Chronic Cough study: Adenosine
Official title The Safety, Feasibility, and Repeatability of Inhaled ATP Cough Challenges
ClinicalTrials.gov ID: NCT07085975
What this study is testing
What is Adenosine 5'-triphosphate?
An investigational inhaled agent being studied to assess cough hypersensitivity in chronic cough.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- Who it's for
- You may be able to join if you are healthy or have mild asthma and a long-lasting cough.
- What's involved
- You would breathe in a mist of a chemical called ATP to see if it makes you cough. The team will check how safe this test is and if it gives the same results each time.
- Time commitment
- The study involves several visits to the clinic to perform the breathing tests.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Normal spirometry; and
- No current or past medical history of chronic cough or other respiratory diseases.
You likely can't join if
- We will exclude healthy individuals meeting the following: (1) Are a current or former smoker with a \>5 pack-year history and abstinence ≤6 months;
- 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...
- History of psychiatric illness, drug, or alcohol abuse that could interfere with participation in the study.
See the full eligibility criteria
- Normal spirometry; and
- No current or past medical history of chronic cough or other respiratory diseases.
- We will exclude healthy individuals meeting the following: (1) Are a current or former smoker with a \>5 pack-year history and abstinence ≤6 months;
- 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...
- 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;
- Those with serious medical conditions or those who are not on stable medication(s) for their condition(s);
- Those with immune system disorders, severe allergy, or on allergy-specific immunotherapy;
- Any other condition, that, in the opinion of the qualified investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant;
- Pregnant or breastfeeding;
- Insufficient improvement in cough despite treatment targeting any underlying condition(s) contributing to the cough (RCC); or
- Cough for which an underlying cause has not been determined despite thorough investigation (UCC).
- Current smoker or ex-smoker with ≥20 pack-year history and abstinence ≤6 months;
- History or exacerbation or uncontrolled symptoms within the last month prior to the first study visit; and
- Unable to perform acceptable and reproducible spirometry;
- Unresolved symptoms of upper respiratory tract infection within 6 weeks prior to the first study visit;
- 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...
- 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;
- Those with serious medical conditions or those who are not on stable medication(s) for their condition(s);
- Those with immune system disorders, severe allergy, or on allergy-specific immunotherapy;
- Any other condition, that, in the opinion of the qualified investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant;
- Pregnant or breastfeeding;
- Do not agree to use a medically approved method of birth control for the duration of the study;
- Have not been using hormonal birth control for a minimum of 3 months prior to screening.
The study team makes the final eligibility decision.
Where it is enrolling
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hamilton, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.