Actively Recruiting
The Safety, Feasibility, and Repeatability of Inhaled ATP Cough Challenges
Led by McMaster University · Updated on 2025-08-29
33
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Safety, Feasibility, and Repeatability of Inhaled ATP Cough Challenges
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- For Phase 1: Healthy adults with normal lung function and no current or past chronic cough or respiratory diseases
- For Phase 2: Adults with refractory or unexplained chronic cough for over 1 year with normal chest X-ray and no airflow obstruction
- For Phase 2: Adults with mild steroid-naive asthma showing positive methacholine test and well-controlled respiratory symptoms
- Female participants of child-bearing potential must agree to use approved birth control methods during the study and have been on hormonal birth control for at least 3 months if applicable
- Females not of child-bearing potential are defined as those sterilized or post-menopausal for at least 1 year prior to screening
You will not qualify if you...
- Current or former smokers with more than 5 pack-years history and less than 6 months abstinence (Phase 1)
- Current or former smokers with more than 20 pack-years history and less than 6 months abstinence (Phase 2 RCC/UCC or asthma cohorts)
- Unable to perform acceptable and reproducible lung function tests
- Unresolved upper respiratory infection symptoms within 6 weeks before the first visit
- Lower respiratory infection or pneumonia within 6 weeks before the first visit
- Other primary lung disorders such as pulmonary embolism, hypertension, lung cancer, cystic fibrosis, emphysema, severe bronchiectasis, or severe interstitial lung disease
- History of psychiatric illness, or drug and alcohol abuse interfering with study participation
- Recent significant cardiovascular disease including coronary artery disease, aortic aneurysm, or stroke within 3 months
- Serious medical conditions or unstable medication use
- Immune system disorders, severe allergies, or receiving allergy-specific immunotherapy
- Any condition that may affect ability to complete the study or pose risk according to the investigator
- Pregnant or breastfeeding
- Female participants of child-bearing potential not agreeing to use approved birth control or not using hormonal birth control for at least 3 months prior to screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Respiratory Research Lab
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
Research Team
I
Imran Satia, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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