Kefang LaiUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- ≥18 years old
- cough as sole symptom lasting ≥6 months
- cough visual analogue score ≥30mm
- diagnosed as RCC/UCC according to guidelines
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ATP Level in Sputum Supernatant
Time frame: 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
1 secondary outcome
ATP Cough Sensitivity
Time frame: Each subject underwent ATP cough challenge on the day of enrollment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kefang Lai, MD, PhD study chair
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory/Unexplained Chronic Cough, run by Kefang Lai at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ATP Level in Sputum Supernatant (time frame: ATP concentrations were measured in all specimens on the day of the last participant's enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.