The Safety, Feasibility, and Repeatability of Inhaled ATP Cough Challenges (NCT07085975) | Clinical Trial Compass
RecruitingPhase 1
The Safety, Feasibility, and Repeatability of Inhaled ATP Cough Challenges
Canada33 participantsStarted 2025-08-05
Plain-language summary
The inhalation of adenosine 5'-triphosphate (ATP) to evoke cough (ATP cough challenge) is becoming increasingly used as a tool to measure cough hypersensitivity in patients with chronic cough. However, the safety, feasibility, and repeatability of this procedure is not widely known. In this study, we will perform ATP cough challenges in healthy individuals and in patients with mild asthma and chronic cough to better understand the safety, feasibility, and repeatability of these challenges. Such information will guide the future conduct of ATP cough challenges to measure cough hypersensitivity and identify patients who may better respond to ATP-blocking therapies.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Normal spirometry; and
. No current or past medical history of chronic cough or other respiratory diseases.
Exclusion criteria
. Unable to perform acceptable and reproducible spirometry;
. Have unresolved symptoms of upper respiratory tract infection within 6 weeks prior to the first study visit;
. Have had a lower respiratory tract infection or pneumonia within 6 weeks prior to the first study visit;
. Presence of other primary pulmonary disorders, including pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, radiologically-proven emphysema, severe bronchiectasis, or severe interstitial lung disease; or
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The mean %FEV1 change from baseline at incremental doses of ATP
Timeframe: Until the end of the ATP cough challenge
2
Symptoms of wheeze measured on the mBorg scale at incremental doses of ATP
Timeframe: Until the end of the ATP cough challenge
3
Symptoms of chest tightness measured on the mBorg scale at incremental doses of ATP
Timeframe: Until the end of the ATP cough challenge
4
Symptoms of shortness of breath measured on the mBorg scale at incremental doses of ATP
Timeframe: Until the end of the ATP cough challenge
5
The mean change in oxygen saturations (SpO2) from baseline at incremental doses of ATP
Timeframe: Until the end of the ATP cough challenge
6
The intra-class correlation of measures obtained from repeat ATP cough challenges