Testing Adenosine 5'-triphosphate for chronic cough (CC)

Exclusion

• −We will exclude healthy individuals meeting the following:
• −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
• −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);
• −Any other condition, that, in the opinion of the qualified investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant;
• −Women of child-bearing potential who:
• −Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →: Patients with RCC/UCC and mild-steroid naïve asthma
• −Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
• −Eligible participants will include adults (≥18 years old) with:
• −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → methacholine (PC20\<16 mg/mL); symptoms of cough, shortness of breath, chest tightness, and wheeze, that, in the opinion of the qualified investigator, are well-controlled; and those have not used inhaled or oral corticosteroids for the past month.
• −Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
• −CohortCohortA group of participants sharing a characteristic, followed together.Read more →-specific exclusion criteria include the following:
• −For the RCC/UCC cohort:
• −For the mild steroid-naïve asthma cohort:
• −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 disease;
• −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);
• −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;
• −Female participants of child-bearing potential who:
• −Do not agree to use a medically approved method of birth controlControl groupThe group a new treatment is measured against.Read more → for the duration of the study;
• −Have not been using hormonal birth control for a minimum of 3 months prior to screening.
• −Pregnant or breastfeeding;
• −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 oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening. Females who are not of child-bearing potential will be defined as females who have undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening.
• −Pregnant or breastfeeding;
• −Those with immune system disorders, severe allergy, or on allergy-specific immunotherapy;
• −Those with immune system disorders, severe allergy, or on allergy-specific immunotherapy;
• −(1) Are a current or former smoker with a \>5 pack-year history and abstinence ≤6 months;
• −(1) Current smoker or ex-smoker with ≥20 pack-year history and abstinence ≤6 months;
• −Current smoker or ex-smoker with ≥20 pack-year history and abstinence ≤6 months;