Health TrialsbyHealthPanel

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

ConditionsChronic Cough (CC)Asthma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Normal spirometry; and

No current or past medical history of chronic cough or other respiratory diseases.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Adenosine 5'-triphosphate

    Drug

    Participants will inhale increasing doubling concentrations of adenosine 5'-triphosphate dissolved in 0.9% saline through the Aerogen Solo vibrating mesh nebulizer.

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Adenosine 5'triphosphateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Until the end of the ATP cough challenge
2

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

Time frame
Until the end of the ATP cough challenge
3

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

Time frame
Until the end of the ATP cough challenge
4

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

Time frame
Until the end of the ATP cough challenge

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Source ClinicalTrials.gov
Apply now