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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic cough | patients with chronic cough who remain clinically stable |
| |
| Bx | bronchiectasis patients who remain clinically stable |
| |
| Control | healthy controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adenosine Triphosphate | Diagnostic Test | Adenosine Triphosphate aerosol |
|
| Measure | Description | Time Frame |
|---|---|---|
| C5 (Provocant concentration eliciting at least 5 coughs) | Provocant concentration eliciting at least 5 coughs | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| ED50 (half maximal effective Dose) | 50% effective dose of provocant | 18 months |
| Emax (effective concentration of provocant eliciting maximal cough count) | effective concentration of provocant eliciting maximal cough count |
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Inclusion Criteria:
Exclusion Criteria:
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patients with chronic cough (including bronchiectasis) who remained clinically stable for at least 4 weeks
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-jie Guan, MD | Contact | +86-13826042052 | battery203@163.com | |
| Jing jing Yuan, Msc | Contact | +86-13502414649 | jacyyjj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ke-fang Lai, MD | Guangzhou Institute of Respiratory Health Locations: China, Guangdong First Affiliated Hospital of Guangzhou Medical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28179439 | Background | 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. | |
| 25409316 | Background | Guan 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. |
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| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| capsaicin | Diagnostic Test | capsaicin aerosol |
|
| 18 months |
| potency ratio | ATP/capsaicin potency ratio | 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 | 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) | 18 months |
| Cough dose ratio (CDR) | the ratio of cough count and dose/concentration | 18 months |
| 16601085 | Background | Torrego 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. |
| 12099777 | Background | Fuller RW. Cough provocation tests: their clinical value. Pulm Pharmacol Ther. 2002;15(3):273-6. doi: 10.1006/pupt.2002.0355. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |