NIPH Clinical Trials Search

KRP-DC125 Pivotal Study

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Chronic cough
Date of first enrollment	11/06/2026
Target sample size	160
Countries of recruitment
Study type	Interventional
Intervention(s)	Treatment group: The treatment group app is administered in addition to Standard of care. Control group: The control group app is administered in addition to Standard of care.

Outcome(s)

Primary Outcome	Cough frequency (average number of coughs per hour)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 75age old
Gender	Both
Include criteria	(1)Men or women aged at least 18 years and younger than 75 years (2)At Visit 1, the patient had a cough that had persisted for at least 8 weeks, and despite treatment in accordance with clinical practice guidelines, Investigators designated physician determined that medical intervention was necessary for the cough. (3)Based on the results of a chest X-ray or chest CT scan taken within the past two years prior to this visit and after the onset of the current cough episode (including a series of cough symptoms prior to the diagnosis of chronic cough), the patient has been determined not to have any abnormalities or serious lung diseases that are considered to be significantly affecting the current cough. (4)Regarding the current cough episode, the patient does not produce a clinically significant amount of sputum (generally more than approximately 2 tablespoons per day) on a daily basis.
Exclude criteria	(1)Currently smokes, quit smoking within the 6 months prior to Visit 1, or has a history of smoking exceeding 20 pack-years ((number of cigarettes smoked per day / 20) * number of years smoked). (2)Has accompanying vocal cord polyps or nodules. (3)The principal investigator or other designated personnel determined that the current cough episode is caused by a dysphagia-related cough, or that there is a strong suspicion that it is. (4)Patients with concurrent or a history of malignant tumors of the pharynx, larynx, or tongue; or patients with a history of malignant tumors other than those of the pharynx, larynx, or tongue within 5 years prior to Visit 1.