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Tests treatment safety and results for Chronic Cough (CC)
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?
Adenosine 5'-triphosphate is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for chronic cough (cc).
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.
- What it's testing
- 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.
- 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
- Phase 1: Healthy individuals Eligible participants in Phase 1 will include healthy adults (≥18 years old) with:
- 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
- Phase 1: Healthy individuals Eligible participants in Phase 1 will include healthy adults (≥18 years old) with:
- 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;
- Women of child-bearing potential who:
- Do not agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of 3 months. Acceptable methods of birth control include...
- RCC/UCC for \>1 year, demonstrated by a normal chest radiograph and no airflow obstruction (FEV1/FVC\>0.7/LLN) with either:
- 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).
- Mild steroid-naïve asthma who demonstrate evidence of a positive screening methacholine (PC20\<16 mg/mL); symptoms of cough, shortness of breath, chest tightness, and wheeze, that, in the opinion of the qualified...
- 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
- Use of inhaled or oral corticosteroids within the last month prior to the first study visit. We will exclude participants meeting any of the following criteria from the study:
- 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;
- Female participants of child-bearing potential who:
- 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's taking place
- 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 - 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?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.