Chronic CoughNCT03638063
ATP and Capsaicin Cough Provocation Test in Chronic Cough and Bronchiectasis
An observational study of Chronic Cough and Bronchiectasis, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
This is a randomized, cross-over, single-blind trial. Eligible patients will be randomly assigned to undergo either capsaicin or adenosine triphosphate (ATP) cough provocation test, followed by a washout period of 2 to 14 days. Participants will be crossed-over to undergo another cough provocation test. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Cough, Bronchiectasis
- What is being tested?
- Adenosine Triphosphate and capsaicin
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2018to Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patients with chronic cough (including bronchiectasis) who remained clinically stable for at least 4 weeks
Who may be able to join
- Out-patients of either gender, ex- or never-smokers, aged between 18 and 60 years
- Cough symptoms lasting for more than 8 weeks
- Remaining free of acute upper respiratory tract infection for at least 4 weeks
- Agreed to participate in the trial and signed informed consent.
Who cannot join
- Patients with serious systemic diseases (such as malignant tumors), bullae, severe uncontrolled asthma, and a history of major hemoptysis
- Systemic antibiotic use (except for maintenance low-dose macrolides) within 4 weeks
- Pregnancy or lactation
- Any known history of sensitivity to ATP or capsaicin
- Poor understanding of the test procedure
- Diagnosed with cough variant asthma or Eosinophilic bronchitis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Wei-jie Guan, battery203@163.com
Ke-fang Lai, klai@163.com
About this study
Official title: Adenosine Triphosphate and Capsaicin Cough Provocation Test for Identifing Patients With Chronic Cough Who Have Differential Responses to Purinergic Receptor Antagonists: a Randomized, Cross-over, Single-blind Trial
This is a randomized, cross-over, single-blind trial. Eligible patients will be randomly assigned to undergo either capsaicin or adenosine triphosphate (ATP) cough provocation test, followed by a washout period of 2 to 14 days. Participants will be crossed-over to undergo another cough provocation test. Patient would be under observation in the out-patient clinics for ~2 hours following the cough provocation tests in case of severe adverse events.
Read the detailed description
This is a randomized, cross-over, single-blind trial. After verification of the entry criteria, eligible patients will be, based on the randomization codes, randomly assigned to undergo either capsaicin or ATP cough provocation test (the participants will inhale capasaicin or ATP incremental concentration to induce cough, meanwhile the number of coughs and adverse events will be recorded in each concentration during the first 30 seconds), followed by a washout period of 2 to 14 days (no major changes in the use of concomitant medications are allowed,especially the medcines which are not allowed before test ). Participants will be crossed-over to undergo another cough provocation test. Patient would be under observation in the out-patient clinics for ~2 hours following the cough provocation tests in case of severe adverse events. Twenty four hours after each test, a follow-up telephone visit will be scheduled for all patients to record any response which may be related to the test.
- Conditions
- Chronic Cough, Bronchiectasis
- Being tested
- Adenosine Triphosphate, capsaicin
- Keywords
- Adenosine triphosphate, Capsaicin, cough provocation test
- Medical subject headings
- Chronic Cough, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenosine TriphosphateDiagnostic test
Adenosine Triphosphate aerosol
capsaicinDiagnostic test
capsaicin aerosol
| Study group | Role | What they receive |
|---|---|---|
| Chronic cough | patients with chronic cough who remain clinically stable Receives: Diagnostic Test: Adenosine Triphosphate; Diagnostic Test: capsaicin | |
| Bx | bronchiectasis patients who remain clinically stable Receives: Diagnostic Test: Adenosine Triphosphate; Diagnostic Test: capsaicin | |
| Control | healthy controls Receives: Diagnostic Test: Adenosine Triphosphate; Diagnostic Test: capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
C5 (Provocant concentration eliciting at least 5 coughs)
Provocant concentration eliciting at least 5 coughs
Measured: 18 months
Secondary outcomes (6)
ED50 (half maximal effective Dose)
50% effective dose of provocant
Measured: 18 months
Emax (effective concentration of provocant eliciting maximal cough count)
effective concentration of provocant eliciting maximal cough count
Measured: 18 months
potency ratio
ATP/capsaicin potency ratio
Measured: 18 months
Difference in cough VAS score (a 10-point likert scale for assessing the global severity of cough, no subscale was applied)
The difference between pre- and post-challenge cough VAS scores
Measured: 18 months
The incidence of adverse events (i.e. dry throat , pharyngeal itching)
adverse events such as dry throat , pharyngeal itching, wheeze or dyspnea according to the subject's reporting to record the rate of the incidence and the severity (the aboved-mentioned VAS score would be applied)
Measured: 18 months
Cough dose ratio (CDR)
the ratio of cough count and dose/concentration
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start29 Oct 2018
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijie Guan, Guangzhou Institute of Respiratory Disease
- Investigators
- Ke-fang Lai, MD, Study chair, Guangzhou Institute of Respiratory Health Locations: China, Guangdong First Affiliated Hospital of Guangzhou Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638063
- Sponsor's protocol ID
- GuangzhouIRD01
- Status last verified
- Feb 2020
- First submitted
- 13 Aug 2018
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fowles HE, Rowland T, Wright C, Morice A. Tussive challenge with ATP and AMP: does it reveal cough hypersensitivity? Eur Respir J. 2017 Feb 8;49(2):1601452. doi: 10.1183/13993003.01452-2016. Print 2017 Feb.
PubMed 28179439Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Capsaicin cough sensitivity and the association with clinical parameters in bronchiectasis. PLoS One. 2014 Nov 19;9(11):e113057. doi: 10.1371/journal.pone.0113057. eCollection 2014.
PubMed 25409316Torrego A, Haque RA, Nguyen LT, Hew M, Carr DH, Wilson R, Chung KF. Capsaicin cough sensitivity in bronchiectasis. Thorax. 2006 Aug;61(8):706-9. doi: 10.1136/thx.2005.049767. Epub 2006 Apr 6.
PubMed 16601085Fuller RW. Cough provocation tests: their clinical value. Pulm Pharmacol Ther. 2002;15(3):273-6. doi: 10.1006/pupt.2002.0355.
PubMed 12099777
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenosine Triphosphate and Capsaicin Cough Provocation Test for Identifing Patients With Chronic Cough Who Have Differential Responses to Purinergic Receptor Antagonists: a Randomized, Cross-over, Single-blind Trial
- ClinicalTrials.gov ID
- NCT03638063
- Acronym / sponsor ID
- GuangzhouIRD01
- Conditions
- Chronic Cough, Bronchiectasis
- Keywords
- Adenosine triphosphate, Capsaicin, cough provocation test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
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 randomized, cross-over, single-blind trial. Eligible patients will be randomly assigned to undergo either capsaicin or adenosine triphosphate (ATP) cough provocation test, followed by a washout period of 2 to 14 days. Participants will be crossed-over to undergo another cough provocation test. Patient would be under observation in the out-patient clinics for ~2 hours following the cough provocation tests in case of severe adverse events.
Detailed description
This is a randomized, cross-over, single-blind trial. After verification of the entry criteria, eligible patients will be, based on the randomization codes, randomly assigned to undergo either capsaicin or ATP cough provocation test (the participants will inhale capasaicin or ATP incremental concentration to induce cough, meanwhile the number of coughs and adverse events will be recorded in each concentration during the first 30 seconds), followed by a washout period of 2 to 14 days (no major changes in the use of concomitant medications are allowed,especially the medcines which are not allowed before test ). Participants will be crossed-over to undergo another cough provocation test. Patient would be under observation in the out-patient clinics for ~2 hours following the cough provocation tests in case of severe adverse events. Twenty four hours after each test, a follow-up telephone visit will be scheduled for all patients to record any response which may be related to the test.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic cough | – | Diagnostic Test: Adenosine Triphosphate, Diagnostic Test: capsaicinpatients with chronic cough who remain clinically stable |
| Bx | – | Diagnostic Test: Adenosine Triphosphate, Diagnostic Test: capsaicinbronchiectasis patients who remain clinically stable |
| Control | – | Diagnostic Test: Adenosine Triphosphate, Diagnostic Test: capsaicinhealthy controls |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients with chronic cough (including bronchiectasis) who remained clinically stable for at least 4 weeks
Key inclusion criteria (4 listed)
- Out-patients of either gender, ex- or never-smokers, aged between 18 and 60 years
- Cough symptoms lasting for more than 8 weeks
- Remaining free of acute upper respiratory tract infection for at least 4 weeks
- Agreed to participate in the trial and signed informed consent.
Key exclusion criteria (6 listed)
- Patients with serious systemic diseases (such as malignant tumors), bullae, severe uncontrolled asthma, and a history of major hemoptysis
- Systemic antibiotic use (except for maintenance low-dose macrolides) within 4 weeks
- Pregnancy or lactation
- Any known history of sensitivity to ATP or capsaicin
- Poor understanding of the test procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenosine TriphosphateAdenosine Triphosphate aerosol | Diagnostic test | Bx, Chronic cough, Control |
| capsaicincapsaicin aerosol | Diagnostic test | Bx, Chronic cough, Control |
Primary outcome
C5 (Provocant concentration eliciting at least 5 coughs)
Time frame: 18 months
Provocant concentration eliciting at least 5 coughs
6 secondary outcomes
ED50 (half maximal effective Dose)
Time frame: 18 months
Emax (effective concentration of provocant eliciting maximal cough count)
Time frame: 18 months
potency ratio
Time frame: 18 months
Difference in cough VAS score (a 10-point likert scale for assessing the global severity of cough, no subscale was applied)
Time frame: 18 months
The incidence of adverse events (i.e. dry throat , pharyngeal itching)
Time frame: 18 months
Cough dose ratio (CDR)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: PubMed 28179439Fowles HE, Rowland T, Wright C, Morice A. Tussive challenge with ATP and AMP: does it reveal cough hypersensitivity? Eur Respir J. 2017 Feb 8;49(2):1601452. doi: 10.1183/13993003.01452-2016. Print 2017 Feb.
- Background: PubMed 25409316Guan WJ, Gao YH, Xu G, Lin ZY, Tang Y, Li HM, Lin ZM, Zheng JP, Chen RC, Zhong NS. Capsaicin cough sensitivity and the association with clinical parameters in bronchiectasis. PLoS One. 2014 Nov 19;9(11):e113057. doi: 10.1371/journal.pone.0113057. eCollection 2014.
- Background: PubMed 16601085Torrego A, Haque RA, Nguyen LT, Hew M, Carr DH, Wilson R, Chung KF. Capsaicin cough sensitivity in bronchiectasis. Thorax. 2006 Aug;61(8):706-9. doi: 10.1136/thx.2005.049767. Epub 2006 Apr 6.
- Background: PubMed 12099777Fuller RW. Cough provocation tests: their clinical value. Pulm Pharmacol Ther. 2002;15(3):273-6. doi: 10.1006/pupt.2002.0355.
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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.
Ke-fang Lai, MD study chair
Guangzhou Institute of Respiratory Health Locations: China, Guangdong First Affiliated Hospital of Guangzhou Medical
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 Chronic Cough and Bronchiectasis, run by Guangzhou Institute of Respiratory Disease 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 6 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: status not confirmed, as of the sponsor's last update on 11 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-jie Guan, MD (+86-13826042052, battery203@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C5 (Provocant concentration eliciting at least 5 coughs) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03638063, which also lists 4 linked publications.
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 Feb 2020.