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 range18 Years

SexALL

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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
✕. History of psychiatric illness, drug, or alcohol abuse that could interfere with participation in the study.
✕. History of clinically-significant cardiovascular disease, including coronary artery disease, aortic aneurysm, or stroke in the last 3 months;

What they're measuring

The mean %FEV1 change from baseline at incremental doses of ATP

Timeframe: Until the end of the ATP cough challenge

Symptoms of wheeze measured on the mBorg scale at incremental doses of ATP

Timeframe: Until the end of the ATP cough challenge

Symptoms of chest tightness measured on the mBorg scale at incremental doses of ATP

Timeframe: Until the end of the ATP cough challenge

Symptoms of shortness of breath measured on the mBorg scale at incremental doses of ATP

Timeframe: Until the end of the ATP cough challenge

The mean change in oxygen saturations (SpO2) from baseline at incremental doses of ATP

Timeframe: Until the end of the ATP cough challenge

The intra-class correlation of measures obtained from repeat ATP cough challenges

Timeframe: Baseline to 1 week

The frequency of adverse events

Timeframe: Baseline to 1 week

Trial details

NCT IDNCT07085975

SponsorMcMaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Imran Satia, MD PhD

905-525-2100 satiai@mcmaster.ca

View on ClinicalTrials.gov More Chronic Cough (CC) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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
✕. History of psychiatric illness, drug, or alcohol abuse that could interfere with participation in the study.
✕. History of clinically-significant cardiovascular disease, including coronary artery disease, aortic aneurysm, or stroke in the last 3 months;

What they're measuring

The mean %FEV1 change from baseline at incremental doses of ATP

Timeframe: Until the end of the ATP cough challenge

Symptoms of wheeze measured on the mBorg scale at incremental doses of ATP

Timeframe: Until the end of the ATP cough challenge

Symptoms of chest tightness measured on the mBorg scale at incremental doses of ATP

Timeframe: Until the end of the ATP cough challenge

Symptoms of shortness of breath measured on the mBorg scale at incremental doses of ATP

Timeframe: Until the end of the ATP cough challenge

The mean change in oxygen saturations (SpO2) from baseline at incremental doses of ATP

Timeframe: Until the end of the ATP cough challenge

The intra-class correlation of measures obtained from repeat ATP cough challenges

Timeframe: Baseline to 1 week

The frequency of adverse events

Timeframe: Baseline to 1 week