NCT03638063

ATP and Capsaicin Cough Provocation Test in Chronic Cough and Bronchiectasis

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Chronic Cough
• Bronchiectasis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Adenosine Triphosphate	Adenosine Triphosphate aerosol
DIAGNOSTIC_TEST	capsaicin	capsaicin aerosol

Timeline

• Start date: 2018-10-29
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2018-08-20
• Last updated: 2020-02-11

Locations

1 site across 1 country: China