Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2025-12-24 @ 1:53 PM
NCT ID:
NCT07070895
Eligibility Criteria:
Inclusion Criteria:
* Age 21 or older.
* Currently suffering from a cough that started at least 8 weeks ago that is largely unproductive (i.e., at least 50% of the time the cough produces zero mucus that needs to be spit out or swallowed).
* Normal chest X-ray or chest CT scan at some point that was prescribed specifically for their cough.
* At least one physician visit for cough with standard-of-care therapy but inadequate symptom relief.
* Stability of treatment: willing to avoid new cough treatments during study or report changes if they occur.
* Ability to comply: willing/able to wear the watch daily for the required duration of study and to complete all required questionnaires.
* Informed consent: understanding of the study procedures and agreement to comply with protocol.
Exclusion Criteria:
* Recent upper respiratory infection (past 4 weeks).
* History of hemoptysis (coughing up blood) since onset of the current cough.
* Current smoker (incl. vaping) of any substance.
* ≥10 consecutive pack-years smoking history within \<10 years prior to screening.
* Diagnosed with a chronic lung condition (COPD, emphysema, lung cancer, IPF, chronic bronchitis, asthma). Note: Suspected asthma without confirmed diagnosis or benefit from asthma therapy is not an exclusion.
* Current or past head/neck cancer.
* Difficulty swallowing.
* On ACE inhibitors, such as Benzapril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik)
* Prior treatment for cough by a speech-language pathologist.
* Living with another individual with a frequent cough that would interfere with monitoring.
* Participation in any cough intervention study within 30 days or 5 half-lives of the intervention.
* Major scheduled surgery during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07070895
Study Brief:
Protocol Section:
NCT07070895