Actively Recruiting

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
ID07085975

The Safety, Feasibility, and Repeatability of Inhaled Adenosine 5'-Triphosphate Cough Challenges in Adults with Chronic Cough and Mild Asthma

Led by McMaster University · Updated on 2025-08-29

33

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, feasibility, and repeatability of inhaled adenosine 5'-triphosphate (ATP) cough challenges in healthy adults, patients with mild asthma, and those with chronic cough. This phase 1 study aims to better understand how these challenges can measure cough sensitivity and help identify patients who might respond to therapies targeting ATP. The study is sponsored by McMaster University and includes adults aged 18 and older. Participants will inhale increasing doses of ATP dissolved in saline through a vibrating mesh nebulizer. The study will observe reactions to these doses, including lung function changes and symptoms like wheeze, chest tightness, and shortness of breath. The study includes repeat ATP cough challenges within one week to assess consistency and will monitor for any adverse events throughout the process. During the study, participants will undergo spirometry to measure lung function and report symptoms using the mBorg scale. Oxygen saturation will also be monitored. Researchers will record cough counts and the doses of ATP that trigger specific cough responses. The study involves careful monitoring until the end of the ATP challenge and follow-up for one week to gather safety and repeatability data. Participation duration varies based on individual procedures.

CONDITIONS

Brief Title

The Safety, Feasibility, and Repeatability of Inhaled ATP Cough Challenges

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Healthy adults with normal lung function and no history of chronic cough or respiratory diseases
  • Adults with chronic cough lasting over 1 year with normal chest X-ray and no airflow obstruction, and insufficient cough improvement despite treatment or unexplained cough
  • Adults with mild, steroid-naïve asthma showing positive methacholine test and well-controlled symptoms, not using corticosteroids in past month
  • Women of child-bearing potential agreeing to use approved birth control during the study or women not of child-bearing potential
Not Eligible

You will not qualify if you...

  • Current or former smokers with over 5 pack-years (healthy individuals) or over 20 pack-years (cough or asthma patients) who quit less than 6 months ago
  • Unable to perform reliable lung function tests
  • Recent upper or lower respiratory infections within 6 weeks before study start
  • Presence of serious lung diseases like pulmonary embolism, lung cancer, emphysema, bronchiectasis, or interstitial lung disease
  • History of psychiatric illness, drug or alcohol abuse affecting study participation
  • Recent significant cardiovascular events within 3 months
  • Serious medical conditions or unstable medications
  • Immune system disorders, severe allergies, or receiving allergy-specific immunotherapy
  • Pregnant or breastfeeding women
  • Women of child-bearing potential not using approved birth control or not on hormonal birth control for at least 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 week

Participants inhale increasing concentrations of adenosine 5'-triphosphate to assess cough response and lung function.

1 to 2 visits for repeat ATP cough challenges

Trial Site Locations

Total: 1 location

1

Respiratory Research Lab

Hamilton, Ontario, Canada, L8N 3Z5

Actively Recruiting

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Research Team

I

Imran Satia, MD PhD

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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